[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"masld\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:masld":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,73,98,128,154,191,213,240,262,287,312,345,372,399,422,452,478,507,541,575,599,621,652,687,717],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":46,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751",false,"NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist","ALL","18 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"NA","Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Obesity","Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[47,48,49,50,51,52,53,54,55,56,57,58,59],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)","RECRUITING","2026-06-23",{"date":63,"type":64},"2026-06-25","ACTUAL",{"date":66,"type":64},"2025-06-24",{"date":68,"type":21},"2028-06",{"name":70,"class":71},"Pichamol Jirapinyo, MD, MPH","OTHER",2,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100644359","fib-4-cut-offs-for-liver-fibrosis-in-obese-endocrinology-patients-100644359","NCT07663188","FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients","Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy","OBEMASLD","Inclusion Criteria:\n\n* Obesity class I or II (body mass index, BMI ≥ 30 kg\u002Fm² and ≤ 40 kg\u002Fm²)\n* Age \\> 18 years and \\\u003C 65 years.\n* Ability to provide written informed consent after adequate information on the study objectives.\n* Arm 1: patients with FIB-4 ≥ 1.3.\n* Arm 2: patients with FIB-4 \\\u003C 1.3.\n\nExclusion Criteria:\n\n* Lack of signed informed consent.\n* Pregnancy or breastfeeding.\n* Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis).\n* Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).","65 Years",{"count":83,"type":21},400,"OBSERVATIONAL","This single-center, prospective observational study aims to assess the accuracy of FIB-4 cut-offs in identifying liver fibrosis in obese patients attending an endocrinology outpatient clinic in Italy.\n\nAll consecutive eligible patients undergo routine blood tests and liver elastography (FibroScan) as part of clinical practice; FIB-4 values will be calculated and compared with liver stiffness measurements to evaluate the performance of FIB-4 thresholds for directing patients to FibroScan and hepatology care.",[33],[33,88],"FIB-4","NOT_YET_RECRUITING","2026-06-17",{"date":61,"type":64},{"date":93,"type":21},"2026-09-01",{"date":95,"type":21},"2028-09-01",{"name":97,"class":71},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100643233","effects-of-peanut-consumption-on-adults-with-metabolic-associated-fatty-liver-disease-100643233","NCT07646197","Effects of Peanut Consumption on Adults With Metabolic Associated Fatty Liver Disease","Impacts of Peanut Intake on Hepatic Markers and Gut Microbiota in Adults With MASLD","Inclusion Criteria:\n\n* 30-70 years\n* do not consume peanut\u002Fpeanut butter\u002Ftreenut\u002Fseeds \\> \u002Fweek\n* at least one encounter-related (stage F0\u002FF1) MASLD diagnosis (K76.0)\n* Able to understand, speak, and read English\n* Mentally competent to consent\n\nExclusion Criteria:\n\n* Food allergy to peanuts or peanut-containing products\n* With alcohol use disorder (AUDIT screening)\n* Leukemia\n* Lymphoma\n* Other types of cancer\n* Heart or cardiovascular diseases (such as heart attack, stroke, heart failure)\n* Kidney diseases (such as chronic kidney disease, kidney transplant, renal insufficiency such as renal failure requiring dialysis)","30 Years","70 Years",{"count":108,"type":21},125,[24],"The aim of this randomized interventional trial is to understand the effects of peanut consumption on patients with metabolic associated fatty liver. The main goal is to investigate if patients who consume peanuts have improved liver marker tests as well as metabolic profile. We will also investigate how peanuts alter the gut microbes and liver fat content in patients with metabolic associated fatty liver.\n\n* Participants will be randomized into intervention (peanut consumption for 12 weeks) and control (regular diet) arm.\n* Stool sample and blood (for biomarkers) collection across both arms at baseline and post-intervention\n* Daily log to be completed for tracking peanut consumption\n* 2-day Dietary recall at baseline, during Week 6 and Week 12\n* Poat intervention Fibro scans for participants with baseline scans available",[33,55],[113,114,115,116,117,118],"fatty liver","masld","peanut","hepatic","intervention","gut microbe","2026-06-09",{"date":121,"type":64},"2026-06-12",{"date":119,"type":21},{"date":124,"type":21},"2028-06-09",{"name":126,"class":71},"Henry Ford Health System",1,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":33,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":151,"locationsCount":127},"100642697","lipidomic-and-multi-omics-profiling-of-fatty-liver-disease-in-people-with-and-without-hiv-100642697","NCT07640880","Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV","Multi-Omics Characterization of Lipid Metabolic Reprogramming in People With HIV Versus HIV-Negative Metabolic Dysfunction-Associated Steatotic Liver Disease","Inclusion Criteria:\n\n* Age 18-80 years\n* Able to provide written informed consent and cooperate with blood sample collection and clinical data recording\n\nFor Group 1 (Treatment-naive people with HIV and MASLD):\n\n* Confirmed HIV infection with no prior antiretroviral therapy (treatment-naive)\n* Diagnosis of MASLD per the 2024 Chinese Guidelines: hepatic steatosis confirmed by imaging or histology (≥5% macrovesicular steatosis), exclusion of excessive alcohol consumption (\\>210 g\u002Fweek for men, \\>140 g\u002Fweek for women), and at least one metabolic cardiovascular risk factor\n\nFor Group 2 (HIV-negative individuals with MASLD):\n\n* HIV-negative\n* Diagnosis of MASLD as defined above\n\nFor Group 3 (Healthy Controls):\n\n* HIV-negative\n* Normal liver morphology on abdominal ultrasonography within the past year, with no evidence of hepatic steatosis\n* Matched to MASLD groups by age (within 5 years), sex, and BMI (within 3 kg\u002Fm²)\n\nExclusion Criteria:\n\n* Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation\n* Pregnancy or lactation\n* Active severe infectious disease (other than HIV for Group 1)\n* Severe critical illness or major organ failure",true,"80 Years",{"count":138,"type":21},120,"Metabolic dysfunction-associated steatotic liver disease (MASLD), commonly known as fatty liver disease, is increasingly prevalent worldwide. People living with HIV (PWH) face a higher risk of developing MASLD due to chronic immune activation and long-term antiretroviral therapy, yet whether the underlying biological changes differ from those in HIV-negative individuals with MASLD remains unknown.\n\nThis prospective observational study will enroll three groups: PWH with MASLD, HIV-negative individuals with MASLD, and healthy controls without liver disease. A single fasting blood sample will be collected from each participant. Using targeted lipidomics, proteomics, and transcriptomics platforms, researchers will compare plasma molecular profiles across the three groups to identify MASLD-specific lipid signatures, characterize metabolic pathway dysregulation, and discover potential blood-based biomarkers for non-invasive diagnosis of MASLD.\n\nFindings from this study may help explain how HIV infection alters lipid metabolism in the context of MASLD and support the development of HIV-specific diagnostic tools for fatty liver disease.",[33,141],"HIV (Human Immunodeficiency Virus)",[143,33,144],"HIV","lipidomics","2026-06-05",{"date":147,"type":64},"2026-06-11",{"date":149,"type":21},"2026-06-01",{"date":93,"type":21},{"name":152,"class":153},"Yinzhong Shen","OTHER_GOV",{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":167,"conditions":168,"keywords":176,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":72},"100561325","phase-2-digoxin-in-nash-codin-100561325","NCT06588699","Digoxin In NASH (CODIN)","Clinical Trial of Oral Digoxin In NASH (CODIN)","CODIN","Inclusion Criteria\n\n* Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening\n* Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening\n* Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening\n* Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization Exclusion Criteria\n\nLiver-related:\n\n* Documented causes of chronic liver disease other than NASH\n* History or clinical evidence of cirrhosis or portal hypertension\n* History of positive HBsAg, positive anti-HIV, positive HCV-RNA\n* AST or ALT \\> 5 times upper limit of normal (ULN) at screening\n* Total bilirubin \\> 1.5 mg\u002FdL at screening unless conjugated bilirubin is \\\u003C 1.5 × ULN\n* International normalized ratio (INR) \\> 1.3 at screening\n* Known or suspected alcohol use \\> 20 g\u002Fday for women or \\> 30 g\u002Fday for men\n* Treatment initiation or dose adjustment of vitamin E, pioglitazone, GLP-1RA, or SGLT-2 inhibitors within 30 days of signing the informed consent or 30 days prior to liver biopsy\n* Treatment initiation or anticipated treatment (\\>14 consecutive days) with medications known to affect steatosis (e.g., systemic corticosteroids, tamoxifen, valproic acid, methotrexate, tetracycline or amiodarone) within 30 days of signing the informed consent or 30 days prior to liver biopsy\n\nCardiac related:\n\n* Heart rate less than 60 bpm at screening (visit 1) or at baseline (visit 2)\n* Current diagnosis of severe aortic valve disease\n* History of Accessory arterio-ventricular pathway (e.g., Wolf-Parkinson-White syndrome)\n* History of complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device\n* Current diagnosis of permanent atrial fibrillation\n* Any of the following within the previous 6 months of signing informed consent: myocardial infarction, percutaneous intervention, pacemaker\u002Fimplantable cardiac device implantation, cardiac surgery, or stroke\n* Current use of the following medications: inotropic drugs such as (dopamine, dobutamine, noradrenaline, milrinone), anti-arrhythmics (amiodarone, dofetilide, sotalol, dronedarone, digoxin), parathyroid hormone analog (teriparatide), sympathomimetics (epinephrine, norepinephrine, dopamine), neuromuscular blocking agents (succinylcholine), calcium supplement, nondihydropyridine calcium channel blockers, ivabradine, and disulfiram.\n\nObesity related:\n\n* Treatment initiation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) with orlistat, zonisamide, topiramate, phentermine, bupropion, and naltrexone alone or in combination or any other medication that could promote weight loss in the opinion of the investigator\n* Participation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) in an organized diet-based weight reduction program (e.g., WeightWatchers, Optifast)\n* Recent surgical treatment (\\\u003C6 months of signing informed consent) for obesity\n\nGeneral safety related:\n\n* Presence or history of malignant neoplasms (in the past 5 years prior to screening), except basal and squamous cell skin cancer and any carcinoma in-situ\n* Surgery scheduled or anticipated during the trial period, except for minor surgical procedures, in the opinion of the investigator\n* Language barrier, mental incapacity, unwillingness, or inability to adequately understand or comply with study procedures\n* Known or suspected hypersensitivity to the trial product or related products including allergy to milk, egg, soy, peanuts, and sulfites\n* Recent participation (within 90 days prior to signing the informed consent) in any clinical trial of an approved or non-approved investigational medicinal product\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* TSH \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL at screening\n* Current use of the following medications: calcium supplementation, parathyroid hormone analog (teriparatide), neuromuscular blocking agents (succinylcholine) and disulfiram.\n* Claustrophobia to an extent that would prevent tolerance of MRI\n* Metallic implant that would prevent MRI examination including, metallic foreign body, aneurysm clips, vascular grafts or cardiac implants, neural stimulator, cochlear implant, metallic contraceptive device, body piercing that cannot be removed, cochlear implant, or any other contraindication to MRI","75 Years",{"count":164,"type":21},144,[166],"PHASE2","Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.",[169,170,171,172,173,33,174,175],"NASH","NAFLD","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Mash","MASH With Fibrosis","Fatty Liver Disease","Fatty Liver Disease, Nonalcoholic",[169,34,177,178,179,180,181,170],"Metabolic dysfunction associated steatohepatitis","Digoxin","Drug repurposing","Liver fibrosis","Fatty liver disease","2026-05-22",{"date":184,"type":64},"2026-05-26",{"date":186,"type":64},"2025-06-05",{"date":188,"type":21},"2029-01",{"name":190,"class":71},"Yale University",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":127},"100638111","safety-and-efficacy-of-finerenone-in-metabolic-dysfunction-associated-steatotic-liver-diseasemasldnafld-related-cirrhosis-patients-with-ascites-in-prevention-of-chronic-kidney-disease-100638111","NCT07585526","Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD\u002FNAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease.","Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD\u002FNAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease. A Randomized Control Trial.","Inclusion Criteria:\n\n1. Age \\> 18 years \\\u003C80years\n2. Patient of MASLD\u002F NAFLD cirrhosis with clinical ascites\n3. Stable eGFR-(\\>60 ml\u002Fmin\u002F1.73m2) calculated using MDRD-6 equation: eGFR (ml\u002Fmin\u002F1.73 m2) = 170 × (Scr)-0.999 × (Age)-0.176 × (0.762 if patient is female) × (1.180 if black) × (SUN)-0.170 × (Albumin)0.318\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years \\>80 years\n2. K\u002FC\u002FO systemic hypertension.\n3. Coagulopathy- INR \\>2.5\n4. Post TIPS\n5. CTP class C\n6. Any intrinsic\u002Fstructural kidney disease.\n7. Refractory Ascites\n8. Patient with HCC(outside MILAN criteria) or portal vein thrombosis\n9. Pregnancy or Lactating mother\n10. Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment\n11. Patients with anuria, acute renal failure, or Addison's disease\n12. Heart failure (NYHA II to IV)\n13. History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment\n14. Ongoing drug or alcohol abuse\n15. Uncontrolled type 2 DM ( HbA1C \\> 9)\n16. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment\n17. Coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]) or valvular repair\u002Freplacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomisation\n18. Diagnosed Mixed ascites (additional etiology of ascites apart from portal hypertension)\n19. Patients who are on spirinolactone with stable ascites in the past 12 weeks\n20. Refusal to give consent",{"count":199,"type":21},160,[24],"Renal dysfunction is a frequent and clinically important complication in cirrhosis, and MASLD\u002FNAFLD is associated with increased risk of incident CKD; however, finerenone has not been specifically studied in MASLD-cirrhosis populations despite proven cardiorenal benefits in diabetic CKD. This monocentric, open-label, randomized controlled trial at the Department of Hepatology, ILBS, New Delhi will enroll 160 adults (18-80 years) with MASLD\u002FNAFLD cirrhosis, clinical grade I-II ascites, and stable eGFR ≥60 mL\u002Fmin\u002F1.73 m² (MDRD-6), with key exclusions including CTP class C, refractory ascites, significant coagulopathy, intrinsic kidney disease, recent major cardiovascular events, and other protocol-defined contraindications. Participants will receive standard medical treatment (dietary measures, diuretics as indicated, metabolic control, complication management, albumin\u002Fbeta-blockers as needed) and will be randomized to finerenone (5 mg\u002Fday uptitrated to 10-20 mg\u002Fday) versus spironolactone (50 mg\u002Fday uptitrated to 100-200 mg\u002Fday). The primary endpoint is incident CKD at 6 months , defined as sustained eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² over 3 months. Secondary endpoints include MAKE\u002FMACE\u002FMALO at 6 months, drug-related adverse events (including hyperkalemia, hyponatremia, hypotension, hyperuricemia), AKI\u002FAKD episodes, renal biomarkers (e.g., cystatin C, UPCR), ascites response, liver severity scores (MELD 3.0\u002FMELD-Na\u002FCTP), and metabolic\u002Finflammatory\u002Fendothelial markers (e.g., HbA1c, HOMA-IR, hsCRP, vWF). Sample size (n=160; 80\u002Farm) is powered to detect an absolute 20% reduction in CKD progression (35% to 15%) with 80% power and 5% alpha (10% dropout), with intention-to-treat analyses including Kaplan-Meier and Cox regression methods.",[33,203],"Chronic Kidney Diseases","2026-05-09",{"date":206,"type":64},"2026-05-13",{"date":208,"type":21},"2026-04-15",{"date":210,"type":21},"2028-03-31",{"name":212,"class":71},"Institute of Liver and Biliary Sciences, India",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":221,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":238,"locationsCount":127},"100634873","integrated-ultrasound-derived-fat-fraction-and-2d4d-heartai-for-cardiovascular-risk-management-in-patients-with-masld-100634873","NCT07545343","Integrated Ultrasound-Derived Fat Fraction and 2D\u002F4D HeartAI for Cardiovascular Risk Management in Patients With MASLD","Integration of Ultrasound-Derived Fat Fraction With 2D and 4D HeartAI for Cardiovascular Risk Management in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Observational Cohort Study","MUCHAI","Inclusion Criteria:\n\n* Adults aged 18 to 75 years\n* Diagnosis of MASLD based on imaging or biopsy\n* Presence of at least one cardiometabolic risk factor, such as BMI ≥25 kg\u002Fm², type 2 diabetes mellitus, or dyslipidemia\n* No contraindication to ultrasound imaging\n\nExclusion Criteria:\n\n* Significant alcohol consumption: \\>20 g\u002Fday for women or \\>30 g\u002Fday for men Secondary causes of hepatic steatosis, such as viral hepatitis or autoimmune liver disease\n* Known advanced heart failure (New York Heart Association class III-IV)\n* Recent cardiovascular event within 6 months\n* Pregnancy\n* Inability to complete follow-up",{"count":222,"type":21},700,"This prospective observational cohort study aims to evaluate the association between liver fat fraction measured by ultrasound-derived fat fraction (UDFF) and cardiac functional parameters assessed by 2D and 4D HeartAI in adult patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo baseline assessment and repeat evaluations at 6, 12, and 36 months. The study will assess the diagnostic performance of integrated UDFF-HeartAI analysis for detecting subclinical cardiac abnormalities and identify predictors of cardiovascular risk progression and major adverse cardiovascular events in patients with MASLD.",[33,225,226],"Cardiovascular (CV) Risk","Subclinical Cardiovascular Impairments",[228,229,230,231],"Ultrasound-Derived Fat Fraction","Echocardiography","Cardiovascular Events","Major Adverse Cardiovascular Events","2026-04-16",{"date":234,"type":64},"2026-04-22",{"date":149,"type":21},{"date":237,"type":21},"2030-05-31",{"name":239,"class":71},"First Affiliated Hospital, Sun Yat-Sen University",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":127},"100632830","accurate-point-of-care-liver-disease-diagnostics-phase-2-100632830","NCT07518784","Accurate Point of Care Liver Disease Diagnostics (Phase 2)","Accurate Point of Care Liver Disease Diagnostics","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Known or clinically suspected MASLD\n* BMI greater than 27 kg\u002Fm\\^2 and less than 45 kg\u002Fm\\^2 at the time of referral\n* Ability to lie on LiverScope® device table for about 60 minutes\n* Ability to hold breath repeatedly for about 20 seconds during MR and LiverScope® exams\n* Willing and able to undergo all study procedures\n\nExclusion Criteria:\n\n* UCSD study personnel or Livivos study personne\n* Contraindications to MR\n* Potential participant states that she knows that she is pregnant, thinks she may be pregnant, or states that she is trying to become pregnant.\n* Known chronic liver disease other than MASLD",{"count":248,"type":21},26,"This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as NAFLD). Conventional MR scanners use magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small, portable MR-based device that uses similar, but simplified technology, and can be used on top of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical use.\n\nIn this second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations.\n\nStudy participants will be asked to complete a one-time visit which includes:\n\n* LiverScope exam\n* MR exam\n* FibroScan exam (optional)\n* Blood draw\n* Completion of study questionnaires",[33,251,170,252],"MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)","NAFLD (Nonalcoholic Fatty Liver Disease)","2026-04-01",{"date":255,"type":64},"2026-04-09",{"date":257,"type":21},"2026-04-08",{"date":259,"type":21},"2026-06-30",{"name":261,"class":71},"University of California, San Diego",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":127},"100622340","a-study-of-electronic-clinical-decision-support-tools-for-steatotic-liver-disease-100622340","NCT07382349","A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease","Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease","eMPOWER","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Outpatient clinic visit (in-person or telemedicine) at a participating clinic site\n* Demonstrated Screening Need due to High Risk Profile, which includes the following: Diagnostic Codes for MASLD or Hepatic Steatosis on Imaging PLUS at least one cardiometabolic risk factors; OR Chronically Elevated Liver Enzymes (\\> 6 months); OR patient with impaired glycemic control (prediabetes\u002Fdiabetes); OR 2 or more cardiometabolic risk factors present\n\nExclusion Criteria:\n\n* Solid Organ Transplant Recipient\n* Existing Hepatology Relationship Evidenced by Prior Hepatology Visit Within 3 Years\n* Active Cancer Diagnoses\n* Diagnoses for Alcohol-Related Conditions\n* Pregnant Individuals\n* Receiving Palliative Care Services",{"count":271,"type":21},7200,[24],"The overall objectives of this study are to determine the effectiveness of a participant-specific guided electronic decision support system on provider decision making for participants with metabolic-dysfunction associated steatotic liver disease (MASLD), and to determine the acceptance and barriers for use of an electronic health record embedded algorithm for MASLD care management within ambulatory primary care, endocrinology, and general gastroenterology settings.",[33],[276,33,277],"Electronic Health Record","Clinical Decision Support","2026-01-31",{"date":280,"type":64},"2026-02-04",{"date":282,"type":21},"2026-07",{"date":284,"type":21},"2030-02",{"name":286,"class":71},"Vanderbilt University Medical Center",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":293,"maxAge":18,"enrollmentInfo":294,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":127},"100570408","quantitative-ultrasound-to-assess-steatotic-liver-disease-in-children-100570408","NCT06706856","Quantitative Ultrasound to Assess Steatotic Liver Disease in Children","Inclusion Criteria:\n\n* Age 9 to 18 years\n* Presence of risk factors for having MASLD\n* Ability and willingness of participant or legal guardian\u002Fparent to give written informed consent\n* Participant is willing to give written assent\n* Able and willing to undergo all study procedures\n\nExclusion Criteria:\n\n* Known liver disease other than MASLD\n* Pregnant or trying to become pregnant\n* Inability to undergo an MR study: weight exceeding scanner table limit, waist circumference \\> 140 cm, claustrophobie, and\u002For metal implants.","9 Years",{"count":138,"type":21},"This research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. The investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver MRI.\n\nThe investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices.\n\nOur goals are:\n\n* To assess the accuracy of the advanced ultrasound analysis techniques in children\n* To implement and assess these advanced technique on small handheld ultrasound devices, if possible",[33,297],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease",[33,299,300,301,302,303],"steatosis","quantitative ultrasound","quantitative MRI","fat fraction","PDFF","2026-01-18",{"date":306,"type":64},"2026-01-21",{"date":308,"type":64},"2024-09-23",{"date":310,"type":21},"2029-06-30",{"name":261,"class":71},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":320,"maxAge":81,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":127},"100618072","hepatic-gene-response-to-intravenous-glucose-in-obese-patients-with-and-without-masld-undergoing-bariatric-surgery-100618072","NCT07326865","Hepatic Gene Response to Intravenous Glucose in Obese Patients With and Without MASLD Undergoing Bariatric Surgery","Glucose IV and Its Hepatic Outcomes After a Metabolic Stress Test During Bariatric Surgery in Obese Patients With and Without MASLD","GHAST","Inclusion Criteria:\n\nTo be eligible to participate in this study, a subject must meet all of the following criteria:\n\nAdult individuals, age \\>35 \\\u003C 65 years old. Stable weight (no more than 3% TWL of initial body weight from screening to surgery) Subjects should be able to give informed consent Subjects agree to have tissue biopsies performed during surgery, that is 2 liver, subcutaneous, visceral and omental biopsies plus a one-time jejunal biopsy.\n\nFor obese non-MASLD patients:\n\n* Adult individuals, age \\>35 \\\u003C 65 years old.\n* BMI ≥ 40 kg\u002Fm², or a BMI ≥ 35 kg\u002Fm² with an obesity-related comorbidity\n* No MASLD based on Fibroscan\n* Estimated glomerular filtration rate (eGFR) \\> 60mL\u002Fmin\u002F1.73m2\n\nFor obese MASLD patients:\n\n* MASLD diagnosis according to Fibroscan\n* Compensated liver disease with the following hematologic and biochemical criteria on entry into study:\n\n  * ALAT \\\u003C10x ULN\n  * Hemoglobin \\> 11g\u002FdL for females and 12 g\u002FdL for males\n  * White blood cell (WBC) \\> 2.5 K\u002F μL\n  * Neutrophil count \\> 1.5 K μL\n  * Platelets \\> 100 K\u002FμL\n  * Total bilirubin \\\u003C35 μmol\u002FL\n  * Albumin \\>30 g\u002FL\n  * TP \\>80% or INR \\\u003C1.4\n  * Serum creatinine \\\u003C1.3 mg\u002FdL (men) or \\\u003C1.1 mg\u002FdL (women) or\n* Estimated glomerular filtration rate (eGFR) \\> 60mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Use of metformin and SGLT2\u002F exogenous insulin\u002FGLP-1 RA\n* Primary lipid disorder\n* Known genetic basis for insulin resistance or glucose intolerance\n* All medical and psychiatric conditions except for obesity related diseases.\n* Uncontrolled hypertension (RR \\> 150\u002F95 mmHg)\n* Chronic kidney disease (creatinine \\> 150 umol\u002FL)\n* Pregnancy, females who are breastfeeding\n* Evidence of another form of liver disease\n* History of sustained excess alcohol ingestion: daily consumption \\>30g\u002Fday (3 drinks per day) for males and \\>20 g\u002Fday (2 drinks per day) for females\n* Significant systemic or major illnesses other than liver disease, including congestive heart failure (class C and D of the AHA), unstable coronary artery disease, cerebrovascular disease, pulmonary disease, kidney failure, organ transplantation, serious psychiatric disease, active malignancy, compromised immunity\n* Body mass index (BMI) \\>45 kg\u002Fm2\n* Type 1 or type 2 diabetes\n* Hemostasis disorders or current treatment with anticoagulants\n* Known heart failure\n* Contra-indication for liver biopsy History of\u002For current cardiac dysrhythmias and\u002For a history of cardiovascular events including myocardial infarction, except patients with only well-controlled hypertension","35 Years",{"count":322,"type":21},40,[24],"The goal of this clinical trial is to learn how the liver responds to sugar in people with obesity who are having bariatric surgery. Researchers want to understand differences between people with and without metabolic associated steatotic liver disease (MASLD).\n\nThe main question is:\n\nDoes giving sugar directly into the vein change how liver genes work in people with and without MASLD?\n\nResearchers will compare:\n\n* People with MASLD who receive sugar\n* People with MASLD who receive saline (salt water)\n* People without MASLD who receive sugar\n* People without MASLD who receive saline\n\nDuring surgery, participants will:\n\n* Receive either a sugar solution (35 grams of glucose in 150 mL fluid) or saline\n* Have small samples (biopsies) taken from the liver and fat tissue before and 45 minutes after the infusion\n* Provide blood samples to measure sugar, insulin, and other metabolites\n* Provide a one-time sample of intestinal tissue that is normally removed during surgery\n\nThis study may help explain why MASLD develops and how the liver reacts to sugar. The results could lead to new ways to understand and treat liver disease in people with obesity.",[33],[327,27,328,329,330,331,332,333,334,335],"MASLD (Metabolic Associated Steatotic Liver Disease)","Bariatric surgery","Roux-en-Y gastric bypass (RYGB)","[6,6-D2]-labeled glucose","Hepatic gene expression","RNA sequencing","Adipose tissue transcriptomics","Metabolomics","Postprandial metabolism","2025-12-25",{"date":338,"type":64},"2026-01-08",{"date":340,"type":64},"2025-11-12",{"date":342,"type":21},"2027-05",{"name":344,"class":71},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":135,"sex":17,"minAge":352,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":360,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":127},"100541413","high-fructose-diet-the-gut-microbiome-and-metabolic-health-100541413","NCT06329544","High Fructose Diet, the Gut Microbiome, and Metabolic Health","The Effects of a High Fructose Diet on the Gut Microbiome and Metabolic Health: A Controlled Clinical Intervention Study","Inclusion Criteria:\n\n* Participants must be determined to be a fructose malabsorber (screening visit) via hydrogen breath test.\n\nExclusion Criteria:\n\n* Use of probiotic\u002Fprebiotic\u002Fsynbiotic supplements\n* Consumption of \\> 1 sugar sweetened beverage per day\n* Antibiotics within 3 months prior to enrollment or during intervention\n* Vegetarian, vegan or other restrictive dietary habits\n* Food allergy\n* Alcohol consumption in excess of 2 drink per day\n\nThe following additional factors will be exclusion criteria:\n\n* Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder\n* Physical, mental, or cognitive handicaps that prevent participation\n* Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles;\n* Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs; e) restrictive dietary habits;\n* food allergy;\n* excess alcohol consumption;\n* recent use of pro-, pre- or Synbiotics of receipt of antibiotics within 3 months prior to enrollment or during the intervention;\n* consumption of greater than 1 sugar sweetened beverage per day prior to enrollment","25 Years","45 Years",{"count":355,"type":21},30,[24],"Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period.\n\nThe research team aims to:\n\n1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk.\n2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model.\n\nThe research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes.\n\nThe research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human participants in both the glucose and fructose arms of the clinical intervention will be transplanted into germ-free and colonized mice to establish a causal relationship between fructose-induced changes to the gut microbiome, liver fat and metabolic and inflammatory changes known to increase risk for T2D.\n\nThe research team aims to comprehensively assess the structural and functional changes to the gut microbiome brought about by a high fructose diet. Determining the impact of excess fructose on the microbiome will help identify novel means by which fructose contributes to metabolic disease risk. In addition to identifying strategies to improve metabolic health in adults, data from this proposal could help inform targeted approaches to mitigate future disease risk in vulnerable populations that consume high levels of fructose, such as children.",[33,359,27],"Type 2 Diabetes",[361,33,27,362,55],"Microbiome","Fructose","2025-12-15",{"date":365,"type":64},"2025-12-17",{"date":367,"type":64},"2024-10-08",{"date":369,"type":21},"2028-08-31",{"name":371,"class":71},"Icahn School of Medicine at Mount Sinai",{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":4},"100616416","improving-liver-fibrosis-diagnosis-in-primary-care-using-fibrox-ai-100616416","NCT07305324","Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI","Validation of an AI Tool for Improving MASLD Advanced Liver Fibrosis Diagnosis in Primary Care: A Provider-Level Crossover Randomized Controlled Trial Pilot","Inclusion Criteria:\n\n* Licensed primary care providers (MD, DO, NP, or PA)\n* Currently practicing in adult primary care (≥0.5 Full-Time Equivalent)\n* Affiliated with one of the participating clinics (academic, community, or Federally Qualified Health Center)\n* Willing and able to participate in simulated electronic health record (EHR)-based case reviews\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Providers not actively practicing in adult primary care\n* Providers with less than 0.5 FTE in clinical practice\n* Prior involvement in the development or validation of the FibroX tool\n* Inability to complete both simulation periods due to scheduling or other constraints",{"count":322,"type":21},[24],"The goal of this clinical trial is to learn whether an artificial intelligence (AI) tool called FibroX can help primary care providers better diagnose significant liver fibrosis (≥F2) and clinically significant portal hypertension in adults with metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nThe main questions it aims to answer are:\n\n* Can FibroX improve the accuracy of diagnosing significant liver fibrosis (≥F2) and clinically significant portal hypertension compared to usual care?\n* Is FibroX easy to use and acceptable to primary care providers in simulated clinical settings?\n* Do providers trust FibroX as a decision-support tool?\n\nResearchers will compare FibroX-assisted care to usual care to see if FibroX improves diagnostic accuracy, provider trust, and supports better decision-making.\n\nParticipants will:\n\n* Be primary care providers (MDs, DOs, NPs, PAs) from diverse clinics\n* Review simulated patient cases with MASLD risk factors\n* Use either usual care tools (standard labs and optional FIB-4 calculator) or FibroX (AI-generated risk score, triage band, and explainability panel)\n* Make diagnostic and referral decisions for each case\n* Complete surveys on usability, trust in AI, confidence, and cognitive workload\n\nThis study will help determine whether FibroX can be integrated into real-world primary care workflows to support earlier and more accurate detection of liver fibrosis and portal hypertension, potentially reducing missed diagnoses, unnecessary referrals, and improving patient outcomes.",[33,383],"Fibrosis of Liver",[31,385,386,387,388,389,390],"Advanced Liver Fibrosis","Primary Care Providers","Explainable AI","Provider-Level Crossover Trial","Simulation-Based Clinical Trial","Pilot Study","2025-12-12",{"date":393,"type":64},"2025-12-26",{"date":395,"type":21},"2026-06-15",{"date":397,"type":21},"2027-06-15",{"name":190,"class":71},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":135,"sex":17,"minAge":18,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":127},"100612094","definition-of-the-genomic-landscape-of-masld-100612094","NCT07249112","DEFINITION OF THE GENOMIC LANDSCAPE OF MASLD","DEFINIZIONE DEL PANORAMA GENOMICO DELLA MASLD (DEFINING THE GENOMIC LANDSCAPE OF METABOLIC STEATOTIC LIVER DISEASE)","Inclusion Criteria:\n\nSpecific Inclusion Criteria for Patients with Advanced MASLD:\n\n* Patients with advanced MASLD defined as liver fibrosis ≥2 and\u002For the development of HCC (Hepatocellular Carcinoma);\n* Patients enrolled in the context of the SERENA study and, where applicable, also in the context of the REASON study;\n* Liver biopsy for suspected Non-Alcoholic Steatohepatitis (NASH) at the time of diagnosis;\n* Cholecystectomies;\n* Age \\[40-70 years\\];\n* Patients who have signed the informed consent form.\n\nSpecific Inclusion Criteria for the Control Group:\n\nBlood donors participating in the Liver Bible study aged between 40 and 70 years who are overweight or obese and have at least two of the following risk factors:\n\n* Impaired fasting glucose or Diabetes Mellitus\n* Dyslipidemia\n* Arterial hypertension.\n\nExclusion Criteria:\n\nSpecific exclusion Criteria for Patients with Advanced MASLD:\n\n* Positivity for chronic viral hepatitis (HCV-RNA and\u002For HBsAg);\n* Positivity for other liver diseases such as autoimmune and viral hepatitis (Hepatitis B and C), hereditary hemochromatosis, alpha-1-antitrypsin deficiency, or Wilson's disease.\n\nSpecific Exclusion Criteria for the Control Group:\n\nSubjects with chronic degenerative diseases will be excluded, with the exception of well-controlled hypertension and Type 2 Diabetes Mellitus that does not require pharmacological therapy (as is already standard practice for blood donation eligibility). Also excluded are donors aged \\> 65 and \\\u003C 40 years.","90 Years",{"count":408,"type":21},2880,[24],"The Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a leading cause of chronic liver disease globally, with a prevalence exceeding 30% in the population. MASLD is strictly associated with insulin resistance and cardiometabolic conditions, and in 20-30% of cases, it can progress to steatohepatitis (MASH), which is characterized by progressive liver damage and inflammation. In patients at higher risk, the disease can lead to the onset of advanced fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). One of the main problems in the clinical management of MASLD is the absence of specific risk biomarkers and the lack of effective treatments, especially for patients with advanced-stage disease.\n\nMASLD has a well-documented and enormous genetic component, with studies having identified several common variants associated with this pathology, such as those in the PNPLA3, TM6SF2, and MBOAT7 genes. However, these variants identified so far only explain a small part of MASLD's heritability, suggesting the contribution of rare loss-of-function (LoF) variants as well. Furthermore, scientific evidence indicates that the accumulation of somatic variants, both in hepatocytes and myeloid cells, could also play a key role in MASLD progression. In particular, clonal hematopoiesis of indeterminate potential (CHIP), which is a condition characterized by the presence of hematopoietic clones with somatic mutations often associated with leukemia and cardiovascular diseases, might favor the onset of hepatocellular carcinoma. However, the evidence available to date is still limited and requires further investigation and studies on larger cohorts.\n\nThe current study therefore aims to deepen this aspect through the analysis of the genetic profile using a Whole-Genome Sequencing (WGS) approach. DNA samples from peripheral blood from patients with advanced MASLD and peripheral blood DNA samples from controls presenting various associated metabolic risk factors will be sequenced.\n\nIn addition, 80 liver tissue samples from patients with advanced MASLD will also be sequenced to identify specific somatic mutations. The expected results from this study include the identification of new genetic variants associated with MASLD progression, the improvement of risk stratification through the development of polygenic risk scores, and the identification of potential therapeutic targets. This study represents a fundamental step for understanding the biology of MASLD and could have important clinical implications for disease management.",[412,33],"Cirrhosis","2025-11-21",{"date":415,"type":64},"2025-11-25",{"date":417,"type":64},"2025-09-01",{"date":419,"type":21},"2026-08-31",{"name":421,"class":71},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":127},"100570332","chrononutrition-chronotoxicity-intervention-in-people-with-metabolic-associated-steatotic-liver-disease-100570332","NCT06705868","Chrononutrition\u002F Chronotoxicity Intervention in People With Metabolic-associated Steatotic Liver Disease.","Time-restricted Eating in Patients With Metabolic-associated Steatotic Liver Disease . CHRONOMASLD: A Chrononutrition\u002FChronotoxicity Randomized Controlled Trial.","CHRONOMASLD","Inclusion Criteria:\n\n1. Body mass index 25 (±0,5)-45(±0,5) kg\u002Fm2\n2. Clinical diagnosis of MASLD, not excluding undiagnosed NASH or with NASH stage F0-F1\n3. Self-reported habitual eating period more than or equal to 14 h per day, BUT NOT LESS.\n4. Cyprus inhabitants of for at least 1 year\n5. Registered to the National Health System of the Republic of Cyprus (Gesy\n\nExclusion Criteria:\n\n1. Night Shift worker\n2. Fasting \\>12-h\u002Fday more than once a week or \\> once a week no food intake after 18:00\n3. Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:\n\n   1. Positive hepatitis B surface antigen\n   2. Positive hepatitis C virus RNA\n   3. Suspicion of drug-induced liver disease\n   4. Alcoholic liver disease\n   5. Autoimmune hepatitis\n   6. Wilson's disease\n   7. Hemochromatosis\n   8. Primary biliary cholangitis or primary sclerosing cholangitis\n   9. Known or suspected hepatocellular carcinoma\n4. Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)\n5. Current or recent history (\\\u003C5 years) of significant alcohol intake (\\>30g of alcohol\u002F day or \\>210g\u002Fweek for men, \\>20g of alcohol\u002Fday or \\>140g\u002Fweek for women)\n6. Doctor diagnosed diabetes mellitus on insulin or sulfonylureas\n7. Severe medical comorbidities \\[ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \\>200\u002F120 mmHg)\\]\n8. Unstable weight (\\>5% change in the last 2 months) or participation in a weight-loss program within the past 12 weeks\n9. Sleep disorder (with a medical diagnosis) or individuals self-reporting sleep difficulties and poor sleep \\[average sleep less than 6 consecutive hours or patients who systematically experience sleep interruption for more than 2 times each night (waking up for toilet use is not to be considered sleep interruption)\\]\n10. Individuals with food allergies (or hypersensitivity to the fruits and vegetables that will be selected for the study)\n11. Systematic organic products consumers (defined as a self-reported usual consumption of more than 80% of their weekly fruits \\& vegetables being organic)\n12. Pregnant or trying to become pregnant or lactating women\n13. People not in position to communicate in Greek or English language\n14. Having metallic parts in the body.",{"count":431,"type":21},150,[24],"The goal of this clinical trial is to study the effect of a time-restricted eating (TRE) dietary pattern combined with a time of consumption restriction about the daily portions of fruits and vegetables in people diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nThe protocol of the study is an intention to treat protocol. The main research questions are:\n\n1. Does compliance in a TRE dietary scheme (positively) affect changes in body weight and body fat mass in people diagnosed with MASLD?\n2. Does an additional time restriction on the consumption of fruits and vegetables within the \"light-window\" of the day affects the metabolism of food contaminants?\n\nParticipants will be asked to:\n\n1. Adhere to a TRE dietary pattern for 3 months. TRE consists of an 8-hour eating vs 16 hours fasting within the day. First meal of the day should not occur at least an hour after wake-up time and last meal of the day should occur not later than 2 hours before bed-time.\n2. Adhere to a further time restricted consumption of a \"5-a-day\" portions of fruits and vegetables between the \"light-window hours\" between 9am to 4pm.\n3. Visit the Nutrition \\& Dietetics Clinic once every month for anthropometric measurements (on 4 time points).\n4. Collect and deliver first morning urine samples (on 7 time points).\n5. Collect and deliver saliva samples at baseline and at the end of the trial (Saliva collection should occur every 4-hours for 48-hours including fasting collection at baseline and at the end of three months)\n\n5\\) Complete a compliance and lifestyle questionnaire questionnaire via telephone interview to the research team every 2 weeks.\n\n6\\) Share photos to the research team with the use of an application on time of actual fruit and vegetables consumption, 3-4 times per week throughout the study protocol.\n\nResearchers will compare the designed intervention package of this TRE with the Standard of Care (SoC) protocol (based on the international guidelines) that is currently used in daily practice for the management of MASLD.",[33,297,170,435,252],"NAFLD - Non-Alcoholic Fatty Liver Disease",[437,438,439,440,441,442,33,31],"non alcoholic fatty liver disease (NAFLD)","chrononutrition","intermittent fasting","randomized controlled trial (RCT)","chronotoxicity","time restricted eating","2025-11-18",{"date":445,"type":64},"2025-11-19",{"date":447,"type":21},"2026-01-05",{"date":449,"type":21},"2029-12-15",{"name":451,"class":71},"Cyprus University of Technology",{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":135,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":127},"100567722","nafld-clinical-care-pathway-100567722","NCT06671886","NAFLD Clinical Care Pathway","Testing the Effectiveness of NAFLD Clinical Care Pathway in VA Primary Care","NCCP","Inclusion Criteria:\n\nPatient Aligned Care Teams (PACT) at the Michael E. DeBakey VA Medical Center\n\nExclusion Criteria:\n\n* The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization.\n* PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination.\n* PACTs meeting the following criteria will be excluded from randomization in Aim 2:\n\n  * PACTs who do not treat NAFLD,\n  * PACTs not located at the main hospital,\n  * PACTs with less than 100 visits within 3 months.",{"count":461,"type":21},32,[24],"Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD. Therefore, the burden of NAFLD and its complications among Veterans is substantial. However, most VA patients with NAFLD are undiagnosed and untreated, and their care is not consistent with practice guidelines. The NAFLD Clinical Care Pathway (NCCP) intervention seeks to close this major gap in the care of Veterans by automatically identifying patients at risk of NAFLD, calculating their risk scores of having severe NAFLD, and educating the primary care providers on the diagnosis and treatment of NAFLD. This clinical trial will test the benefit of this NCCP intervention against usual care in increasing the rates of NAFLD diagnosis as well as referral to and enrollment in appropriate treatment. The study will also identify barriers and promotors of future NCCP implementation.",[170,33],[170,466,467,33],"Veterans","Primary health care","2025-11-13",{"date":470,"type":64},"2025-11-14",{"date":472,"type":64},"2024-02-02",{"date":474,"type":21},"2028-11-13",{"name":476,"class":477},"VA Office of Research and Development","FED",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":72},"100561642","endoscopic-ultrasound-shear-wave-elastography-study-100561642","NCT06592820","Endoscopic Ultrasound Shear Wave Elastography Study","Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease","EUS-SWE","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Willing and able to provide informed consent\n3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n4. Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n5. BMI \\>\u002F=28\n6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and\u002For 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)\n\nExclusion Criteria:\n\n1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma\n2. Prior history of Hepatitis B or C infection\n3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)\n4. Histological evidence of other concomitant chronic liver disease on biopsy\n5. Inadequate liver biopsy\n6. Prior history of or current excess alcohol consumption (\\>140 g\u002Fweek and \\>210 g\u002Fweek for females and males, respectively) documented in EMR",{"count":487,"type":21},300,"This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\\[s\\] it aims to answer are:\n\n* Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis\n* Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).\n\nParticipants will undergo:\n\n* Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)\n* Liver biopsy\n* FibroScan",[33,34,490,491],"Fibrosis, Liver","Chronic Liver Disease",[493,494,495,496],"Shear Wave Elastography","Shear Wave","FibroScan","Attenuation Imaging","2025-09-11",{"date":499,"type":64},"2025-09-15",{"date":501,"type":64},"2025-09-03",{"date":503,"type":21},"2027-03-28",{"name":505,"class":506},"Olympus Corporation of the Americas","INDUSTRY",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":521,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":538,"locationsCount":540},"100566936","evaluation-of-a-new-ultrasound-system-for-the-non-invasive-assessment-of-liver-steatosis-in-masldmash-patients-100566936","NCT06661655","Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD\u002FMASH Patients","ACOUSTIQ","Inclusion Criteria:\n\n* Adult patient below 80 yo\n* Patients with MASLD\u002FMASH recruited in interventional trials requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients with MASLD\u002FMASH recruited in prospective cohorts requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients referred to MRI-PDFF or MRE.\n* Patients who consented in written to participate in the study\n* Patients with ongoing social security coverage\n\nExclusion Criteria:\n\n* Patient in their minority (less than 18 yo) or older than 80 yo,\n* Patient with active implants,\n* Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)\n* Patient with a history of decompensated cirrhosis,\n* Patient with a history of hepatocellular carcinoma,\n* Adult patient under tutorship, or unable to express informed consent,\n* Pregnant or breast-feeding\n* Person deprived from their liberty\n* Patient hospitalized without providing consent or in case of an emergency\n* Patient presenting with another know liver disease",{"count":138,"type":21},[24],"The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.",[518,55,171,33,519,520,170],"Metabolic Syndrome X","NASH (Non-Alcoholic Steatohepatitis)","Steatosis, Liver",[522,523,524,525,526,527,528,529,530,531],"Liver","Fibrosis","Steatosis","Elastography","Ultrasound","Attenuation","Backscattering coefficient","Sound speed","MRI PDFF","Hepatoscope","2025-08-12",{"date":534,"type":64},"2025-08-15",{"date":536,"type":64},"2025-07-24",{"date":93,"type":21},{"name":539,"class":506},"E-Scopics",3,{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":135,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":552,"conditions":553,"keywords":558,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":540},"100600119","the-impact-of-pectin-supplementation-on-systematic-inflammation-pathway-gut-microbiome-and-metabolic-health-in-patients-with-metabolic-dysfunction-associated-steatotic-liver-disease-masld-100600119","NCT07093346","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomised, Placebo-Controlled, Dietary Intervention Study","PEC-MASLD","Inclusion Criteria:\n\nInclusion criteria for the main study:\n\n* Patients with clinical diagnosis of MASLD (formerly termed non-alcoholic fatty liver disease (NAFLD)), having assessment suggesting that liver fat \\> 5% (e.g. histological evidence or\u002F and Transient Elastography using Controlled Attenuation Parameter (CAP)- FibroScan™ in the past month and\u002For liver imaging (such as ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI)).\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years who have a body mass index (BMI) between 18.5 and 39.9 kg\u002Fm2 and stable weight (weight gain or loss ≤ 3kg) for the past 3 months.\n* For diabetic participants: controlled blood glucose levels Haemoglobin A1C (HbA1c) \\\u003C7.0% (\\\u003C53 mmol\u002Fmol) \\[1\\].\n* Able to undergo CAP-FibroScan™.\n\nInclusion criteria for healthy participants who will have MRI scans:\n\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years.\n* participants with CAP\\\u003C250 kpa\\\u003C8kP by a FibroScan™ within the past 6 months.\n\nExclusion Criteria:\n\nExclusion criteria for the main study:\n\n* Have allergy toward soya, milk or chocolate.\n* Have allergy toward pectin.\n* Participants on vegan diet.\n* Have eating disorders or difficulties or gastrointestinal conditions e.g. malabsorptive conditions such as coeliac, Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) or gastroparesis.\n* Have chronic malnutrition condition.\n* History of major surgery which potentially limits participation or completion of the study.\n* History of previous intestinal surgery known to affect food intake or digestive function, including bariatric surgery.\n* Use of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.\n* Are taking the following medications: immunosuppressants, amiodarone and\u002For perhexiline.\n* Are currently following or anticipated to commence a specialised commercially available weight loss diet and\u002For program or concomitant use of any weight loss medication or herbal weight loss products.\n* History of side effects towards probiotics or prebiotics.\n* History or current psychiatric illness.\n* History or current neurological condition (e.g. epilepsy).\n* Participants with other liver abnormalities.\n* Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.\n* Have had a weight change exceeding 3 kg within 3 months.\n* Uncontrolled diabetes, active malignancy, or chronic infections.\n* Having symptoms of active infection.\n* Excessive alcohol intake defined as self-reported intakes greater than 21 units per week in men, and 14 units per week in women.\n* Participants who are pregnant, breast feeding or actively planning pregnancy will be excluded from the study.\n* Participation in any other trial in the last 3 months.\n\nExclusion criteria for healthy volunteers MRI scans and patients optional MRI scans:\n\n* Contraindications for MRI scanning: having pacemakers, defibrillators, neurostimulators, prohibited medical implants, and foreign bodies (e.g. bullets, shrapnel, metal slivers), history of metallic foreign body in eye(s) and penetrating eye injury that could present a risk during an MRI scan.\n* Difficulty breathing or inability to lie flat, as well as conditions that could worsen under stress (such as anxiety or panic disorders, claustrophobia, uncontrolled hypertension, or seizure disorders) severe enough to prevent undergoing an MRI.",{"count":550,"type":21},45,[24],"The goal of this clinical trial is to learn if daily supplementation with Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), can reduce systemic inflammation and improve gut microbiota composition in adults recently diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The main question it aims to answer is:\n\n-How does dietary Low-methoxy (LM) pectin supplementation affect systematic inflammation pathways such as those mediated by gut microbiota composition and what are the impacts on general metabolic indicators in individuals with MASLD?\n\nResearchers will compare a group taking 15g of LM-pectin with 10g of cocoa powder to a placebo group receiving 10g of placebo with 10g of cocoa powder to see if LM-pectin has measurable effects on inflammation and gut microbiota.\n\nParticipants will:\n\n* Take a daily supplement for 6 weeks: either 15g of LM-pectin with 10g of cocoa powder (intervention), or 10g of placebo with 10g of cocoa powder (control)\n* Provide stool and fasting blood samples before and after the intervention\n* Undergo anthropometric measurements (weight, height, waist\u002Fhip ratio, and blood pressure)\n* Complete a case report form (CRF) including demographics and health\u002Fmedical history\n* Undergo a FibroScan™ to assess liver health\n* (Optional) Participate in MRI scans to evaluate gut permeability",[554,555,297,33,170,31,252,556,435,557],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Fatty Liver Disease (NAFLD)","NAFLD (Non-alcoholic Fatty Liver Disease)","NAFLD - Nonalcoholic Fatty Liver Disease",[559,560,33,170,554,561,562,563,564,565,31],"LM pectin","pectin","Systemic Inflammatory Response","Dietary Fiber","Dietary Fibre","Diet","gut microbiota","2025-07-22",{"date":568,"type":64},"2025-07-30",{"date":570,"type":64},"2025-06-10",{"date":572,"type":21},"2027-03-31",{"name":574,"class":71},"University of Nottingham",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":33,"eligibilityCriteria":581,"healthyVolunteers":135,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":582,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":584,"conditions":585,"keywords":588,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":127},"100429529","development-of-a-non-invasive-screening-tool-to-predict-metabolic-dysfunction-associated-steatotic-liver-disease-100429529","NCT04873258","Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease","Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Volunteers on Clinical Trials Utilising Machine-learning and Bioimpedance Vector Analysis","Inclusion Criteria:\n\n1. Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.\n2. Willingness and ability to provide written, personally signed, and dated informed consent, in accordance with the latest ICH Good Clinical Practice (GCP) Guidelines and applicable regulations.\n3. An understanding, ability and willingness to fully comply with project procedures and restrictions.\n\nFor PART B only:\n\n1\\. With a known history of MASLD as evidenced either of:\n\n1. GP diagnosis on HCF\n2. Documented Fibroscan or liver US demonstrating MASLD\n\nExclusion Criteria:\n\n1. Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)\n2. Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)\n3. Alcohol consumption \\>30 units per week\n4. An Implanted cardiac devices",{"count":583,"type":21},2000,"A generic screening study to establish structural and\u002For functional baselines of specific organs.",[586,55,33,297,587],"Healthy","Obesity and Obesity-related Medical Conditions",[589,33],"Fatty liver","2025-07-18",{"date":592,"type":64},"2025-07-23",{"date":594,"type":64},"2019-09-27",{"date":596,"type":21},"2027-12-31",{"name":598,"class":506},"Richmond Research Institute",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":606,"targetDuration":4,"studyType":22,"phases":608,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":127},"100587919","early-phase-1-effect-of-tirzepatide-on-markers-of-masld-in-patients-with-obesity-100587919","NCT06934642","Effect of Tirzepatide on Markers of MASLD in Patients With Obesity","Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study","Inclusion Criteria:\n\n* Men and women\n* Age 18-75\n* Diagnosis of MASLD based on the following criteria:\n\n  * Presence of at least 1 out of the 5 following cardiometabolic criteria:\n* BMI \\>25 kg\u002Fm2 OR waist circumference \\>94 cm (men) or 80cm (women)\n* Fasting serum glucose \\>100 mg\u002FdL OR 2-hour post-prandial glucose levels \\>140mg\u002FdL OR AbA1c \\>5.7% OR type 2 diabetes OR treatment for type 2 diabetes\n* Blood pressure \\>130\u002F85 mmHg OR specific antihypertensive drug treatment\n* Plasma triglycerides \\>150mg\u002FdL OR on lipid lowering treatment\n* Plasma HDL-cholesterol \\\u003C40mg\u002FdL (men) and \\\u003C50mg\u002FdL (women) OR on lipid lowering medication\n\n  * No other identified causes of steatosis\n  * Evidence of steatotic liver disease (hepatic steatosis identified by imaging or biopsy)\n* English speaking\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Premenopausal women not on any form of contraception\n* Reports alcohol intake \\>50g\u002Fday or 350g\u002Fweek for women and \\>60g\u002Fday or 420g\u002Fweek for men or an AUDIT score \\>8\n* Other identifiable causes of steatosis\n* Documented allergic reaction to tirzepatide or any other GLP1 RA\n* Decompensated liver disease\n* Decompensated renal disease requiring hemodialysis\n* Decompensated heart failure\n* Active malignancy\n* Prior history of pancreatitis\n* Serum triglyceride levels \\>500 mg\u002FdL\n* Personal or family history of medullary thyroid cancer or MEN2a or MEN2b\n* Concurrent use of other ant-obesity medications\n* Use of other GLP1 RAs within 3 months of study enrollment\n* Unable to obtain the medication due to cost or insurance coverage restrictions.",{"count":607,"type":21},8,[609],"EARLY_PHASE1","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD.\n\nParticipants will be asked to:\n\n* Take tirzepatide for 12 months.\n* Come in for clinic visits every 3 months.\n* Have blood drawn at baseline, 6, and 12 months.\n* Complete a liver ultrasound at baseline and at 12 months.",[33,27],"2025-07-10",{"date":614,"type":64},"2025-07-14",{"date":616,"type":64},"2025-06-30",{"date":618,"type":21},"2026-08",{"name":620,"class":71},"University of New Mexico",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":630,"conditions":631,"keywords":637,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":127},"100598351","digital-early-warning-system-for-acute-lung-injury-in-liver-surgery-100598351","NCT07070362","Digital Early Warning System for Acute Lung Injury in Liver Surgery","The Construction of a Digital Intelligence Early Warning System for the Whole Process of Acute Lung Injury in Liver Surgery Based on Cardiopulmonary Interaction Characteristics","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing major liver surgery (including two-segment or more hepatectomy, liver transplantation, etc.)\n* Voluntary participation with signed informed consent",{"count":629,"type":21},4000,"This study focuses on developing an explainable machine learning model based on cardiopulmonary interaction characteristics to achieve early prediction of acute lung injury (ALI) in patients undergoing major liver surgery. The research will establish a digital early-warning system for ALI to provide support for clinical diagnosis and treatment decisions, thereby reducing the incidence and fatality rate of ALI.",[632,633,634,33,635,252,636],"Acute Lung Injury(ALI)","Liver Cirrhosis","ARDS, Human","MASLD\u002FMASH (Metabolic Dysfunction-Associated Steatotic Liver Disease \u002F Metabolic Dysfunction-Associated Steatohepatitis)","Liver Cancer, Adult",[638,639,640,641,642],"Digital Intelligence","Acute Lung Injury","PPCs","Liver Surgery","Cardiopulmonary Interaction;","2025-07-08",{"date":645,"type":64},"2025-07-17",{"date":647,"type":64},"2024-11-01",{"date":649,"type":21},"2027-11-30",{"name":651,"class":71},"Beijing Tsinghua Chang Gung Hospital",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":17,"minAge":660,"maxAge":136,"enrollmentInfo":661,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":669,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":127},"100570032","effects-of-a-healthy-nordic-diet-on-atherosclerosis-in-patients-with-coronary-heart-disease-100570032","NCT06701968","Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease","A Healthy Nordic Diet to Reduce the Progression of Atherosclerosis in Individuals with Coronary Heart Disease: a Secondary Prevention Trial","NORDHEART","Inclusion Criteria:\n\n* Men and women\n* Diagnosis with MI from 2 weeks after diagnosis and with maximum 6 months after diagnosis\n* Diagnosis with CCS (e.g. stable angina pectoris)\n* Ages 50 to 80 years\n* BMI 25-40.\n\nExclusion Criteria:\n\n* Severe heart failure (NYHA classes III, IV)\n* Alcohol intake \\>20g\u002Fday\n* Unwillingness to follow a new prescribed diet for 18 months\n* Other diseases implying a short estimated life expectancy (e.g. severe malignant or kidney or liver disease, as judged by consenting physician).","50 Years",{"count":431,"type":21},[24],"Diet can play a key role in atherosclerosis and coronary heart disease (CHD), but little interventional data exists, and the mediators of possible anti-atherosclerotic effects of diet are unclear. The investigators will investigate if a healthy Nordic diet (HND) reduces plaque volume, coronary artery calcification (CAC), and plaque inflammation (FAI) in CHD, and examine if changes in gut microbiota may be linked to plaque progression over time. The investigators will also explore if the diet response can be predicted by the metabolic phenotype.\n\nIn total 150 CHD patients is randomized to a HND rich in unsaturated fat and fibre from plants, or to a \"usual care diet\" for 18 months. Plaque volume and composition is assessed by CT, and fecal microbiota composition is determined by deep metagenome shotgun sequencing. CHD and metabolic risk factors, liver fat, muscle fat and biomarkers of diet adherence (plasma fatty acids, whole-grain metabolites) are measured. Machine-learning is used to identify diet \"responders\" on plaque progression, based on the individual microbiome and metabolome.\n\nIf a HND reduces plaque progression, this would be novel information of clinical importance. Also, if the diet alters microbiota that are linked to plaque progression, this would be of high scientific interest. Finally, potential prediction of the diet-response would open up for more personalized treatment of atherosclerosis.",[665,666,667,668,33,359],"Coronary Disease","Coronary Arteriosclerosis","Myocardial Infarction","Chronic Coronary Syndrome",[564,670,671,672,673,674,675,676,677,170],"Secondary prevention","Coronary plaque regression","Atherosclerosis","Type 2 diabetes","Coronary heart disease","Myocardial infarction","Coronary computed tomography angiography","Healthy nordic diet","2025-03-05",{"date":680,"type":64},"2025-03-06",{"date":682,"type":21},"2025-03-20",{"date":684,"type":21},"2031-12-30",{"name":686,"class":71},"Uppsala University",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":693,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":695,"enrollmentInfo":696,"targetDuration":4,"studyType":22,"phases":698,"briefSummary":699,"conditions":700,"keywords":705,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":715,"locationsCount":127},"100578722","acquisition-of-cardiac-function-parameters-in-mri-and-echocardiography-in-patients-with-ethyltoxic-liver-cirrhosis-and-transjugular-intrahepatic-portosystemic-shunt-tipss-placement-100578722","NCT06814990","Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients with Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement","Erfassung Kardialer Funktionsparameter in MRT Und Echokardiographie Bei Patienten Mit Ethyltoxischer Leberzirrhose Und Transjugulärer Intrahepatischer Portosystemischer Shunt (TIPSS)-Anlage","EVALUATION","Inclusion Criteria:\n\n* Age 18 to 99 years\n* Written informed consent of the patient\n* Decompensated liver cirrhosis, defined by clinical, imaging or laboratory criteria\n* Patient receives an elective TIPSS in the appropriate clinical context at the JUH\n\nExclusion Criteria:\n\n* Pregnancy\n* Implants not suitable for magnetic resonance imaging\n* Medical\u002Fpersonal reasons against magnetic resonance imaging (claustrophobia, patient cannot lie flat or follow breathing commands)\n* Patient in critical condition or incompliant","99 Years",{"count":697,"type":21},80,[24],"The aim of this clinical trial is to investigate the development of cardiac decompensation following transjugular intrahepatic portosystemic shunt (TIPSS) implantation in order to draw conclusions for future treatment methods or exclusion criteria prior to TIPS implantation.\n\nThe main questions to be answered are:\n\nHow often do symptoms of cardiac decompensation develop over a one year period? What laboratory, clinical or imaging morphological changes are associated with this? In addition to the standardised clinical procedure for TIPSS implantation, participants will undergo 3 cardiac magnetic resonance imaging (MRI), extended echocardiographic examinations (both just before, 3 days after and 3 months after implantation) and laboratory chemistry tests for specific endothelial and inflammatory markers (just before, on the day of implantation, 1 day after, 1, 3, 6 and 12 months after implantation).",[33,701,702,703,704],"Liver Cirrhosis, Alcoholic","Cirrhosis of Liver","Heart Decompensation","TIPS",[706,707,704],"Chirrotic cardiomyopathy","Liver chirrosis","2025-02-11",{"date":710,"type":64},"2025-02-13",{"date":712,"type":64},"2024-04-19",{"date":714,"type":21},"2027-04-19",{"name":716,"class":71},"Stephanie Gräger",{"id":718,"slug":719,"hasResults":12,"nctId":720,"briefTitle":721,"officialTitle":722,"acronym":723,"eligibilityCriteria":724,"healthyVolunteers":135,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":725,"targetDuration":4,"studyType":22,"phases":727,"briefSummary":728,"conditions":729,"keywords":730,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":732,"lastUpdatePostDateStruct":733,"startDateStruct":735,"completionDateStruct":737,"leadSponsor":739,"locationsCount":127},"100557544","phase-2-luminal-fructose-kinetics-martini-study-100557544","NCT06539494","Luminal Fructose Kinetics (MARTINI Study)","Luminal Fructose Kinetics (MARTINI) (2024)","MARTINI","Inclusion Criteria:\n\nIn case of the healthy subject group:\n\n* Adult individuals, age \\> 18 \\\u003C65 years\n* Male or postmenopauzal females\n* BMI \\\u003C25\n* Ability to give informed consent In case of the MASLD\u002FMASH group\n* Adult individuals, age \\> 18 \\\u003C65 years\n* Male or postmenopauzal females\n* BMI \\> 25\n* Biopsy proven MASLD\u002FMASH\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* History of sustained excess alcohol ingestion: daily consumption \\>30g\u002Fday (3 drinks per day) for males and \\>20 g\u002Fday (2 drinks per day) for females\n* Patients with diabetes\n* Bariatric surgery\n* Other forms of liver disease (e.g. Hepatitis B,C, Wilson disease, hemochromatosis)\n* Proton-pump inhibitor usage one year prior to study participation\n* GLP1, SGLT2i or insulin use\n* Antibiotic use for the past 3 months\n* Probiotic or symbiotic usage\n* Pregnant women\n* Chronic illness (including a known history of heart failure, renal failure (eGFR \\\u003C30 ml\u002Fmin), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases\n* Active infection\n* Use of ascal, clopidogrel or other platelet inhibition\n* Smoking\n* Blood thinners\n* Heart failure",{"count":726,"type":21},22,[166],"In this study the investigators aim is to explore the dynamics of (small) intestinal fructose catabolism in humans and ethanol production in relation to small intestinal signalling pathways and changes in pH, using 13C fructose isotope tracing techniques complemented with direct luminal sampling via small intestinal catheter in biopsy proven MASLD\u002FMASH patients vs healthy (BMI\\\u003C25) subjects. Additionally the investigators will repeat the experiment after four weeks of administering omeprazole at a dose of 40 mg twice daily. Omeprazole is a proton pump inhibitor, known to elevate pH from 2-6.",[33],[362,33,731],"Ethanol","2024-08-01",{"date":734,"type":64},"2024-08-06",{"date":736,"type":64},"2024-07-01",{"date":738,"type":21},"2026-04",{"name":344,"class":71}]