[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nonalcoholic-steatohepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nonalcoholic-steatohepatitis":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,65,101,129,166,191,222,245],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100464686","screening-and-follow-up-in-patients-with-hiv-infection-combined-with-metabolic-associated-fatty-liver-disease-100464686",false,"NCT05330923","Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease","Inclusion Criteria:\n\n* Newly treated or treated AIDS patients;\n* Regular follow-up visits to the hospital, medication compliance is good;\n* Patients or their family members were willing to participate in the study by understanding the study plan and providing written informed consent.\n\nExclusion Criteria:\n\n* Unable to complete the position requirements of ultrasonic examination (lying flat) due to mobility difficulties;\n* Patients have poor compliance and cannot follow up regularly or take medicine on time;\n* Patients or family members cannot understand the conditions and objectives of the study;\n* Other conditions considered unsuitable for inclusion by the investigator.","ALL",{"count":17,"type":18},2000,"ESTIMATED","OBSERVATIONAL","Acquired immunodeficiency syndrome (AIDS) remains a severe global infectious disease, with over 38 million people living with HIV and around 35 million cumulative deaths worldwide by 2023; approximately 1.24 million HIV-positive individuals and 100,000 new infections are reported annually in China. Widespread use of HAART has prolonged HIV patients' survival and reduced AIDS-related mortality, yet non-AIDS comorbidities dominated by chronic liver disorders, particularly metabolic dysfunction-associated fatty liver disease (MAFLD), have become a major challenge in long-term HIV management. Triggered by elevated blood lipids from lifestyle, antiretroviral agents and inherited metabolic factors, MAFLD initiates with hepatic steatosis and may progress to NASH, liver fibrosis, cirrhosis and even hepatocellular carcinoma (HCC) without timely intervention. HIV-positive patients develop more severe MAFLD progression than HIV-negative counterparts; existing biopsy data shows 91% of ART-treated HIV patients have NAFLD, among whom 65% suffer from NASH complicated with liver fibrosis.\n\nFatty liver prevalence keeps rising with younger onset age in China, which highlights the necessity of early screening. Liver biopsy, the historical diagnostic gold standard for liver injury grading, is restricted by invasiveness, bleeding risks and poor reproducibility. Transient elastography (TE), a novel non-invasive ultrasonic technique, quantifies hepatic steatosis via the ultrasound attenuation parameter (UAP) and liver fibrosis via liver stiffness measurement (LSM), and has been validated and guideline-endorsed for multiple chronic liver diseases globally. Published foreign data report 35%, 42% and 22% prevalence of NAFLD, NASH and fibrosis in PLWH, while domestic evidence on HIV-associated MAFLD is limited, especially liver-related discrepancies among varied ART regimens. With the implementation of China's new medical insurance policy, numerous patients are shifting from non-INI regimens to once-daily single-tablet INSTI STR regimens, whose hepatic and lipid impacts remain unclear. This study targets early detection of HIV patients with concomitant fatty liver to optimize management strategies and improve clinical outcomes.\n\nOur preliminary cohort at Peking Union Medical College Hospital included 188 virologically suppressed HIV patients on ART, 56.9% (107\u002F188) of whom developed fatty liver (mild:27.1%, moderate:19.7%, severe:10.1%). Liver fibrosis (LSM≥7.3 kPa) was found in 12.8% (24\u002F188) subjects, with 1.1% having advanced cirrhosis, and no significant inter-group difference in fatty liver incidence was noted between INSTI and NNRTI recipients. These findings lay a foundation for early diagnosis and follow-up intervention of metabolic liver disease among HIV-infected populations.",[22,23,24,25],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Steatohepatitis","Fibrosis","HIV\u002FAIDS",[27,28,29,30],"integrase inhibitors","non-nucleoside reverse transcriptase inhibitors","transient elastography","iLivTouch","RECRUITING","2026-06-02",{"date":34,"type":35},"2026-06-04","ACTUAL",{"date":37,"type":35},"2022-01-01",{"date":39,"type":18},"2029-06-01",{"name":41,"class":42},"Peking Union Medical College Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100494629","predicting-outcomes-in-nonalcoholic-steatohepatitis-with-advanced-fibrosis-100494629","NCT05720663","Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis","Inclusion Criteria:\n\nAdult patients with presence of NAFLD associated cirrhosis.\n\n* Cirrhosis: biopsy confirmed or Agile F (F4) score \\> 0.45\n* NAFLD as an etiology of liver disease will be determined based on presence of any of the following:\n\n  * Biopsy showing \\>5% steatosis or\n  * CAP \\> 280 dB\u002Fm or MR-PDFF\\>5%\n  * If CAP \\\u003C 280 dB\u002Fm or MR-PDFF \\\u003C5%, then must have type 2 diabetes and or 2 or more features of metabolic syndrome for 5 years (cryptogenic cirrhosis)\n\nExclusion Criteria:\n\n* Refusal to consent\n* Alcohol use \\> 14\u002F21 gm\u002Fweek cutoff\n* Other causes of chronic liver disease\n* MELD \\> 12\n* Hepatic and extrahepatic cancers expected to limit life expectancy \\\u003C 2 yrs\n* prior hepatic resections, TIPS, splenic embolization\n* prior decompensation events\n* inability to fit into MRI (failed hula-hoop test)\n* general contraindication for MRI contrast (GFR \\\u003C 30 ml\u002Fmin)\n* contraindications for MRI\n* pregnancy\n* acute kidney injury\n* reduced kidney function (GFR \\\u003C30ml\u002Fmin)","18 Years",{"count":52,"type":18},240,"Nonalcoholic Steatohepatitis (NASH) is a condition with increased amount of fat, inflammation and scarring in the liver. In compensated cirrhosis, the liver is coping with this damage and maintaining its important functions. Decompensation occurs when the liver becomes unable to perform all of its functions adequately. Variceal hemorrhage (bleeding from abnormal vessels in the liver called varices), Ascites (abnormal build-up of fluid in the abdomen), and Encephalopathy (brain confusion as a result of the liver not being able to get rid of toxic substances) are three symptoms of liver decompensation.\n\nThe purpose of this research study is to investigate better ways to routinely monitor the condition of patients with NASH with compensated cirrhosis and to better pinpoint the development of decompensation in the livers of these patients.",[23],"2026-04-01",{"date":57,"type":35},"2026-04-02",{"date":59,"type":35},"2023-04-19",{"date":61,"type":18},"2027-12",{"name":63,"class":42},"Virginia Commonwealth University",2,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":43},"100629981","phase-2-tesamorelin-for-reduction-of-liver-fat-in-adults-with-fatty-liver-disease-mock-study-100629981","NCT07481734","Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)","A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)","TESA-LIVER","Inclusion Criteria:\n\n* Adults age 18 to 75 years, able to provide informed consent.\n* Evidence of hepatic steatosis consistent with MASLD\u002FNAFLD, defined as MRI-PDFF \\>=10% at screening (or equivalent imaging documentation if MRI-PDFF was performed within the prior 8 weeks).\n* Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension).\n* Stable body weight (+\u002F-5%) for at least 3 months prior to screening.\n* If on diabetes, lipid-lowering, antihypertensive, or weight-loss medications, regimen is stable for at least 3 months prior to screening and expected to remain stable through week 52.\n* Willingness and ability to self-administer daily subcutaneous injections (or have a trained caregiver).\n* For participants of childbearing potential: agreement to use reliable contraception during treatment and for 30 days after the last dose; negative pregnancy test at screening and baseline.\n\nExclusion Criteria:\n\n* Significant alcohol consumption consistent with alcohol-associated liver disease (e.g., \\>20 g\u002Fday for women or \\>30 g\u002Fday for men for sustained periods).\n* Other chronic liver diseases (e.g., chronic hepatitis B, chronic hepatitis C with viremia, autoimmune hepatitis, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency).\n* Known cirrhosis or decompensated liver disease; or biopsy-proven stage 4 fibrosis if baseline biopsy is performed.\n* Poorly controlled diabetes or conditions increasing ocular risk (e.g., HbA1c at or above a protocol threshold; active\u002Funtreated diabetic retinopathy).\n* Use of exogenous growth hormone or GHRH analogs within the past 12 months.\n* Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate).\n* Active malignancy or high risk for recurrence judged unsafe by investigators.\n* Contraindications to MRI (e.g., certain implanted devices) if MRI-PDFF is required.\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to tesamorelin or formulation excipients (e.g., mannitol).\n* Bariatric surgery within the last 12 months, or planned bariatric surgery during the study period.","75 Years",{"count":75,"type":18},120,"INTERVENTIONAL",[78],"PHASE2","This randomized, double-blind, placebo-controlled Phase II study evaluates whether daily subcutaneous tesamorelin (a growth hormone-releasing hormone analog) reduces liver fat in adults with fatty liver disease. Participants receive tesamorelin or matching placebo for 52 weeks, with standardized lifestyle counseling in both groups. Liver fat is quantified by MRI-proton density fat fraction (MRI-PDFF). Key safety monitoring includes glucose metrics and IGF-1.",[81,23,82],"Metabolic Associated Steatotic Liver Disease","Hepatic Steatosis",[84,85,86,87,88,29,89,90],"Tesamorelin","GHRH analog","growth hormone axis","hepatic fat fraction","MRI-PDFF","teatohepatitis","fibrosis","2026-03-14",{"date":93,"type":35},"2026-03-19",{"date":95,"type":35},"2026-02-02",{"date":97,"type":18},"2028-02-17",{"name":99,"class":100},"Hudson Biotech","INDUSTRY",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":73,"enrollmentInfo":108,"targetDuration":4,"studyType":76,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":43},"100479681","phase-2-thyroid-hormone-for-treatment-of-nonalcoholic-steatohepatitis-in-veterans-100479681","NCT05526144","Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans","Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n* Men and women (pre- and post-menopausal)\n* Overweight\u002Fobese subjects with body mass index (BMI) at or above 25.9 kg\u002Fm2\n* Alcohol intake \\\u003C 20 grams per day\n* Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment\n* Patients who are treated with vitamin E or pioglitazone should be on stable doses for at least 6 months before enrollment\n* Features of metabolic syndrome: 3 or more (central obesity, hypertension, low HDL, high triglycerides, high fasting glucose)\n* Scheduled for a medically indicated, diagnostic liver biopsy\n* Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if they are not of child-bearing potential (i.e., surgically \\[bilateral oophorectomy, hysterectomy, or tubal ligation\\] or naturally sterile \\[\\> 12 consecutive months without menses\\])\n\n  * Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable for at least 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration\n  * Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice\n* If a patient is on digitalis and amiodarone, he\u002Fshe is expected to use\u002Fcontinue these medications throughout the treatment period only after consultation with their cardiologist for monitoring and dose adjustments if necessary\n\nExclusion Criteria:\n\n* Other causes of hepatitis including hepatitis B \\& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis\n* Alcohol consumption of 20 g\u002Fd or more\n* Patients with cirrhosis, bilirubin of 1.3 mg\u002FdL or more, and INR of 1.3 or more\n* Evidence of Portal hypertension\n* Pregnancy\n* History of malignant hypertension\n* Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \\> 160 mm Hg or a diastolic blood pressure \\> 100 mm Hg at screening\n* New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \\\u003C 30%\n* Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula (QTcF) \\> 450 msec for males and \\> 470 msec for females at the screening electrocardiogram (ECG) assessment\n* History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within at least 3 months prior to randomization\n* History of high degree AV block (Mobitz II or complete) in the absence of a pacemaker\n* Patients with uncorrected adrenal insufficiency\n* Patients who are on tricyclic or tetracyclic antidepressants or ketamine, if they are unwilling and\u002For unable to discontinue these medications to allow adequate washout prior to randomization\n* Patients who are on Teduglutide or Midodrine",{"count":109,"type":18},128,[78],"Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.",[23,113],"Liver Fibrosis",[115,116,117,118],"Thyroid hormone","Nonalcoholic fatty liver disease (NAFLD)","Nonalcoholic steatohepatitis (NASH)","Mitochondrial fatty acid oxidation","2026-02-17",{"date":121,"type":35},"2026-02-19",{"date":123,"type":35},"2023-04-01",{"date":125,"type":18},"2029-12-31",{"name":127,"class":128},"VA Office of Research and Development","FED",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":15,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":76,"phases":141,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":43},"100280677","bariatric-embolization-of-arteries-for-the-treatment-of-nonalcoholic-steatohepatitis-100280677","NCT02933554","Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis","A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization, to Promote Short-term Weight Loss in Obese Patients With Nonalcoholic Steatohepatitis (NASH) and Thereby Improve NASH","Inclusion Criteria:\n\n1. Male or Female, aged 22 years or older.\n2. Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study\n3. BMI \\>35 kg\u002Fm2\n4. Adequate hematological, hepatic and renal function as follows:\n\n   1. Hematological: Hematological: If the bariatric embolization procedure is being performed by femoral access: platelets \\> 50 x 109\u002FL, INR \\\u003C1.5. If the bariatric embolization procedure is being performed by radial access: platelets \\>35 x 109\u002FL and INR \\\u003C1.5 OR platelets \\>50 x 109\u002FL and INR between 1.5 and 2.\"\n   2. Hepatic : Total bilirubin \\\u003C3 mg\u002FdL\n   3. Renal: Estimated GFR \\> 60ml\u002Fmin.1.73m2\n5. If Center for Epidemiological Studies Depression (CESD) score \\> or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.\n6. Elevated alanine or aspartate aminotransferase values (ALT \\>41 or AST\\>34 U\u002FL).\n7. Liver biopsy showing evidence of NASH in the past 12 months.\n8. No evidence of another form of liver disease.\n9. Patients diagnosed with NASH and have evidence of failing other methods of weight loss through diet, exercise and behavior modification.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Active substance abuse\n3. Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score \\> or = 16 without psychiatric evaluation. \\[If Center for Epidemiological Studies Depression (CESD) score \\> or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.\\]\n4. Significant alcohol consumption ( \\>20 g\u002Fday in women, \\>30 g\u002Fday in men)\n5. Weight \\> 400 lbs, BMI \\> 50 kg\u002Fm2.\n6. Contraindications to obtaining a liver biopsy\n7. Subjects with pre-existing abdominal pain will be excluded (because of the potential confusion with pain related to the procedure).\n8. Subjects who are intolerant to PPIs\n9. Subjects requiring any anticoagulant medications should be excluded if radial access cannot be obtained.\n10. Subjects with platelets \\\u003C35 x 109\u002FL and INR \\> 2.0\n11. Subjects who are taking aspirin\u002F NSAIDs and in whom these medications are unable to be withdrawn from aspirin and NSAIDs for at least 3 days prior to the LGAE procedure and for 30 days following the LGAE procedure (because of the potential risks of gastric bleeding following the procedure).\n12. Presence of systemic illness or other medical conditions relevant to survival .(Note that in the HCC pre liver transplant cohort, the presence of HCC will not be considered an exclusion criteria)\n13. Metastatic cancer\n14. Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy)\n15. prior surgical weight loss procedures including gastroplasty, jejunoileal, or jejunocolic bypass, total parenteral nutrition within the past 6 months; Prior history of gastric pancreatic, hepatic, and\u002For splenic surgery\n16. Prior embolization to the stomach, spleen or liver, unless the prior embolization was a transarterial chemoembolization (TACE) to the liver for HCC.\n17. If review of available prior imaging studies (i.e CT, MRI, or US)shows potential anatomical variations, presence of severe atheromatous disease, large arteriovenous shunting of blood.\n18. Abnormal Endoscopy - large sliding hiatal hernia or paraesophageal hernia, active peptic ulcer disease, active H. pylori infection\n19. History of abnormal Nuclear Gastric Motility examination-defined as delayed emptying of gastric contents \\> 90%, 60% and 10% at 1 hour, 2 hours, and 4 hours respectively.\n20. ASA Class 4 or 5\n21. Child Pugh classification C\n22. Known aortic disease, such as dissection or aneurysm; peripheral arterial disease or other cardiovascular disease.\n23. Type 2 diabetes on anti-diabetic medications that are known to cause hypoglycemia. e.g. sulphonylureas, meglitinides\n24. Patients with a known other cause for their increased liver enzyme levels such as viral hepatitis (B or C), autoimmune\u002Fchronic immune hepatitis, primary biliary cholangitis, metabolic and genetic hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency\n25. Patient taking hepatotoxic drugs. List of drugs causing steatohepatitis include but are not limited to: amiodarone, chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase), glucocorticoids, methotrexate, sulfonamides, antithyroid drugs, phenytoin, tetracyclines, isoniazid, salicylates, and valproic acid.\n26. Contraindications to obtaining a liver biopsy (NASH cohort)\n27. Patients taking other trial medications for NASH.",true,"22 Years","65 Years",{"count":140,"type":18},8,[142],"NA","Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant.\n\nRecent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.",[145,146,147,23,22,148],"Obesity","Weight Loss","Body Weight","NAFLD",[150,151,152,153,154,155],"bariatric surgery","minimally invasive","Embolization","NASH","ghrelin","gastric artery embolization","NOT_YET_RECRUITING","2025-07-23",{"date":159,"type":35},"2025-07-28",{"date":161,"type":18},"2025-12",{"date":163,"type":18},"2027-06",{"name":165,"class":42},"Keith Pereira, MD:",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":15,"minAge":173,"maxAge":73,"enrollmentInfo":174,"targetDuration":4,"studyType":76,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":43},"100400989","phase-2-low-dose-pioglitazone-in-patients-with-nash-aim-2-100400989","NCT04501406","Low-Dose Pioglitazone in Patients With NASH (AIM 2)","Effect of Low-Dose Pioglitazone in Patients With Nonalcoholic Steatohepatitis (NASH)","Inclusion criteria:\n\n1. Able to communicate meaningfully with the investigator and legally competent to provide written informed consent.\n2. Aged 21 to 75 years.\n3. Patients with a diagnosis T2DM based on prior medical history, medication use, or results from a fasting plasma glucose or hemoglobin A1c, according to American Diabetes Association guidelines.\n4. Patients will be allowed to participate the glycosylated hemoglobin (HbA1c) is ≤ 9.5% on diet alone or on a stable dose (for at least 2 months) of the following diabetes medications: metformin, sulfonylurea, acarbose, DPP-IV inhibitors, SGLT2 inhibitors or insulin. The insulin total daily dose should be stable (defined as within 20% for the prior 2 months prior to study entry). A GLP-1 receptor agonist will be allowed if on a stable dose for 6 months prior to enrollment and body weight stable (defined as within 3%) in the prior 3 months. Diabetes medications will be continued at stable doses during the entire study (except if glycemic control deteriorates based on HbA1c; addition of metformin, sulfonylurea, acarbose, DPP-IV or insulin will be allowed if needed; pioglitazone, GLP-1RA or SGLT2 inhibitors will not).\n5. Hemoglobin level of at least 11.0 g\u002FL (men) or at least 10.0 g\u002FL (women), leukocyte count of at least 3.0 × 109 cells\u002FL, neutrophil count of at least 1.5 × 109 cells\u002FL, platelet count of at least 100 × 109 cells\u002FL, albumin level of at least 2.5 g\u002FL, serum creatinine level of 2.5 mg\u002FdL or less, INR \\> 1.4, bilirubin \\> 1.3 mg\u002FdL (unless if non-conjugated bilirubin elevated in the setting of Gilbert's syndrome), and AST and ALT levels no more than 8 times the ULN.\n\nExclusion criteria:\n\n1. Past or current history of alcohol use (\\>20 g\u002Fd of ethanol in females or \\>30g\u002Fd in males). Alcohol abuse will be ruled out on the basis of physicians' judgment, self-reported alcohol use, and family members' report of the patient's alcohol use. In addition, the Alcohol Use Disorders Identification Test (AUDIT) score will be used to assess alcohol use.\n2. Receipt of long-term therapy with medications known to have adverse effects on glucose tolerance, unless the patient has been receiving a stable dose of such agents for 4 weeks before study entry.\n3. Use of medications that could induce steatosis, such as estrogen or other hormonal replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, pharmacological doses of oral glucocorticoids (≥10 mg per day of prednisone or equivalent), or chloroquine.\n4. Use of vitamin E (doses ≥800 IU\u002Fdy) or pioglitazone or any FDA-approved drug for NASH to be approved during the study.\n5. Any cause of chronic liver disease other than NASH, including but not restricted to alcohol or drug abuse, medication, chronic hepatitis B or C virus infection, autoimmune liver disease, hemochromatosis, Wilson disease (if younger than age 50), α1-antitrypsin deficiency, history of exposure to hepatotoxic drugs or history of primary or metastatic liver cancer.\n6. Presence of other medical conditions known to cause fatty liver disease.\n7. Any clinical or laboratory evidence of cirrhosis or hepatic decompensation, such as history of ascites, esophageal bleeding varices, or spontaneous encephalopathy.\n8. Prior or scheduled surgical procedures, including gastroplasty or jejunoileal or jejunocolic bypass.\n9. Prior exposure to organic solvents, such as carbon tetrachloride.\n10. Total parenteral nutrition within the past 6 months.\n11. Patients with other forms of diabetes other than T2DM.\n12. History of clinically significant heart disease such as congestive heart failure (New York Heart Association Classification greater than grade II-IV), unstable cardiovascular disease such as unstable angina (i.e., new or worsening symptoms of coronary heart disease within the past 6 months), acute coronary syndrome or coronary artery intervention within the past 6 months, acute myocardial infarction in the past 6 months; history of (within prior 6 months) or current unstable cardiac dysrhythmias.\n13. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg); clinically evident peripheral vascular disease (history of claudication); stroke or transient ischemic attack within the prior 6 months; clinically significant pulmonary disease (dyspnea on exertion of ≤1 flight; abnormal breath sounds on auscultation), or kidney disease as defined above per plasma creatinine elevation or significant proteinuria (macroalbuminuria).\n14. Pregnancy or lactation in women. Must have a negative pregnancy test or at least be two-year post-menopausal. Women with childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) must be using a highly effective method of contraception (i.e. combined (estrogen and progesterone containing) hormonal\u002F progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner). The contraceptive method will have to be followed for at least one menstruation cycle after the end of the study.\n15. History of malignancy in the past 5 years and\u002For active neoplasm with the exception of resolved superficial nonmelanoma skin cancer.\n16. History of bladder disease and\u002For hematuria or has current hematuria unless due to a recent urinary tract infection.\n17. Hemostasis disorders or current treatment with anticoagulants.\n18. Any other criteria that based on the assessment of the research team the patient is deemed to be a poor research candidate.","21 Years",{"count":175,"type":18},166,[78],"To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).",[179,23],"Type 2 Diabetes Mellitus (T2DM)",[181],"Nonalcoholic fatty liver disease; pioglitazone.","2025-04-02",{"date":184,"type":35},"2025-04-04",{"date":186,"type":35},"2020-12-15",{"date":188,"type":18},"2027-08-31",{"name":190,"class":42},"University of Florida",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":136,"sex":15,"minAge":197,"maxAge":138,"enrollmentInfo":198,"targetDuration":4,"studyType":76,"phases":200,"briefSummary":201,"conditions":202,"keywords":208,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":43},"100451992","longitudinal-multi-omic-profiles-to-reveal-mechanisms-of-obesity-mediated-insulin-resistance-100451992","NCT05165706","Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance","Inclusion Criteria:\n\n* Age 35-65\n* BMI 25-35 kg\u002Fm2\n* Stable body weight\n* Nondiabetic\n\nExclusion Criteria:\n\nPatients with;\n\n* diabetes\n* major organ disease\n* history of liposuction or bariatric surgery\n* active eating or psychiatric disorder\n* pregnancy or lactation, heavy alcohol use\n* recent change in weight (over the past 12 weeks)\n* use of weight loss medication, statins, or oral steroids\n\nClinical screening exclusions;\n\n* hematocrit \\\u003C 33%\n* fasting glucose \\>\u002F= 126 mg\u002FdL\n* blood pressure \\>160\u002F100 mmHg","35 Years",{"count":199,"type":18},110,[142],"This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR). Blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. Additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.",[203,204,205,145,23,206,207],"Diabetes Mellitus, Type 2","PreDiabetes","Insulin Resistance","Nonalcoholic Fatty Liver","Diet Modification",[209,210,211,212],"Metabolomics","Low Fat Diet","Low Carbohydrate Diet","Microbiome","2024-12-02",{"date":215,"type":35},"2024-12-04",{"date":217,"type":35},"2019-01-31",{"date":219,"type":18},"2026-12-30",{"name":221,"class":42},"Stanford University",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":136,"sex":15,"minAge":229,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":76,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":43},"100472307","metabolic-pathology-of-pediatric-nafld-100472307","NCT05430178","Metabolic Pathology of Pediatric NAFLD","Understanding the Metabolic Pathology of Pediatric Obesity and NAFLD","Inclusion Criteria:\n\n* Age: All participants must be 10.0 to 20.9 years old at the time of enrollment.\n* Sex: Male and Female participants are eligible.\n* Race\u002FEthnicity: Participants of all racial\u002Fethnic identities will be recruited.\n* Body mass index (BMI): Participants must be either in the normal weight (NW control group) or obese \\[Ob control, nonalcoholic fatty liver disease (NALFD) groups\\] range for BMI percentile. BMI percentile will be calculated from age- and sex-specific growth charts for children.\n* NAFLD status: The NAFLD group participants will be eligible if they are scheduled for liver biopsy for clinical reasons and their histopathology report confirms a diagnosis of NAFLD. NW control, and Ob control, and Liver control participants must not have diagnosed NAFLD.\n\nExclusion Criteria:\n\n* Chronic illness: Participants will not be able to participate if they have conditions that are likely to affect metabolic variables (either directly or due to required medications) or result in them being unable to complete the required tests. Such conditions could include, but are not limited to, untreated hypothyroidism or other endocrine disorders, rheumatoid arthritis requiring steroids or limiting mobility, cardiovascular disease, stroke, or cardiac failure, neurological disorders such as multiple sclerosis, cancer, liver diseases other than NAFLD (e.g., Wilson's disease), other organ disorders, or orthopedic conditions that limit physical activity.\n* Acute illness: Participants will not be able to participate if they develop acute conditions that are likely to affect metabolic outcomes (either directly or due to required medications) or result in them being unable to participate; e.g., respiratory illness, infectious disease, fever, accident resulting in bone fractures, myocardial infarction, major depression. If such conditions resolve and there are no longer risks or likelihood of adverse effect on the study outcomes, participants may be rescheduled for testing.\n* Medications and nutritional supplements: Medications, vitamins, or supplements that have known effects on the primary outcomes will be cause for exclusion. Examples include weight loss medications, glucocorticoids, or experimental medications used to correct a metabolic or hepatic condition. Medications used to control asthma, allergies, anxiety, depression, attention deficit disorder, menstrual cycle, hypothyroidism, gastric reflux, hypertension, and sleep will be allowed. Participants who are taking medications for treatment of acute illness or conditions such as cold, flu, injury, or infection will be rescheduled after they complete their treatment course.\n* Pregnancy: Evidence of pregnancy or intent to become pregnant during the study is cause for exclusion.\n* Smoking, alcohol abuse, or illicit drug abuse: Participants who smoke or have signs or symptoms of alcohol or substance abuse will be excluded.","10 Years","20 Years",{"count":232,"type":18},100,[142],"Nonalcoholic fatty liver disease (NAFLD) is now the most common liver disease worldwide and affects nearly 40% of obese youth and up to 10% of the general pediatric population. Some features of NAFLD are similar in children and adults, yet fibrosis and inflammation are more common in the portal zone and occur earlier in pediatric NAFLD patients than adults. This portends a rapid progression to end-stage liver disease in early adulthood. For the majority of children with NAFLD, mechanisms driving the origin and rapid progression of disease remain unknown. Thus, there is a critical, unmet need to study the specific underlying patterns of metabolic and molecular changes in the liver underlying the development and progression unique to children with NAFLD.\n\nThis proposal will test the hypotheses that children with NAFLD have excess glucose and lipid produced by the liver, that those events are regulated by specific variations in the amount and location of RNAs and proteins in liver, and that the concentration of specific micro-RNAs in the blood can be used as a biomarker for NAFLD in pediatric patients.",[206,23,145],"2024-03-04",{"date":238,"type":35},"2024-03-06",{"date":240,"type":35},"2022-05-25",{"date":242,"type":18},"2026-06",{"name":244,"class":42},"University of Oklahoma",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":15,"minAge":252,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100307440","great-china-fatter-liver-consortium-gcflc-study-to-assess-the-progress-of-nafldnash-in-chinese-100307440","NCT03282305","Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD\u002FNASH in Chinese","Prospective Cohort Assessing the Prevalence and Progress of Non-alcoholic Fatty Liver Disease (NAFLD)\u002FNon-alcoholic Steatohepatitis (NASH) in Chinese","Inclusion Criteria:\n\n* Adults and children subjects aged \\>= 6 years old\n* Ability to understand and sign a written informed consent form (ICF) or provide assent in pediatric subjects\n* Diagnosis of NAFLD; or a definite or probable diagnosis of NASH:\n\n  1. A diagnosis of NAFLD will be defined by evidence of hepatic steatosis, either by imaging or by histology, with no causes for secondary hepatic fat accumulation such as significant alcohol consumption, use of steato-genic medication (e.g. valproate, amiodarone, anti-retroviral medications, tetracycline, chronic high-dose corticosteroids), or hereditary disorders (e.g. Wilson's disease, Wolman disease, cholesteryl-ester storage disease);\n  2. A definite diagnosis of NASH will be defined by steatohepatitis confirmed by biopsy with correlating clinical evidence of non-alcoholic liver disease;\n  3. A probable diagnosis of NASH will be defined by:\n\n     a.Elevated alanine amino transferase levels (ALT) of \\>40 U\u002FL; and b.Evidence of hepatic steatosis on imaging; or c.Obesity, type 2 diabetes, or pre-diabetes. Pre-diabetes is defined by: i.Impaired fasting glucose: 100 mg\u002FdL-125 mg\u002FdL (5.6 mmol\u002FL-6.9 mmol\u002FL) or; ii.Impaired glucose tolerance: 2-hr plasma glucose (PG) in 75-g Oral Glucose Tolerance Test (OGTT) 140 mg\u002FdL-199 mg\u002FdL (7.8 mmol\u002FL-11.0 mmol\u002FL) or; iii.HbA1C: 5.7%-6.4%.\n\n     Exclusion Criteria:\n* Unable to provide written informed consent (or assent in pediatric subjects)\n* Alcohol consumption greater than 21 units\u002Fweek for males or 14 units\u002Fweek for females (one unit of alcohol is half pint of beer \\[285 mL; 9.64 oz\\], 1 glass of spirits \\[25 mL; 0.85 oz\\] or 1 glass of wine \\[125 mL; 4.23 oz\\]\n* Enrolled in NASH-related clinical trials\n* Presence of other forms of chronic liver disease:\n\n  1. Chronic hepatitis B (HBsAg positive)\n  2. Chronic hepatitis C (HCV RNA positive)\n  3. Iron overload disorders (3-4+ iron on liver biopsy or known hemochromatosis gene (HFE) C282Y homozygous with ferritin \\> 200 ng\u002Fml; note: an elevated ferritin alone is common in NASH and is not exclusionary)\n  4. Autoimmune liver disease (biopsy evidence or clinical diagnosis of autoimmune hepatitis or Primary biliary cholangitis (PBC) requiring ongoing treatment, imaging evidence of Primary sclerosing cholangitis (PSC))\n  5. Wilson's disease\n  6. Alpha-1 antitrypsin mutations that in the opinion of the principal investigator is contributing to the patient's liver disease;\n* Prior bariatric surgery unless the surgery was performed more than one year before the biopsy diagnosis of NASH (i.e., NASH is present despite prior bariatric surgery);\n* Planned bariatric surgery (e.g. gastroplasty, roux-en-Y gastric bypass).","6 Years",{"count":254,"type":18},5000,"Nonalcoholic fatty liver disease (NAFLD) is a progressive liver disease ranging from simple steatosis to cirrhosis of the liver. Nonalcoholic fatty liver (NAFL) without substantial hepatocellular injury is thought to be relatively benign whereas nonalcoholic steatohepatitis (NASH) is characterized by hepatocyte steatosis, ballooning, inflammation and varying degrees of fibrosis from none to cirrhosis. NASH is strongly associated with insulin resistance and metabolic syndrome and thus is recognized as a major public health concern as the most prevalent liver disease.\n\nLiver biopsy is the gold standard for a diagnosis of NASH. However, given the large population of patients at risk for NASH, liver biopsy is not a practical method for determining which patients may benefit from NASH therapy. Non-invasive methods to estimate inflammation and fibrosis are in clinical use, but there remains a dichotomy between gold standard inclusion criteria and end points that are utilized in clinical trials and real world diagnostic methods that are more common in clinical practice.\n\nThus, the investigators would like to conduct an observational study to head-to-head compare the non-invasive methods and liver biopsy in differential liver steatosis and liver biopsy in a real-world setting. Also, by following up patients for a relatively long time (proposed 10 years), the investigators can present the natural history of disease progression.",[206,23],"2018-02-04",{"date":259,"type":35},"2018-02-06",{"date":261,"type":18},"2018-04",{"date":263,"type":18},"2029-12",{"name":265,"class":100},"Great China Fatty Liver Consortium Limited"]