[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nonalcoholic-fatty-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nonalcoholic-fatty-liver-disease":22},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,44,81,116,139,172,211,237,258,279,310,335,359,379],{"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":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100611220","iwaist-trial-ercg-endoscopic-radial-compression-gastroplasty-vs-optimized-lifestyle-intervention-for-weight-loss-100611220","NCT07237750","iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss","iWAIST Trial: A Multicenter, Single-Blind, Randomized, Sham-Controlled Trial of Endoscopic Radial Compression Gastroplasty (ERCG) Plus Optimized Lifestyle Intervention for Weight Management in Chinese Adults With Overweight or Mild-to-Moderate Obesity","iWAIST-RCT","Inclusion Criteria:\n\n* Asian adults aged 18-65 years.\n* BMI 24.0-37.4kg\u002Fm²(Chinese standard)。\n* Failed prior conservative weight loss attempts ≥2 months。\n* Willingness to comply with follow-up.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Prior gastrointestinal surgery with clinically relevant sequelae.\n* Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric\u002Fduodenal ulcer), or neoplastic lesions.\n* Any condition associated with an increased risk of upper gastrointestinal bleeding.\n* Hiatal hernia \\>2 cm or severe\u002Frefractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.\n* Esophageal\u002Fpharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum).\n* Achalasia or other severe esophageal motility disorder.\n* Severe coagulopathy.\n* Insulin-dependent diabetes mellitus.\n* Chronic abdominal pain.\n* Gastrointestinal motility disorder (e.g., gastroparesis).\n* Hepatic impairment or cirrhosis.\n* Severe or uncontrolled psychiatric illness.\n* Alcohol abuse or substance dependence.\n* Unwilling to participate in a physician-supervised diet\u002Fbehavior modification program and\u002For unwilling to comply with routine follow-up.\n* Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating medications.\n* Unable or unwilling to take proton pump inhibitor (PPI) therapy as prescribed during the treatment period.\n* Known or suspected hypersensitivity to any material\u002Fcomponent of the study system.\n* Pregnant or breastfeeding.\n* Severe cardiopulmonary disease or other serious systemic\u002Forganic disease.\n* Positive Helicobacter pylori (H. pylori) test.\n* Use of time-critical medications potentially affected by altered gastric emptying (e.g., antiepileptics, antiarrhythmics).\n* Current systemic corticosteroids, immunosuppressants, or opioid analgesics.\n* Use of any weight-loss medication within the past 3 months or current use.\n* Prior use of any intragastric device.\n* Participation in a weight-affecting clinical trial within the past 6 months.\n* Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable coronary artery disease.\n* Clinically significant respiratory disease.\n* Autoimmune connective tissue disease.\n* Life expectancy \\\u003C1 year or severe renal\u002Fhepatic\u002Fpulmonary or other serious medical illness.\n* Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi syndrome) or other endocrine disease known to affect body weight.\n* Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating disorder, compulsive eating).","18 Years","65 Years",{"count":55,"type":18},216,"INTERVENTIONAL",[58],"NA","Obesity and overweight are rising in Chinese populations, where metabolic risks begin at lower BMI thresholds than in Western cohorts. Many individuals with overweight or mild-to-moderate obesity are ineligible or unwilling to undergo bariatric surgery due to invasiveness and risk. Endoscopic bariatric and metabolic therapies offer minimally invasive alternatives but vary in complexity, cost, and safety profiles. Investigators developed a sutureless endoscopic procedure, Endoscopic Radial Compression Gastroplasty (ERCG), which reduces gastric volume by apposing gastric walls using a clip-and-loop system. This randomized controlled trial evaluates the efficacy and safety of ERCG versus an optimized lifestyle intervention in Asian adults with BMI 24.0-37.4 kg\u002Fm² who have not succeeded with conservative measures. Preliminary studies suggest ERCG can achieve approximately 12% total body weight loss (TBWL) at 3 months. The primary endpoint is percent TBWL at 3 months; secondary outcomes include changes in BMI, metabolic parameters, quality of life, and adverse events. Results are expected to inform the role of ERCG as a safe, effective, and scalable option between conservative care and bariatric surgery.",[61,62,22,63],"Overweight and\u002For Obesity","Metabolic Syndrome","Chinese",[65,66,67,68,69,63,70],"Endoscopic gastroplasty","Endoscopic bariatric therapy","Weight loss","Overweight","Gastric volume reduction","Obesity","2026-03-11",{"date":73,"type":35},"2026-03-13",{"date":75,"type":35},"2026-03-01",{"date":77,"type":18},"2027-05-31",{"name":79,"class":42},"Liu Yan",2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":15,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":91,"studyType":19,"phases":4,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":43},"100612037","validating-integrative-multi-omics-approaches-in-metabolic-syndrome-related-diseases-100612037","NCT07248371","Validating Integrative Multi-omics Approaches in Metabolic Syndrome-related Diseases","Validating Integrative Multi-omics Approaches in Metabolic Syndrome-related Diseases: A Step Towards Precision Medicine","Inclusion Criteria:\n\n* Individuals (male or female) aged 20 years or older\n* Willing and able to provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with end-stage renal disease receiving hemodialysis or peritoneal dialysis\n* Individuals currently undergoing active cancer treatment\n* Recipients of any organ transplantation\n* Patients diagnosed with dementia","20 Years",{"count":90,"type":18},6266,"5 Years","This study aims to validate integrative multi-omics approaches for understanding complications related to metabolic syndrome. By combining genetic, transcriptomic, metabolomic, and microbiome data from participants with and without metabolic syndrome, the research seeks to determine which biological factors predict disease progression and how these insights can inform precision prevention and treatment strategies for metabolic disorders.",[94,95,96,97,22,98],"Metabolic Syndrome (MetS)","Obesity & Overweight","Cardiovascular Diseases (CVD)","Chronic Kidney Disease","Healthy",[62,100,101,102,103,104,105,106],"Multi-Omics","Precision Medicine","Metabolomics","Genomics","Transcriptomics","Microbiome","Machine Learning","2025-11-18",{"date":109,"type":35},"2025-11-25",{"date":111,"type":35},"2025-06-09",{"date":113,"type":18},"2035-09-30",{"name":115,"class":42},"Chang Gung Memorial Hospital",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":43},"100604442","to-explore-the-value-of-new-mr-technology-in-non-invasive-quantitative-assessment-of-systemic-metabolism-disease-status-and-prognosis-in-patients-with-metabolic-associated-fatty-liver-disease-100604442","NCT07149571","To Explore the Value of New MR Technology in Non-invasive Quantitative Assessment of Systemic Metabolism, Disease Status and Prognosis in Patients With Metabolic-Associated Fatty Liver Disease","Inclusion Criteria:\n\n1. Patients with MR examination are clinically suspected or diagnosed with metabolism-related fatty liver disease;\n2. Age\u002Fgender: unlimited;\n3. Patients who voluntarily participate in clinical trials and sign written subject informed consent\n\nExclusion Criteria:\n\n1. Clinical suspicion or diagnosis of metabolism-related fatty liver disease and having been prescribed an MR examination;\n2. Voluntarily participation in the study and provision of written informed consent.",true,{"count":124,"type":18},500,"The purpose of this study is to explore the value of new MR technology in assessing the systemic metabolism, disease status, and prognostic risk of metabolism-related fatty liver disease. By obtaining clinical, imaging, laboratory examination and pathological data of metabolism-related fatty liver disease, image processing software is used to analyze the images, explore the relationship between imaging parameters, body composition and metabolic diseases and metabolism-related fatty liver disease, and achieve non-invasive diagnosis, efficacy evaluation, and prognosis prediction of metabolism-related fatty liver disease. Thereby guiding clinical treatment and improving the prognosis and quality of life of patients with metabolism-related fatty liver disease",[22,127],"Metabolic-associated Fatty Liver Disease",[129],"MRI, metabolism-related fatty liver disease","2025-08-29",{"date":132,"type":35},"2025-09-02",{"date":134,"type":35},"2025-04-01",{"date":136,"type":18},"2032-12-31",{"name":138,"class":42},"Tongji Hospital",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":122,"sex":15,"minAge":146,"maxAge":53,"enrollmentInfo":147,"targetDuration":4,"studyType":56,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"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.","22 Years",{"count":148,"type":18},8,[58],"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.",[70,152,153,23,22,154],"Weight Loss","Body Weight","NAFLD",[156,157,158,159,160,161],"bariatric surgery","minimally invasive","Embolization","NASH","ghrelin","gastric artery embolization","NOT_YET_RECRUITING","2025-07-23",{"date":165,"type":35},"2025-07-28",{"date":167,"type":18},"2025-12",{"date":169,"type":18},"2027-06",{"name":171,"class":42},"Keith Pereira, MD:",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":122,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":56,"phases":182,"briefSummary":183,"conditions":184,"keywords":193,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"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":181,"type":18},45,[58],"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",[22,185,186,187,154,188,189,190,191,192],"Nonalcoholic Fatty Liver Disease (NAFLD)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","MASLD","Metabolic Dysfunction-Associated Steatotic Liver Disease","NAFLD (Nonalcoholic Fatty Liver Disease)","NAFLD (Non-alcoholic Fatty Liver Disease)","NAFLD - Non-Alcoholic Fatty Liver Disease","NAFLD - Nonalcoholic Fatty Liver Disease",[194,195,187,154,22,196,197,198,199,200,188],"LM pectin","pectin","Systemic Inflammatory Response","Dietary Fiber","Dietary Fibre","Diet","gut microbiota","2025-07-22",{"date":203,"type":35},"2025-07-30",{"date":205,"type":35},"2025-06-10",{"date":207,"type":18},"2027-03-31",{"name":209,"class":42},"University of Nottingham",3,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":56,"phases":221,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":236},"100559473","phase-2-phase-2a-study-of-safety-tolerability-and-efficacy-of-tlc-2716-in-subjects-with-hypertriglyceridemia-and-nafld-100559473","NCT06564584","Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD","A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease","Inclusion Criteria:\n\n* BMI ≥ 28 kg\u002Fm2 at Screening\n* Fasting TG ≥ 350 mg\u002FdL\n* Subjects without diabetes or subjects with diabetes and HbA1c \\\u003C 9.5% at Screening\n* Screening laboratory evaluations (eGFR, ALT, AST, INR, total bilirubin, platelet count) must fall within the protocol-defined ranges\n* A clinical diagnosis of NAFLD\u002FNASH within 5 years of Screening based on historical hepatic imaging (e.g., ultrasound, MRI, computed tomography \\[CT\\], or Controlled Attenuation Parameter \\[CAP\\] by vibration-controlled transient elastography ≥ 250 dB\u002Fm), and no documented weight loss \\> 5% between the date of the historical hepatic imaging and Screening OR a historical liver biopsy within 5 years of Screening consistent with NAFLD\u002FNASH without cirrhosis and no documented weight loss \\> 5% between the date of the historical liver biopsy and Screening\n* Normotensive subjects or subjects without uncontrolled hypertension, defined as systolic blood pressure \\> 155 mmHg and\u002For diastolic blood pressure \\> 90 mmHg at Screening\n* A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigator\n* Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to first dose of study drug\n* Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n\nExclusion Criteria:\n\n* HbA1c ≥ 9.5% at Screening\n* Weight loss \\> 5% during the 90 days prior to Screening\n* Pregnant or lactating subjects.\n* Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody\n* Medical history of liver disease other than NAFLD\u002FNASH, including but not limited to, alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency.\n* Any history of cirrhosis or decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding, or Child-Pugh-Turcotte score \\> 6 at Screening\n* Unstable cardiovascular disease\n* History of intestinal resection or malabsorptive condition that may limit the absorption of study drug. Appendectomy and cholecystectomy are not exclusionary.\n* Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at Screening, in the opinion of the investigator\n* Any scheduled surgery during the trial period, excluding minor surgical procedures performed under local anesthesia, in the opinion of the investigator\n* History of malignancy within 5 years prior to Screening except adequately treated carcinoma in situ of the cervix, and\u002For squamous cell cancer, or other localized non-melanoma skin cancer\n* History of significant drug allergy, such as anaphylaxis or significant drug sensitivity, in the opinion of the investigator\n* Known hypersensitivity to study drug, its metabolites, or formulation excipients\n* Presence of any medical condition that could, in the opinion of the investigator, compromise the subject's ability to participate in the study, including a history of substance abuse or a psychiatric disorder, including any subject with a psychiatric hospital admission or emergency room visit in the 2 years prior to Screening\n* Any laboratory abnormality that in the opinion of the investigator could adversely affect the safety of the subject or impair assessment of study results\n* Medications or therapies prescribed or taken over-the-counter for weight loss, in the 90 days prior to Screening\n* Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply","70 Years",{"count":220,"type":18},30,[222],"PHASE2","This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.",[225,22],"Hypertriglyceridemia","2025-03-31",{"date":228,"type":35},"2025-04-03",{"date":230,"type":35},"2024-08-12",{"date":232,"type":18},"2025-09",{"name":234,"class":235},"OrsoBio, Inc","INDUSTRY",4,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":43},"100275322","follow-up-of-chronic-hepatitis-b-patients-with-comorbid-nonalcoholic-fatty-liver-disease-100275322","NCT02863757","Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease","Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)","Inclusion Criteria:\n\n* Liver biopsy proved CHB and\u002For NAFLD at baseline;\n* Chinese\n* Follow-up duration\\>12 months\n\nExclusion Criteria:\n\n* Other liver diseases;\n* Secondary causes of hepatic steatosis;\n* Alcohol abuse;\n* Liver cirrhosis, cirrhosis related complications or HCC at baseline;\n* Malignancy;\n* History of liver transplantation",{"count":245,"type":18},1500,"The purpose of this study is to determine the disease progression in CHB\u002FNAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).",[248,22],"Chronic Hepatitis B","2025-03-20",{"date":251,"type":35},"2025-03-24",{"date":253,"type":35},"2016-08-01",{"date":255,"type":18},"2026-12",{"name":257,"class":42},"Humanity and Health Research Centre",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":265,"targetDuration":4,"studyType":56,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":43},"100477297","gastric-bypass-stent-small-sample-size-study-for-nonalcoholic-fatty-liver-disease-100477297","NCT05495139","Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease","A Small-Sample-Size Clinical Study to Evaluate the Effectiveness and Safety of the Gastric Bypass Stent System in Treatment of Patients With Nonalcoholic Fatty Liver Disease.","Inclusion Criteria:\n\n（ - ） Males or females with age between 18 and 65 years old;\n\n（ - ） Diagnosis of nonalcoholic fatty liver disease;\n\n（ - ） Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%;\n\n（ - ） BMI≥24;\n\nPatients who understand the objective of the study; voluntarily participate in the study and have signed the informed consent form; and are able and willing to comply with all requirements, including follow up and evaluations.\n\nExclusion Criteria:\n\n（ - ） History of excessive alcohol consumption (alcohol consumption equivalent to ethanol \\> 30 g\u002Fd for males and \\> 20 g\u002Fd for females);\n\n（ - ） End-stage liver disease (e.g. hepatic cirrhosis or hepatic cancer) or other conditions which may lead to fatty liver;\n\n（ - ） Unable to cooperate to complete MR examination;\n\n（ - ） Subjects who have used any nonsteroidal anti-inflammatory drug or corticosteroid in the past month;\n\n（ - ） Patients with iron deficiency or iron deficiency anemia;\n\n（ - ） ALT or AST increased to 8 × upper limit of normal (ULN), and bilirubin increased to 2×ULN;\n\n（ - ） Patients with coagulation disorder or haemorrhagic diathesis (platelets \\\u003C100×109\u002FL);\n\n（ - ） Patients with duodenal ulcer, or previous or existing pancreatitis;\n\n（ - ） History of liver abscess;\n\n（ - ） History of gallstones (symptomatic or presenting of any stone with a diameter greater than 20mm);\n\n（ - ） Patients with gastrointestinal hemorrhage or potential hemorrhage;\n\n（ - ） Gastrointestinal tract anomalies, such as gastrointestinal tract atresia or any or other conditions that would result in failed placement in the gastrointestinal tract;\n\n（ - ） Patients with history of intestinal obstruction or related disease in the past year;\n\n（ - ） Drug abusers or patients with uncontrollable psychiatric disorders;\n\n（ - ） Patients with any contraindication to endoscopy based on the investigator's judgment;\n\n（ - ） Pregnancy or lactating women;\n\n（ - ） Patients who are participating in any other drug or medical device clinical study;\n\n（ - ） Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial;",{"count":266,"type":18},10,[58],"Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.",[22],"2024-06-25",{"date":272,"type":35},"2024-06-26",{"date":274,"type":35},"2022-12-15",{"date":276,"type":18},"2026-06-30",{"name":278,"class":42},"Hangzhou Tangji Medical Technology Co., Ltd.",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":56,"phases":290,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":43},"100550650","phase-4-effect-of-henagliflozein-on-hepatic-fat-content-in-patients-with-t2dm-and-nafld-100550650","NCT06449833","Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD","Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Multicenter, Randomized, Controlled Clinical Trial","HHTN","Inclusion Criteria:\n\n1. Patients diagnosed with type 2 diabetes within 5 years (According to the diagnostic criteria of WHO Diabetes Classification 2019)\n2. Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)\n3. Well-controlled blood glucose through diet and exercise intervention, or stable treatment with 1 or 2 types of hypoglycemic drugs (metformin, sulfonylurea, glinide, α-glycosidase inhibitor ) for at least 8 weeks with a half or full recommended maximum tolerated dose in instructions.\n4. HbA1c: 7.0%-8.5%\n5. Patients diagnosed with non-alcoholic fatty liver disease (According to the diagnostic criteria of Guidelines for Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease 2010)\n\nExclusion Criteria:\n\n1. Patients with type 1 diabetes, gestational diabetes or other special types of diabetes;\n2. Patients with any acute, chronic complication or risk that may cause greater adverse effects than benefits through the trial; or receiving other treatment currently that may affect subjects' compliance or the objectivity of the end point of this trial; (1)Patients with serious acute complications of diabetes in the past 6 months (Eg. diabetic ketoacidosis, hyperosmotic hyperglycemia coma); (2)Patients with unstable proliferative retinopathy or maculopathy,severe diabetic neuropathy, intermittent claudication or diabetic foot in the past 6 months; (3)Patients with serious liver dysfunction and chronic kidney disease or disease of other systems (Eg. Acute and chronic pancreatitis, liver cirrhosis, nephrotic syndrome ect. ); and those who do not meet the requirements after being evaluated by professionals; (4)Have a history of myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, or underwent coronary angioplasty, percutaneous coronary stenting or coronary artery bypass grafting 6 months before the screening; or screening for congestive heart failure (New York Heart Association NYHA grade III and IV), unstable or acute congestive heart failure, or persistent arrhythmias believed to be life-threatening within the first 6 months of the trail; (5)Have a history of hemorrhagic stroke or ischemic stroke in the past 6 months, and was evaluated by the researchers as not suitable to participate in this clinical trial; (6)Have a history of hypertension and was not effectively controlled before screening: systolic blood pressure (SBP) ≥ 160mmHg and \u002F or diastolic blood pressure (DBP) ≥ 100mmHg;\n3. Have a history of other endocrine system diseases which affect glucose and lipid metabolism or have an effect on the body weight, such as: multiple endocrine adenomatosis, acromegaly, Cushing syndrome, hyperthyroidism;\n4. Have a history of malignant tumour within 5 years before screening, except for local basal cell carcinoma of the skin after treatment；\n5. Have a history of severe infection, trauma or major surgery within 3 months;\n6. Have a history of drug abuse with 5 years, including repeated use of dependence-producing drug unrelated to medical purposes, including addictive and habitual drugs leading to physical and psychic dependence;\n7. Have a history of participating any intervention drug or instrumental clinical trial 3 months before screening;\n8. Have a history of severe anemia or need regular blood transfusion treatment;\n9. Have a history of any medication or treatment below:\n\n(1)Using drugs that may cause weight change 90 days before screening, including diuretics, weight-loss drug etc.; (2)Using drugs that may affect blood glucose for \\>1 week within 12 weeks, such as oral\u002Fintravenous glucocorticoid, growth hormone, estrogen\u002Fprogesterone, high-dose diuretics, antipsychotic drugs, etc., but low-dose diuretics for antihypertensive purposes (hydrochlorothiazide \\\u003C 25mg\u002Fd, indapamide \\\u003C 1.5 mg\u002Fd) are not included in this restriction; (3)Had bariatric sugery or planning to have bariatric surgery; 10.The laboratory results of patients meet the following standards:\n\n1. AlanineAminotransferase(ALT)and\u002Foraspartateaminotransferase(AST) higher than 5 times of the upper limit of the normal value.\n2. Glomerular Filtration Rate (eGFR) estimated by CKD-EPI formula \\\u003C 40mL\u002F (min·1.73m2); 11.Patients are currently pregnant, breastfeeding or planning a pregnancy; 12.Have a history of infectious diseases such as hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), pulmonary tuberculosis or sexually transmitted active diseases such as HIV and syphilis; 13.Have a history of using anti-NASH drugs (vitamin E, ursodeoxycholic acid, s-Adenosylmethionine, betaine, silymarin, gemdibrozil, anti-TNF therapy, probiotics, ect.) within 3 months before random grouping; 14.Having structural and functional genitourinary abnormalities prone to cause genitourinary infection; 15.Patients with abnormal hematologic system or any diseases that may cause hemolysis or unstable erythrocyte; 16.Have a history of using immunomodulators, such as biological agents, cyclophosphamide, cyclosporine, etc.; 17.Patients with MRI incompatible metal or magnetic implant, device or materials.","75 Years",{"count":289,"type":18},100,[291],"PHASE4","This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.",[294,22],"Type2 Diabetes Mellitus",[296,297,298,299,300],"Type 2 Diabetes Mellitus","Nonalcoholic fatty liver disease","Hepatic Fat Content","Henagliflozein","liver function","2024-06-03",{"date":303,"type":35},"2024-06-10",{"date":305,"type":18},"2024-06",{"date":307,"type":18},"2026-11",{"name":309,"class":42},"Zhujiang Hospital",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":56,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":334},"100544438","phase-4-efficacy-and-safety-of-antiviral-therapy-with-peg-interferon-for-chronic-hepatitis-b-complicated-with-nonalcoholic-fatty-liver-diseaseocean-project-100544438","NCT06368882","Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）","Inclusion Criteria:\n\n1. Age of 18-60 years old, male or female (including 18 and 60 years old);\n2. meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition), and meet the imaging diagnostic criteria for fatty liver in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 Update edition).\n3. serum HBsAg positive \\>6 months;\n4. NAs treatment: baseline HBsAg≤1500 IU\u002Fml, HBeAg negative, HBV DNA negative (not detected);\n5. IHC initial treatment: baseline HBsAg\\\u003C1000 IU\u002Fml, HBeAg negative, HBV DNA negative (undetectable), ALT and AST persistently normal (ULN: \\\u003C50 IU\u002FL in men, \\\u003C40 IU\u002FL in women);\n6. a negative serum pregnancy test within 24 hours before the first dose (for women of reproductive age);\n7. willing to receive treatment and signed informed consent.\n\nExclusion Criteria:\n\n1. co-infection with active hepatitis A, C, D, E and\u002For HIV; Or combined with drug-induced liver injury, inherited metabolic liver disease, autoimmune hepatitis, alcoholic liver disease;\n2. Liver tumor was detected by liver imaging at the time of screening;\n3. patients diagnosed with hepatitis B cirrhosis, that is, those with liver biopsy pathology consistent with liver cirrhosis, or with two or more of the following five criteria, excluding non-cirrhotic portal hypertension: ① imaging examination showed signs of liver cirrhosis and\u002For portal hypertension; ② Esophagogastric varices were found by endoscopy; ③ Liver stiffness was consistent with cirrhosis; ④ Blood biochemical examination showed decreased albumin level (\\\u003C 35 g\u002FL) and\u002For prolonged prothrombin time (prolonged \\> 3 seconds compared with the control); ⑤ Blood routine examination showed platelet count \\\u003C 100×109\u002FL;\n4. pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period;\n5. neutrophil count \\\u003C1.5×109\u002FL or platelet count \\\u003C90×109\u002FL. Patients with creatinine higher than 1.5 times the upper limit of normal;\n6. The patients and their close relatives (parents, siblings, etc.) had a history of severe mental illness, especially depression. Severe psychosis is defined as severe depression or psychosis, suicide attempt, hospitalization due to psychosis, or a period of incapacitation due to psychosis;\n7. patients with a history of immune-mediated diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies;\n8. patients with serious diseases of heart, lung, kidney, brain, blood and other important organs, and patients with other malignant tumors;\n9. history of severe epilepsy or current use of antiepileptic drugs. Control of unstable diabetes, hypertension, thyroid disease, etc. A history of severe retinopathy or other evidence of retinopathy;\n10. any history of organ transplantation and existing functional graft (except corneal or hair transplantation);\n11. patients who are allergic to interferon and its drug components, and who are not suitable for interferon according to the investigator's judgment;\n12. Patients deemed by the investigator to be ineligible for the study.","60 Years",{"count":245,"type":18},[291],"This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.\n\nA total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.\n\nThe primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.\n\nThe security assessment includes adverse events, vital signs, and imaging.",[22,321],"Chronic Hepatitis b",[22,248,323,324],"Peg-Interferon α","nucleo(s)tide analogues","2024-04-11",{"date":327,"type":35},"2024-04-16",{"date":329,"type":35},"2024-01-01",{"date":331,"type":18},"2028-12-31",{"name":333,"class":42},"First Affiliated Hospital of Wenzhou Medical University",5,{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":316,"enrollmentInfo":342,"targetDuration":344,"studyType":19,"phases":4,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":43},"100492887","non-alcoholic-fatty-liver-disease-in-a-saudi-cohort-with-type-2-diabetes-mellitus-100492887","NCT05697991","Non-Alcoholic Fatty Liver Disease in a Saudi Cohort With Type 2 Diabetes Mellitus","CORDIAL","Inclusion Criteria:\n\n* Subject has provided informed consent prior to screening\n* Men and women aged 18 to 60 years\n* T2DM\n\nExclusion Criteria:\n\n* Evidence of hepatic decompensation (ascites, clinical jaundice-bilirubin ≥ 40 µmol\u002FL, encephalopathy)\n* Preexisting hepatocellular carcinoma\n* Other preexisting hepatic or extrahepatic malignancy\n* Previous overt ischemic heart disease (myocardial infarction or acute coronary syndrome) or cerebrovascular disease (stroke or transient ischemic attack)\n* Previous coronary artery bypass grafting, angioplasty, or stenting\n* Any other issues that, in the opinion of the investigators, may preclude satisfactory completion of the study protocol",{"count":343,"type":18},1000,"15 Years","The global rise in the prevalence of obesity paved the way for the increased prevalence of yet another obesity-related complication significant enough to be considered within the roster of major public health threats: non-alcoholic fatty liver disease (NAFLD). In this follow-up study, the investigators will attempt to decipher the natural history of hepatic steatosis among patients with type 2 diabetes mellitus (T2DM) using state-of-the-art methods in a well-characterized Saudi cohort. The investigators aim also to validate existing biomarkers of disease severity and explore the pathogenesis of progressive disease using metabolic profiling technologies. A total of 1000 adult Saudi patients (males and females) with T2DM will be recruited. Those with co-morbidities, including hepatic decompensation, will be excluded. Participants will be followed three times for a total of 10 years\u002Fpatient (Year 2, Year 5, and Year 10), and measures such as dietary evaluations, anthropometrics, and urine, stool, and blood examinations will be performed. Patients who develop NAFLD will be noted, and patterns\u002Fchanges in the metabolic profile will be examined. For this specific grant (the first 2 years of the whole project), the investigators will be able to recruit the study cohort, do the baseline anthropometric, imaging, and biochemical measurements, and report the prevalence of NAFLD among patients with T2DM. This information will be the basis of subsequent follow-up and allow for validating potential diagnostic and prognostic biomarkers. This project will be of high importance at the national level since it will create awareness in the local medical community of the current severity status of NAFLD in the kingdom and will be used as a tool to promote public health awareness in the community.",[22,296],[348,349,154],"T2DM","Fatty Liver Disease","2023-10-03",{"date":352,"type":35},"2023-10-05",{"date":354,"type":35},"2015-03-23",{"date":356,"type":18},"2030-12-31",{"name":358,"class":42},"King Saud University",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":122,"sex":15,"minAge":52,"maxAge":287,"enrollmentInfo":366,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":43},"100487335","observational-study-about-patients-diagnosed-with-nafld-100487335","NCT05625750","Observational Study About Patients Diagnosed With NAFLD","Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease","Inclusion Criteria:\n\n1\\. patients diagnosed with nonalcoholic fatty liver disease\n\nExclusion Criteria:\n\n1. patients suspected of excessive alcohol consumption\n2. malignant tumors, dementia, active tuberculosis, AIDS, organ failure, pregnancy or breastfeeding, etc cannot cooperate with the investigation\n3. incomplete data such as HBV serological results and abdominal ultrasound results\n4. patients who refuse to sign informed consent",{"count":124,"type":18},"Nonalcoholic fatty liver disease (NAFLD) is the most common condition affecting the liver, owing to its association with obesity and the metabolic syndrome. The largest study to date using magnetic resonance spectroscopy to quantify liver triglyceride (TG) content showed that approximately 33% of individuals have hepatic steatosis. NAFLD encompasses a continuum of histological findings that starts with steatosis that can progress to nonalcoholic steatohepatitis (NASH), which is characterized by inflammation and cell death, and eventually cirrhosis. Given the large number of individuals afflicted with this condition, there is a clear need to develop effective and safe therapies to treat NAFLD.",[22],[22],"2022-11-25",{"date":372,"type":35},"2022-11-30",{"date":374,"type":35},"2022-04-27",{"date":376,"type":18},"2027-04-27",{"name":378,"class":42},"Xiangya Hospital of Central South University",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":387,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":43},"100241515","prospective-cohort-with-biobanking-of-patients-with-nonalcoholic-fatty-liver-disease-100241515","NCT02422238","Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease","Disease Mechanisms and Markers for Non-alcoholic Steatohepatitis in a Population With Non-alcoholic Fatty Liver Disease: a Prospective Cohort Study With Biobank","NAFLD-cohort","Inclusion Criteria:\n\n* NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (using MRI) or by histology.\n* BMI ≥ 30 kg\u002Fm2\n* Between 18 - 65 years of age\n\nExclusion Criteria:\n\n* Incompetent to understand and\u002For sign the informed consent.\n* Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis\n* Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female.\n* Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker).\n* Not willing to be informed about unexpected findings by MRI\n* Unwilling to collect bio samples.\n* Pregnancy and breastfeeding.\n* Indication or planned for bariatric surgery within one year after inclusion or a history of bariatric surgery.\n* Diagnosis of liver cirrhosis and\u002For hepatocellular carcinoma.\n* Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.\n* Individuals about to undergo or recovering from a surgical or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time",{"count":124,"type":18},"The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with proven NAFLD based on liver biopsy and\u002For MRI, is to study factors contributing to the development of NASH in patients with simple steatosis and to identify and validate non-invasive markers for the diagnosis of NASH.",[22],"2016-09-12",{"date":392,"type":18},"2016-09-13",{"date":394,"type":4},"2015-06",{"date":396,"type":18},"2027-12",{"name":398,"class":42},"Maastricht University Medical Center"]