[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-dysfunction-associated-fatty-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-dysfunction-associated-fatty-liver-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,45,67,97,128,154,175,204,227,252,270,295],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100643538","diagnostic-value-of-the-liver-inflammation-index-for-mash-in-patients-with-t2dm-and-mafld-100643538",false,"NCT07632677","Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD","A Multicenter Cross-Sectional Study Evaluating the Diagnostic Accuracy of the Liver Inflammation Index for Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Patients With Concurrent Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease","Inclusion Criteria:\n\n1. Adults aged ≥18 years, with no restrictions on sex;\n2. Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Nonalcoholic) Fatty Liver Disease (2024 Edition), and additionally diagnosed with type 2 diabetes mellitus (T2DM) based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition).\n\nExclusion Criteria:\n\n1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;\n2. Development of other liver diseases during follow-up, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, or other chronic liver diseases;\n3. History of hepatic decompensation;\n4. History of hepatectomy or liver transplantation;\n5. History of other malignancies;\n6. Presence of vascular liver disease, cystic fibrosis-associated liver disease, sarcoidosis, polycystic liver disease, congenital or rare hereditary liver diseases, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure accompanied by hepatic venous congestion;\n7. History of transjugular intrahepatic portosystemic shunt (TIPS);\n8. Occurrence of acute hepatitis during follow-up (defined as alanine aminotransferase levels \\>5 times the upper limit of normal) or acute-on-chronic liver failure (ACLF);\n9. Clinical or subclinical hypothyroidism or hyperthyroidism.","ALL","18 Years",{"count":19,"type":20},10000,"ESTIMATED","OBSERVATIONAL","This observational study aims to evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).",[24,25,26],"Type 2 Diabetes Mellitus (T2DM)","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Metabolic Dysfunction-associated Fatty Liver Disease",[28,29,30,31],"Type 2 Diabetes Mellitus","MASH","MAFLD","Liver inflammation index","RECRUITING","2026-06-02",{"date":35,"type":36},"2026-06-08","ACTUAL",{"date":38,"type":20},"2026-05-15",{"date":40,"type":20},"2027-12-31",{"name":42,"class":43},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",22,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100627939","an-observational-clinical-study-on-the-association-of-intestinal-ruminococcus-gnavus-and-its-derived-biogenic-amines-with-metabolic-dysfunction-associated-fatty-liver-disease-100627939","NCT07455149","An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines With Metabolic Dysfunction-associated Fatty Liver Disease","Inclusion Criteria:\n\n* 1.Healthy individuals without a history of liver disease or related underlying diseases; or patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the latest guideline, Guidelines for the Prevention and Treatment of Metabolic (Dysfunction-Associated\u002FNon-Alcoholic) Fatty Liver Disease (2024 Edition), meeting the following criteria: (i) imaging-based diagnosis of fatty liver and\u002For liver biopsy showing ≥5% macrovesicular steatosis in hepatocytes; (ii) presence of at least one component of metabolic syndrome (MetS); and (iii) exclusion of other causes of fatty liver, including excessive alcohol consumption (weekly ethanol intake ≥210 g for men and ≥140 g for women), malnutrition, hepatolenticular degeneration (Wilson's disease), and other potential etiologies.\n\n  2.Willingness to participate in this study and to sign the informed consent form.\n\n  3.Age \\>18 years.\n\nExclusion Criteria:\n\n* 1\\. History of severe organic diseases in the liver, gastrointestinal tract, kidneys, or other systems, malignant tumors, or autoimmune diseases.\n\n  2\\. Patients who have had an acute infection or inflammatory disease within the past month.\n\n  3\\. Use of laxatives, antibiotics, probiotics, prebiotics, proton pump inhibitors, or other medications that may affect the gut microbiota within the past month.",true,{"count":53,"type":20},200,"Investigating the association between intestinal Ruminococcus gnavus and its derived biogenic amines with metabolic dysfunction-associated fatty liver disease",[26],"NOT_YET_RECRUITING","2026-03-03",{"date":59,"type":36},"2026-03-06",{"date":61,"type":20},"2026-04-01",{"date":63,"type":20},"2030-10-01",{"name":65,"class":43},"Zhujiang Hospital",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":51,"sex":16,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100614864","dietary-glycine-supplementation-in-metabolic-dysfunction-associated-steatotic-liver-disease-100614864","NCT07285135","Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease","Investigating the Effects of Dietary Glycine Supplementation in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease","Inclusion Criteria:\n\nAll subjects:\n\n1. Age 21-70 years\n2. Ability to provide informed consent.\n\nMASLD group:\n\n1. Hepatic steatosis on MRI\n2. BMI of 25-50 kg\u002Fm2\n\nControls:\n\n1. Absence of hepatic steatosis on MRI\n2. BMI of 18.5-24.9 kg\u002Fm2\n3. No chronic disease\n4. No long-term medications\n\nExclusion Criteria:\n\n1. Uncontrolled diabetes (HbA1c \\> 8%)\n2. Type 1 Diabetes Mellitus\n3. Clinically significant anemia (Haemoglobin \\\u003C 10 g\u002FdL)\n4. Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis\n5. Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)\n6. Glomerular filtration rate (GFR \\\u003C 30 ml\u002Fmin)\n7. Serum alanine transaminase (ALT) \\> 3x upper limit of normal (ULN)\n8. Serum aspartate transaminase (AST) \\> 3x ULN\n9. Liver cirrhosis\n10. Significant alcohol consumption (\\> 20g\u002Fday for women and \\>30g\u002Fday for men)\n11. Receiving weight loss medications or GLP-1 receptor agonists\n12. Pregnancy\n13. Uncontrolled thyroid disease\n14. Previous bariatric surgery\n15. Weight loss \\> 5% in the past 1 month\n16. Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI\n17. Claustrophobia\n18. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other, or family members)","21 Years","70 Years",{"count":77,"type":20},60,"INTERVENTIONAL",[80],"NA","The purpose of this research study is to determine whether taking glycine, a naturally occurring amino acid, as a supplement improves liver health measurements in individuals with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).\n\nThis project will be divided into two parts. The first part will be a case-control study comparing parameters of glycine-dependent metabolic pathways between individuals with MASLD and healthy controls. The second part will be a randomized placebo-controlled trial (RCT) to evaluate the impact of 26-week dietary glycine supplementation on parameters of liver health versus 26-week placebo in patients with MASLD.",[83],"Metabolic Dysfunction Associated Fatty Liver Disease",[85,86,87],"Fatty liver","Randomized controlled trial","glycine supplements","2025-12-02",{"date":90,"type":36},"2025-12-16",{"date":92,"type":20},"2025-12",{"date":94,"type":20},"2029-01",{"name":96,"class":43},"Singapore General Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":78,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100606623","cpet-based-hiit-for-mafld-100606623","NCT07177963","CPET-based HIIT for MAFLD","Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving MAFLD","CEPHIT","Inclusion Criteria:\n\nAdults age 35\\~65 years Nonalcoholic fatty liver diagnosed by abdominal ultrasonography\n\nIn conjunction with at least one cardiometabolic risk factor:\n\n* Overweight or Obesity: ≥ 24kg\u002Fm2，or waist circumference ≥ 90 cm in men and \\> 85 cm in women, or excessive body fat mass\n* Prediabetes or type 2 diabetes mellitus: HbA1c ≥ 5.7%, or fasting plasma glucose ≥ 6.1mmol\u002FL, or 2-h plasma glucose during OGTT ≥ 7.8mmol\u002FL\n* Plasma triglycerides ≥ 1.7 mmol\u002FL (\\>-150 mg\u002Fdl) or lipid-lowering treatment\n* HDL-cholesterol ≤ -1.0 mmol\u002FL in men and ≤ -1.3 mmol\u002FL in women or lipid-lowering treatment\n* Blood pressure ≥ 130\u002F85 mmHg or treatment for hypertension\n\nExclusion Criteria:\n\n* Contraindications for Cardiopulmonary Exercise Testing\n* The electrocardiogram (ECG) results during cardiopulmonary exercise testing (CPET) showed positive findings\n* Receiving GLP-1 receptor agonists, SGLT-2i, or taking \\>2 antihypertensive\u002Fhypoglycemic\u002Flipid-lowering\u002F antiarrhythmic drugs\n* Taking dietary supplements (e.g., fish oil products, over-the-counter diet pills, meal replacements)\n* Mental illness\n* Other liver diseases\n* Movement disorder related diseases and lower limb motor injury in the past 6 months\n* Pregnant, lactating or planning to become pregnant in the near future","35 Years","65 Years",{"count":108,"type":20},54,[80],"High-intensity interval training (HIIT), as an individualized exercise training mode based on cardiopulmonary exercise testing (CPET), is characterized by high-intensity training sessions interspersed with short rest periods. The findings from recent trials suggest that in the management of metabolic dysfunction-associated fatty liver disease (MAFLD), compared with traditional aerobic exercise modes such as moderate-intensity continuous training, HIIT may achieve similar or even better effects in reducing liver fat content, increasing peak oxygen uptake, improving insulin resistance, and lowering blood pressure, despite requiring less time commitment and lower energy expenditure. However, there is currently no consensus regarding the formulation of HIIT exercise protocols.\n\nBased on the lower limits of the current mainstream HIIT intensity, sets, and interval time parameters, this study aims to assess the effectiveness, safety, and feasibility of the current exercise prescription in improving MAFLD.",[112],"Metabolic Dysfunction-Associated Fatty Liver Disease",[114,115,116,117,30],"CPET","Exercise","HITT","Peak VO2","2025-09-10",{"date":120,"type":36},"2025-09-17",{"date":122,"type":20},"2025-09-08",{"date":124,"type":20},"2026-04-30",{"name":126,"class":43},"Tang Yida",5,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":78,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":66},"100599551","efficacy-and-safety-of-calculus-bovis-sativus-in-adults-with-mafld-100599551","NCT07085962","Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD","A Randomized, Controlled Study to Evaluate the Efficacy and Safety of Calculus Bovis Sativus in Adult Subjects With Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)","Inclusion Criteria:\n\n1. Has signed the informed consent form (ICF) prior to the study and is fully aware of the study's content, procedures, and potential adverse reactions.\n2. Is able to complete the study in accordance with the protocol requirements.\n3. The subject (and\u002For partner) agrees to use effective contraceptive measures voluntarily from the screening period until 6 months after the last dose of the investigational product.\n4. At the time of signing the ICF, age is between 18 and 75 years (inclusive), with no restriction on sex.\n5. Meets the diagnostic criteria outlined in the \"Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Non-alcoholic) Fatty Liver Disease (2024 Edition)\" issued by the Chinese Society of Hepatology, Chinese Medical Association.\n6. Confirmed significant hepatic steatosis by transient elastography (Fibroscan) with a Controlled Attenuation Parameter (CAP) value ≥ 240 dB\u002Fm.\n7. Liver enzyme levels meet the following criteria: 1 × upper limit of normal (ULN) \\\u003C serum AST and ALT \\\u003C 5 × ULN.\n8. Exclusion of significant liver fibrosis based on non-invasive assessment, meeting at least one of the following four conditions:\n\n   * FIB-4 \\\u003C 1.3\n   * NAFLD Fibrosis Score (NFS) \\\u003C -1.455\n   * LSM \\\u003C 8.0 kPa\n   * FAST score \\\u003C 0.35\n9. Stable body weight for at least 6 weeks prior to screening, defined as a weight change (increase or decrease) of ≤5%.\n\nExclusion Criteria:\n\n1. Presence of the following chronic diseases: viral hepatitis; positive serology for Human Immunodeficiency Virus (HIV); primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, drug-induced liver disease, alcoholic liver disease, or Wilson's disease.\n2. Excessive alcohol consumption (defined as \\>30g of alcohol per day for males or \\>20g per day for females).\n3. History of diabetes other than type 2 diabetes, such as type 1 diabetes, secondary diabetes, etc.\n4. History of malignancy (except for those with a tumor-free period of more than 5 years prior to screening), or currently under evaluation for active or suspected malignancy. Exceptions include fully treated basal cell carcinoma, squamous cell skin carcinoma, or cervical carcinoma in situ.\n5. History of bariatric surgery within the 5 years prior to screening (inclusive).\n6. Use of antibiotics within the last 3 weeks or during the study period.\n7. Underwent major surgery within 3 months prior to signing the ICF, or planning to undergo major surgery during the study period. (Major surgery is defined as a procedure with risk to the patient's life, particularly surgery involving the cranium, chest, abdomen, or pelvic organs).\n8. Recent history of drug abuse (defined as ≤2 years).\n9. Presence of psychosis or any other cognitive impairment, or other conditions that would interfere with the subject's compliance.\n10. Currently receiving any approved therapy for MASH. Receiving anticoagulant therapy (e.g., warfarin, heparin), or participated in another interventional clinical trial with a drug product within 3 months prior to screening.\n11. Presence of any of the following laboratory exclusion criteria at screening (the study center may repeat the test once for any abnormal value):\n\n    * Serum ALT or AST \\> 5 × ULN\n    * Alkaline phosphatase (ALP) ≥ 2 × ULN\n    * eGFR \\\u003C 60 mL\u002Fmin\n    * Total bilirubin \\> 1.5 × ULN\n    * Platelet count \\\u003C lower limit of normal (LLN)\n12. Received a blood transfusion within ≤2 months prior to screening and\u002For donated blood within ≤1 month prior to screening. Note: Subjects are not permitted to donate blood throughout the entire study period.\n13. Presence of portal hypertension, such as esophageal varices, ascites, or hepatic encephalopathy.\n14. Pregnant or lactating females.\n15. History of liver transplantation or planned liver transplantation.\n16. Presence of any significant systemic or major diseases other than liver disease, including recent (≤6 months prior to screening) congestive heart failure (New York Heart Association \\[NYHA\\] Functional Classification III-IV), unstable coronary artery disease, arterial revascularization, respiratory disease, renal failure, stroke, transient ischemic attack, organ transplant, psychiatric disorders, or any other clinically significant disease-related event requiring hospitalization within 6 months prior to screening.\n17. Acute or chronic gastrointestinal diseases (including diarrhea, gastrointestinal infections, inflammatory bowel disease, etc.).\n18. Any condition that, in the opinion of the investigator, would pose a safety risk to the subject or may interfere with the conduct of the study, or if the investigator believes the subject is unlikely to complete the study or comply with its requirements.","75 Years",{"count":137,"type":20},40,[80],"Metabolic dysfunction-associated fatty liver disease (MAFLD) has become the most common chronic liver disease worldwide. Timely therapeutic intervention for MAFLD is crucial for improving patient prognosis and preventing its progression to liver fibrosis, cirrhosis, and even hepatocellular carcinoma (HCC). Therefore, the discovery of novel drugs for the treatment of MAFLD is of great significance.\n\nPrevious clinical studies have shown that calculus bovis sativus, as an adjuvant therapy for icteric hepatitis and chronic hepatitis B, exhibits significant anti-inflammatory and enzyme-reducing effects, improves liver function indicators, and enhances overall clinical outcomes. However, there is currently no clinical research on the therapeutic effects of calculus bovis sativus in patients with MAFLD, and its underlying mechanisms of action remain to be elucidated.\n\nThis study proposes a randomized, double-blind, placebo-controlled trial to investigate the effects of calculus bovis sativus in adult patients with MAFLD. The primary objective is to preliminarily explore the clinical efficacy of calculus bovis sativus in treating MAFLD, particularly its impact on liver injury and inflammation. Furthermore, this research will employ a multi-omics approach, integrating metagenomics and metabolomics, to analyze the effects of calculus bovis sativus on the gut microbiota and their metabolites in MAFLD patients. The aim is to uncover its potential mechanisms of action, thereby facilitating its clinical translation and application, and ultimately providing a new therapeutic strategy for patients with MAFLD.",[26],[142,143,144],"metabolic dysfunction-associated fatty liver disease","Calculus bovis sativus","Hypertransaminasemia","2025-07-17",{"date":147,"type":36},"2025-07-25",{"date":149,"type":20},"2025-08-01",{"date":151,"type":20},"2026-07-31",{"name":153,"class":43},"Huazhong University of Science and Technology",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":66},"100588297","an-observational-study-of-inflammatory-bowel-disease-ibd-patients-with-non-alcoholic-fatty-liver-disease-nafld-100588297","NCT06939569","An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)","A Bidirectional, Multicenter Cohort Study of Inflammatory Bowel Disease (IBD) Patients With Nonalcoholic Fatty Liver Disease (NAFLD)","Inclusion Criteria:\n\n1. Subjects aged over 18 years (including borderline values), of either sex.\n2. Subjects consistented with the Chinese consensus on the diagnosis and treatment of IBD;\n3. Subjects able to cooperate with follow-up, participate in this study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Subjects with incomplete clinical data;\n2. Subjects can not to cooperate with follow-up, and refuse to sign the informed consent;\n3. Subjects can not to cooperate with the completion of relevant examinations; 4 Pregnant women;\n\n5.Subjects with severe heart, lung, kidney and other organ diseases or cancer, and expected survival time less than 6 months.",{"count":162,"type":20},337,"Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Mesenteric adipose tissue hyperplasia indicates disease activity in IBD patients, and abnormal lipid metabolism plays an important role in the pathogenesis of IBD.\n\nIn addition to intestinal symptoms, nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction associated fatty liver disease (MASLD), has become the most common extraintinal manifestation in IBD patients. What are the similarities and differences between IBD patients with and without MASLD? Does the occurrence and severity of MASLD affect the clinical efficacy of IBD and increase the adverse outcome of IBD? There are no relevant studies to date. We have previously completed the construction of a cohort of 290 IBD patients using the IBD patient database and biobank of Dongfang Hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on IBD disease activity. Based on this cohort, multi-center cooperation was carried out to establish an IBD research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. The clinical characteristics of IBD patients with MASLD were analyzed. logistic regression, COX regression, Kaplan-Meier survival curve and other methods were used. To investigate the effect of MASLD on the clinical efficacy and prognosis of inflammatory bowel disease (IBD). This project will provide efficient, full and reliable research-grade data with Chinese characteristics for IBD clinical research, and improve the level of regional diagnosis and treatment.",[165,83],"Inflammatory Bowel Disease (IBD)","2025-04-20",{"date":168,"type":36},"2025-04-23",{"date":170,"type":20},"2025-05-01",{"date":172,"type":20},"2027-12-01",{"name":174,"class":43},"Shanghai East Hospital",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":66},"100514162","association-of-hscar-with-mafld-and-liver-fibrosis-a-cross-sectional-study-100514162","NCT05974904","Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study","Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study","Inclusion Criteria:\n\n* Total participants from NHANES 2017-2020\n* Participants diagnosed with MAFLD. Metabolic dysfunction-associated fatty liver disease (MAFLD) is the term used to describe hepatic steatosis in the presence of metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus.\n\n  1. Diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) HbA1c ≥ 6.5% (48 mmol\u002Fmol); (3) fasting plasma glucose ≥ 7.0 mmol\u002FL (126 mg\u002FdL); (4) 2-hour plasma glucose (2hPG) ≥ 11.1 mmol\u002FL (200 mg\u002FdL).\n  2. Overweight or obesity: defined as BMI≥25 kg\u002Fm2 in Caucasians or BMI≥23 kg\u002Fm2 in Asians\n  3. If presence of at least two metabolic risk abnormalities:\n\n     * Waist circumference≥102\u002F88 cm in Caucasian men and women (or≥90\u002F80 cm in Asian men and women)\n     * Blood pressure≥130\u002F85 mmHg or specific drug treatment\n     * Plasma triglycerides≥150 mg\u002Fdl (≥1.70 mmol\u002FL) or specific drug treatment\n     * Plasma HDL-cholesterol \\\u003C40 mg\u002Fdl (\\\u003C1.0 mmol\u002FL) for men and \\\u003C50 mg\u002Fdl (\\\u003C1.3 mmol\u002FL) for women or specific drug treatment\n     * Prediabetes (i.e., fasting glucose levels 100 to 125 mg\u002Fdl \\[5.6 to 6.9 mmol\u002FL\\], or 2-hour post-load glucose levels 140 to 199 mg\u002Fdl \\[7.8 to 11.0 mmol\\] or HbA1c 5.7% to 6.4% \\[39 to 47 mmol\u002Fmol\\])\n     * Homeostasis model assessment of insulin resistance score≥2.5\n     * Plasma high-sensitivity C-reactive protein level \\>2 mg\u002FL\n\nExclusion Criteria:\n\n* Liver ultrasound data not available\n* participants without complete clinical data\n* participants under 18 years old\n* participants with cancer.","90 Years",{"count":184,"type":20},7000,"The goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD).\n\nThe main question\\[s\\] it aims to answer are:\n\n\\[question 1\\] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD? \\[question 2\\] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?",[26,187,188],"Hepatic Steatosis","Liver Fibrosis",[190,142,191,192,193,194],"high-sensitivity C-reactive protein to albumin ratio","National Health and Nutrition Examination Survey","control attenuation parameter","liver stiffness measurement","inflammation","2025-02-10",{"date":197,"type":36},"2025-02-12",{"date":199,"type":36},"2023-07-18",{"date":201,"type":20},"2026-12-28",{"name":203,"class":43},"Chongqing Medical University",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":211,"targetDuration":4,"studyType":78,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100575510","the-efficacy-and-safety-of-chiglitazar-in-patients-with-mafld-related-cirrhosis-100575510","NCT06773221","The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis","A Key Therapeutic System for Reversing MAFLD-related Cirrhosis: a Randomized Double-blind Controlled Trial on the Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis","Inclusion Criteria:\n\n1\\. Men and women aged between 18 and 75 years (inclusive) who understand and sign informed consent forms; 2. Compensated MAFLD-related cirrhosis diagnosis(meet one of the following conditions):\n\n1. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatohepatitis according to the Non Alcoholic Fatty Liver Disease Clinical Research Network (NASH-CRN) scoring system, and there is no evidence of competitive aetiology.\n2. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatosis (no steatohepatitis) according to NASH-CRN scoring system, and there is no evidence of competitive aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and\u002For type 2 diabetes mellitus (T2DM).\n3. Historical biopsy showed steatohepatitis, and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There is at least 1 coexisting or history of metabolic comorbidity.\n4. Historical biopsy showed steatosis (no steatohepatitis), and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (5)-1)). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and\u002For T2DM.\n5. In the absence of biopsy, MAFLD-related cirrhosis is defined based on the following criterias:\n\n   a. Cirrhosis is defined based on one of the following non-invasive tests(NITS): i: MRE ≥ 5kPa or VCTE-LSM ≥ 20kPa (when the patients with BMI ≥ 28kg\u002Fm2 , MRE ≥ 5kPa must also be met); ii:VCTE ≥15 kPa and \\\u003C20 kPa and 1 of the following: MRE≥4.45kPa or Agile4≥0.565 or Platelets≤150,000\u002FµL; iii: VCTE \\\u003C15 kPa and 2 of the following: MRE≥4.45kPa or Agile4≥0.565 or Platelets≤150,000\u002FµL; b. Current or previous imaging examinations have diagnosed fatty liver or controlled attenuation parameter (CAP)\\>288dB\u002Fm or magnetic resonance imaging proton density fat fraction (MRI-PDFF)\\>5%.\n\n   c. There is no evidence of competing aetiology; d. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and\u002For T2DM.\n6. If a participant's MAFLD-related cirrhosis diagnosis for eligibility is based on the biopsy screening period , no weight loss of ≥10% should have occurred in the same time period (based on medical history).\n\nExclusion Criteria:\n\n1. Other chronic liver diseases (including but not limited to viral hepatitis, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.)\n2. There has been a continuous history of heavy drinking for 3 months or more current or rencent 5 years (heavy drinking is defined as \\>20 g\u002Fday in women and \\>30 g\u002Fday in men); Or researchers can not reliably quantify alcohol consumption.\n3. Hepatic decompensation events (including ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, etc.) or hepatocellular carcinomaor.\n4. History of malignant tumors within 5 years (excluding local squamous cell carcinoma of the skin or treated cervical intraepithelial neoplasia)；\n5. Combination of autoimmune diseases (including but not limited to systemic lupus erythematosus, multiple sclerosis, Hashimoto's thyroiditis, etc.)；\n6. Combined with severe esophageal and gastric varices and\u002For positive red sign accessed by endoscope；\n7. History of liver transplantation or bone marrow transplantationor or listed for liver transplantation;\n8. Previous (\\\u003C5 years before screening)or planned (during the trial period) treatment for obesity with surgery;\n9. Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) genetic diseases;\n10. Secondary factors that can cause liver steatosis, such as malnutrition, medication, genetic metabolic diseases, etc.\n11. Individuals with the following abnormal indicators:\n\n    1. Alanine aminotransferase (ALT)\\>5 \\* ULN;\n    2. Aspartate aminotransferase (AST)\\>5 \\* ULN\n    3. Direct bilirubin (DBIL)\\>1.5 \\* ULN\n    4. Estimated glomerular filtration rate (eGFR)\\\u003C60 mL\u002Fmin\u002F1.73m2\n    5. Glycated hemoglobin (HbA1c)\\>10%\n    6. MELD score ≥ 12 or Child Pugh score ≥ 8 caused by liver disease\n12. History of any type of diabetes than T2DM;\n13. Participants receive more than 1 month of treatment with any of the following drugs within 6 months before screening: thiazolidinedione (TZD), glucagon like peptide-1 (GLP-1) receptor agonists, bate lipid-lowing drugs, liver selective thyroxine receptor beta (TSH - β) agonists, obeticolic acid, insulin, berberine, weight-loss drugs, amiodarone, methotrexate, systemic glucocorticoids at \\>5 mg\u002Fday of prednisone equivalent, tamoxifen, oestrogens at doses higher than those used for hormone replacement or contraception, anabolic steroids except testosterone replacement, valproic acid, and known hepatotoxins;\n14. Participants receive the following medications unless they have received a stable dose of at least 1 month prior to screening: beta blockers, thiazide diuretics, statins, niacin, ezetimibe, thyroid hormones, metformin, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium glucose cotransporter (SGLT-2) inhibitors, sulfonylureas, gliptides, alpha glucosidase inhibitors;\n15. Participating in clinical trials of other drugs or medical devices within the past 3 months.\n16. Participants who demonstrate recent evidence (within 6 months prior to screening) of acute or unstable cardiovascular and cerebrovascular events events (such as hospitalisation for myocardial infarction, stroke, chronic heart failure grade IV (NYHA classification), severe arrhythmia, left ventricular hypertrophy, transient ischemic attack, and\u002For acute peripheral vascular events);\n17. QTc (Fridericia) mean interval that is greater than 500 ms at screening (triplicate electrocardiogram \\[ECG\\]) or personal or family history of long QT syndrome;\n18. Have a history of major surgery or fracture in the past 3 months;\n19. Severe osteoporosis or other known bone diseases, or other conditions that may lead to fractures accessed by researchers;\n20. History of lower limb or systemic edema;\n21. Contraindications for MRI scans, including but not limited to: cerebral aneurysm clips, implanted nerve stimulators, implanted pacemakers or defibrillators, or the presence of artificial heart valves, cochlear implants, potentially ferromagnetic intraocular foreign bodies (such as metal shavings), other implantable medical devices (such as insulin pumps), metal shrapnel or bullets remaining in the body, severe claustrophobia, tattoos (determined by the researcher and radiologist), weight exceeding the carrying capacity of the MRI scanner, etc.;\n22. Positive for human immunodeficiency virus (HIV) infection;\n23. History of drug use or abuse of drugs within the 12 months prior to screening.\n24. patients who have smoked heavily within the past year, with a daily intake of ≥ 30 cigarettes;\n25. Pregnant or lactating women, and the woman of childbearing age who are unable or unwilling to use adequate contraception;\n26. Researchers believe that patients who are not suitable to participate in this study.",{"count":212,"type":20},195,[80],"A total of 195 adult patients with biopsy-proven or clinically diagnosed metabolic dysfunction-associated with fatty liver disease(MAFLD)-related cirrhosis will be randomly divided into two arms. One arm will receive Chiglitazar(64 mg) treatment, while the other arm will receive placebo treatment, lasting for 72 weeks. Both the researchers and the participants will be blinded. The primary outcome is the reversal rate of cirrhosis assessed by magnetic resonance elastography. Secondary outcomes include outcome events, changes in histopathological fibrosis stage, non-invasive fibrosis tests, glucose and lipid metabolism indicators.",[83,216],"Compensated Liver Cirrhosis","2025-01-13",{"date":219,"type":36},"2025-01-15",{"date":221,"type":20},"2025-02-05",{"date":223,"type":20},"2028-06-30",{"name":225,"class":43},"Beijing Friendship Hospital",4,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":78,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":248,"leadSponsor":250,"locationsCount":66},"100573701","effect-of-high-protein-diet-on-hepatic-steatosis-in-patients-with-mafld-100573701","NCT06749704","Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD","Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial","Inclusion Criteria:\n\n* Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP \\>250, BMI\\>23 and\u002For DM) Age 18-65 years\n\nExclusion Criteria:\n\n* • Lean (BMI \\\u003C23) patients\n\n  * Age \\\u003C18 and \\>65 years\n  * Individuals who had been hospitalized with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months\n  * Patients with viral hepatitis\n  * Patients with significant alcohol consumption (regular consumption of \\> 10g per day for females and \\> 20g\u002Fd in males),\n  * Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded\n  * Pregnant \\& lactating women","60 Years",{"count":236,"type":20},140,[80],"MAFLD is a growing problem in India. Its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is the cornerstone of management. The ideal macronutrient distribution within a hypocaloric diet is not known yet. Evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.",[83],[241,242,243],"mitochondrial dysfunction","metabolic inflexibility","FGF21 resistance","2024-12-24",{"date":246,"type":36},"2024-12-27",{"date":246,"type":20},{"date":249,"type":20},"2027-05-01",{"name":251,"class":43},"Institute of Liver and Biliary Sciences, India",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":267,"leadSponsor":268,"locationsCount":66},"100572904","thyroid-dysfunction-and-its-association-with-metabolic-dysfunction-associated-fatty-liver-disease-100572904","NCT06739330","Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Both sexes.\n* Patients with metabolic dysfunction-associated fatty liver disease (MAFLD).\n\nExclusion Criteria:\n\n* History of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer, hypothyroidism, and hyperthyroidism).\n* Patients with alcoholic liver disease take more than 40g of alcohol (or four units) per day.\n* Viral hepatitis.\n* Pregnant women.",{"count":259,"type":20},150,"This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.",[262,112],"Thyroid Dysfunction","2024-12-19",{"date":265,"type":36},"2024-12-20",{"date":263,"type":36},{"date":170,"type":20},{"name":269,"class":43},"Tanta University",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":279,"conditions":280,"keywords":284,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":66},"100557670","positive-association-of-us-fli-with-the-severity-of-cad-100557670","NCT06541132","Positive Association of US-FLI With the Severity of CAD","Positive Association Between Ultrasonographic Fatty Liver Indicator and the Severity of Coronary Artery Disease","Inclusion Criteria:\n\n* Patients older than 18 years old\n* Patients underwent ICA due to chest pain, chest tightness or other reasons in our hospital from August 2022 to December 2023 were included in our study\n\nExclusion Criteria:\n\n* Incomplete clinical data\n* previous coronary stent implantation\n* no abdominal ultrasound examination\n* poor ultrasound image quality\n* congenital heart disease\n* tumor\n* thyroid diseases and infectious diseases",{"count":278,"type":20},190,"As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Our study aims to explore the relationship between US-FLI based on MAFLD and the severity of CHD.",[281,26,282,283],"Coronary Artery Disease of Significant Bypass Graft","SYNTAX Score","Ultrasonography",[285,26,286,283],"Coronary Artery Disease","SYNTAX score","2024-08-19",{"date":289,"type":36},"2024-08-21",{"date":291,"type":36},"2022-07-01",{"date":293,"type":20},"2025-04-28",{"name":203,"class":43},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":303,"targetDuration":4,"studyType":78,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":316,"leadSponsor":318,"locationsCount":4},"100526503","study-on-mafld-related-cirrhosis-prevention-and-treatment-strategies-100526503","NCT06135584","Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies","Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies","SMART","Inclusion Criteria:\n\n1. Age 18-75 years old, gender and ethnicity are not limited;\n2. Meet the diagnostic criteria for MAFLD;\n3. F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;\n4. Be willing to sign informed consent.\n\nExclusion Criteria:\n\n1. Cirrhosis due to any chronic liver disease other than MAFLD (including but not limited to alcohol or drug abuse, medications, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency);\n2. Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;\n3. According to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (Note: Heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects).\n4. Use of NAFLD-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.",{"count":304,"type":20},1000,[80],"To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis\u002Fcirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.",[26,308],"Cirrhosis",[310,311],"Treatment Strategies","Multicenter Real-World Study","2023-11-15",{"date":314,"type":36},"2023-11-18",{"date":314,"type":20},{"date":317,"type":20},"2026-12-31",{"name":319,"class":43},"The Affiliated Hospital of Hangzhou Normal University"]