[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steatosis-of-liver\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steatosis-of-liver":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,76,102,130,163,186,206],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100641888","impact-of-steatotic-liver-disease-associated-with-metabolic-dysfunction-masld-on-frailty-cognition-and-quality-of-life-a-gender-sensitive-approach-towards-a-comprehensive-and-equitable-perspective-100641888",false,"NCT07652892","Impact of Steatotic Liver Disease Associated With Metabolic Dysfunction (MASLD) on Frailty, Cognition, and Quality of Life. A Gender-sensitive Approach Towards a Comprehensive and Equitable Perspective.","IIBSP-MAS-2025-133","MASLD","Inclusion Criteria:\n\n* Patients will be included who are able to provide informed consent and actively participate in periodic assessments.\n\nExclusion Criteria:\n\n* Risky alcohol consumption:\n\n\\> 30 g\u002Fday in men and \\> 20 g\u002Fday in women. AUDIT score: \\> 7 points in men, \\> 5 in women.\n\n* Other liver diseases (viral hepatitis, autoimmune hepatitis, etc.).\n* Advanced neurodegenerative diseases or severe psychiatric disorders.\n* Severe comorbidities or treatments that, in the researchers' judgment, may affect frailty and quality of life more than metabolic syndrome and liver disease.","ALL","20 Years","80 Years",{"count":21,"type":22},140,"ESTIMATED","12 Months","OBSERVATIONAL","The goal of this observational study is to determine the differences in the prevalence, characteristics and evolution of frailty between men and women diagnosed with MASLD, and to establish its relationship with clinical, functional, hormonal and social parameters.",[27],"Steatosis of Liver",[29],"A condition characterized by the accumulation of fat in the liver, which is closely linked to metabolic disorders and occurs with low or no alcohol consumption.","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":22},"2026-05-26",{"date":38,"type":22},"2028-05-25",{"name":40,"class":41},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100594013","fructose-is-a-metabolic-and-inflammatory-pathogenic-factor-in-metabolic-dysfunction-associated-steatohepatitis-mash-100594013","NCT07013916","Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)","FLOURISH","Inclusion Criteria:\n\n* Able and willing to give written informed consent\n* Age 45-65 at consent\n* HbA1c \\\u003C 48 mmol\u002Fmol\n* Overweight and stage I obesity using BMI thresholds adjusted for ethnicity:\n\n  * 23.0kg\u002Fm2 - 32.4kg\u002Fm2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations\n  * 25kg\u002Fm2 - 34.9kg\u002Fm2 in White populations\n\nMASH Patients:\n\nClinical diagnosis of MASH and F2 - F3 fibrosis:\n\nEither:\n\nLiver biopsy within 12 months of baseline\n\nOr:\n\n• History of histologically-diagnosed MASH with current evidence of fatty liver, AST\\>20 and Fibroscan CAP≥248 dB\u002Fm and stiffness 9.5kPa -14kPa\n\nOr:\n\n• FAST score \\>0.67\n\nPatients with steatosis:\n\n• defined by Fibroscan CAP≥248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nHealthy controls:\n\n• defined by Fibroscan CAP\\\u003C248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent\n* Age \\\u003C45 or \\>65\n* Any form of diabetes mellitus\n* Currently pregnant\n* Known fructose intolerance or food allergy\n* Diagnosis of cirrhosis or Fibroscan stiffness \\>14kPa\n* Current Child-Pugh B\u002FC or episode of decompensation in last year\n* Non-MASLD liver disease known to participant (including viral hepatitis, auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, sarcoidosis, cystic fibrosis, sickle cell disease)\n* Regular alcohol intake \\> 14 units a week for females and \\>21 units a week for males (participant-reported)\n* Smoking, vaping or use of nicotine-containing products within the last month\n* Taking prohibited medication:\n\n  * Probiotic or antibiotic use within last 4 weeks (Note: participants will be considered eligible if they have undergone a 4-week washout from probiotics or 4-weeks after discontinuing antibiotic use)\n  * any oral steroids within the last 6 weeks\n  * current, or within 3 months, use of immunosuppressive medication\n  * Amiodarone, nitrofurantoin, or anti-fungals within 3 months\n  * Use of anti-obesity medication - orlistat or GLP-1 receptor agonist-containing treatments within 6 months\n  * Use of vitamin E, pioglitazone or other medication for MASH including current or within 3 months enrolment in clinical trial unless documented to have been on placebo\n* History of malignancy (except basal cell carcinoma), or medication for malignancy within the last 2 years\n* Any major organ transplant (excluding corneal or hair)\n* Clinical diagnosis of chronic kidney disease 3 or above, or of heart failure (NYHA 3 or 4)\n* COPD requiring home oxygen\n* Known eating disorder (e.g. anorexia nervosa) or severe mental illness (e.g. schizophrenia)\n* Investigator opinion that study is unsuitable for patient",true,"45 Years","65 Years",{"count":54,"type":22},72,"INTERVENTIONAL",[57],"NA","MASLD (Metabolic dysfunction-associated steatotic liver disease) is a condition where fat builds up in the liver. It is the most common cause of liver disease worldwide. In some people, the fat can irritate the liver (inflammation) and cause damage. This is a more serious condition called MASH (Metabolic dysfunction-associated steatohepatitis). People with MASH more at risk of liver cirrhosis (advanced scarring in the liver) and liver cancer.\n\nIt is not fully understood why MASLD becomes MASH, or why this happens in some people but not in others. However, it is known that our diet plays a role. Research shows a diet high in a type of sugar called fructose might make MASLD worse. Fructose is found in fruit, honey and table sugar, and lots of processed food and drinks. The body deals with fructose differently to other sugars, which is why fructose may be a problem. Although scientists have studied the effects of fructose in healthy people, no studies so far have included people with MASH, so it is not known if fructose might make the condition worse.\n\nTo answer this question, the researchers will conduct a four-week randomised, double-blind study to compare the effects of fructose with another sugar called glucose in 36 people with MASH, 18 people with 'simple' MASLD, and 18 controls without liver disease. Participants will follow a low-sugar diet and, after 14 days on this diet, they will add either a glucose or fructose supplement for another 14 days. Participants will attend 3 study visits, where blood, urine, stool, and saliva samples will be taken. The main question is whether fructose causes more inflammation in people with MASH compared to those with MASLD, or people without liver disease. The researchers will also investigate how fructose affects liver fat content, the gut microbiota, and other processes relevant to MASLD\u002FMASH.",[60,61,27],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","MASH With Fibrosis",[63,64,15,65,66],"fructose","MASH","liver","inflammation","2025-07-18",{"date":69,"type":34},"2025-07-23",{"date":71,"type":34},"2025-06-30",{"date":73,"type":22},"2026-04-01",{"name":75,"class":41},"Queen Mary University of London",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":24,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100563433","quantitative-ct-imaging-parameters-for-assessing-hepatic-steatosis-in-chb-100563433","NCT06616103","Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB","Utility of Quantitative Imaging Parameters from Deep Learning-based CT Segmentation in Assessing Hepatic Steatosis and Fibrosis in Chronic Hepatitis B: a Prospective Study Using MRI As the Reference Standard","Inclusion Criteria:\n\n* chronic hepatitis B\n* no chronic liver disease other than chronic hepatitis B\n* Body mass index \\>= 23\n\nExclusion Criteria:\n\n* pregnant women\n* unable to perform MRI examinations due to claustrophobia or metallic foreign body\n* suspicious hepatic malignancy on previous imaging studies\n* history of local treatment for hepatic lesions\n* history of surgery or catheter insertion of liver or spleen","19 Years",{"count":85,"type":22},111,"1 Year","This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis.",[89,27,90],"Chronic Hepatitis B","Fibrosis and Cirrhosis of Liver","NOT_YET_RECRUITING","2024-09-24",{"date":94,"type":34},"2024-09-27",{"date":96,"type":22},"2024-09-26",{"date":98,"type":22},"2025-08-31",{"name":100,"class":41},"Seoul National University Hospital",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":55,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":101},"100557388","ketogenic-diet-in-masld-related-cacld-100557388","NCT06537466","Ketogenic Diet in MASLD-related cACLD","A Randomised Controlled Tria of Low-calorie Ketogenic Diet Versus Mediterranean Diet in Patients With Compensated Advanced Chronic Liver Disease (cACLD) Secondary to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Inclusion Criteria:\n\n1. Patients older than 18 years\n2. Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and\u002For fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor.\n3. Informed consent form obtained before any trial-related ac.vity.\n\nExclusion Criteria:\n\n1. Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA\\<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \\<1:160), . .\n2. MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g\u002Fwk and 210-420 g\u002Fwk for females and males, respectively.\n3. History of or planned gastrointestinal bypass or any additional bariatric surgery\u002Fintervention.\n4. Recent significant weight loss ( \\> 5 % within previous 6 months)\n5. Presence of large esophageal varices (F2 or F3)\n6. Decompensated liver cirrhosis and\u002For presence of hepatocarcinoma and\u002For portal thrombosis.\n7. Be pregnant or breasxeeding.\n8. Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\\<30 ml\u002Fmin).\n9. Therapy with SGLT-2 inhibitors and\u002For GLP-1 agonist started within 6 months of screening visit.\n10. Recent (within 6 months of screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid)\n11. Any additional condition that might interfere with optimal participation in the study, according to investigators opinion","18 Years",{"count":111,"type":22},50,[57],"The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.",[115,27,116],"Steatohepatitis, Nonalcoholic","Cirrhosis, Liver",[118,119,120],"Steatohepatitis","Steatosis","Ketogenic diet","2024-07-31",{"date":123,"type":34},"2024-08-05",{"date":125,"type":22},"2024-11",{"date":127,"type":22},"2026-11",{"name":129,"class":41},"University of Palermo",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":138,"enrollmentInfo":139,"targetDuration":141,"studyType":24,"phases":4,"briefSummary":142,"conditions":143,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":162},"100489331","global-research-initiative-for-patients-screening-on-mash-100489331","NCT05651724","Global Research Initiative for Patients Screening on MASH","Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway","GRIPonMASH","Inclusion Criteria:\n\n* Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.\n* Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, should have had a prior diagnosis based on study definitions.\n\nStudy definitions:\n\nType 2 diabetes mellitus\n\n* At least 2 times a fasting glucose \\> 7,0 mmol\u002FL\n* Or elevated non-fasting glucose \\>11,1 mmol\u002FL 2 hrs after OGTT\n* Or HbA1c ≥48 mmol\u002Fmol (≥6.5%)\n* Or being actively treated for previously diagnosed type 2 diabetes by a health care provider\n\nObesity\n\n* Body mass index (BMI) \\> 30\n* Or waist circumferences Caucasian: male ≥ 94 cm, female ≥ 80 cm South-Asian\u002FChinese: male ≥90 cm, female ≥80 cm Japanese: male ≥85 cm, female ≥90 cm\n\nArterial hypertension\n\n* Systolic BP ≥ 140 mmHg and\u002For diastolic BP ≥ 90 mmHg\n* Or being actively treated for previously diagnosed arterial hypertension by a health care provider\n\nMetabolic syndrome\n\n\\- Central obesity defined as waist circumference (see above), if BMI is \\>30 kg\u002Fm2, central obesity can be assumed and waist circumference does not need to be measured\n\nAND any two of the following:\n\n* Raised triglycerides: ≥ 150 mg\u002FdL (1.7 mmol\u002FL), or specific treatment for this lipid abnormality\n* Reduced HDL cholesterol: \\\u003C 40 mg\u002FdL (1.03 mmol\u002FL) in males, \\\u003C 50 mg\u002FdL (1.29 mmol\u002FL) in females, or specific treatment for this lipid abnormality\n* Raised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension\n* Raised fasting plasma glucose (FPG): FGP ≥ 100 mg\u002FdL (5.6 mmol\u002FL), or previously diagnosed type 2 diabetes (if above \\>5.6 mmol\u002FL or 100 mg\u002FdL, an oral glucose tolerance test is strongly recommended, but is not necessary to define presence of the syndrome)\n\nExclusion Criteria:\n\n* The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, sarcoidosis, Wilson's disease etc);\n* The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;\n* The patient engages in (excessive) alcohol use: \\> 3 units\u002Fday in males \\[30 grams\u002Fday\\] and \\> 2 units\u002Fday in females \\[20 grams\u002Fday\\];\n* The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient's safety or ability to be included in this study;\n* The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel;\n* The patient is not able to understand the details of the protocol and\u002For is not able to provide written informed consent;\n* The patient is pregnant or breastfeeding.\n* The patient underwent bariatric surgery in the last 12 months.","75 Years",{"count":140,"type":22},10000,"5 Years","GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.",[64,15,61,144,27,145,146,147,148],"Fibrosis, Liver","Type 2 Diabetes","Obesity","Metabolic Syndrome","Arterial Hypertension",[15,64,150,151],"Screening","Patient care pathway","2024-07-30",{"date":154,"type":34},"2024-08-01",{"date":156,"type":34},"2023-06-30",{"date":158,"type":22},"2031-03-31",{"name":160,"class":161},"Julius Clinical","INDUSTRY",13,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":55,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":101},"100554726","phase-1-effect-of-4-weeks-of-oral-d-piger-on-safety-pharmacokinetics-and-ethanol-metabolism-in-overweight-individuals-2023-100554726","NCT06502834","Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)","PIGER","Inclusion:\n\nMale or (postmenopausal) females\n\n* Increased waist circumference (\\>102 cm men, 88\\>cm women)\n* Insulin resistance (HOMA\\>2.5)\n* 18-70 years\n\nExclusion Criteria:\n\n* Use of systemic medication (except for paracetamol), including antibiotics and pro-\u002Fprebiotics in the past three months or during the study period.\n* A history of a cardiovascular event\n* A history of cholecystectomy\n* Overt untreated gastrointestinal disease or abnormal bowel habits\n* Liver enzymes\\>2.5 fold higher than the upper limit of normal range\n* Smoking\n* Alcohol abuse","70 Years",{"count":172,"type":22},20,[174],"PHASE1","The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.\n\nThe investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.",[146,147,27],"2024-07-15",{"date":179,"type":34},"2024-07-16",{"date":181,"type":34},"2024-05-01",{"date":183,"type":22},"2024-12-01",{"name":185,"class":41},"Max Nieuwdorp",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":50,"sex":17,"minAge":109,"maxAge":138,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":4},"100550911","assessment-the-diagnostic-value-of-pro-neurotensin-as-a-serum-biomarker-in-masld-100550911","NCT06453239","Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in MASLD","Assessment the Diagnostic Value of Pro-Neurotensin as a Serum Biomarker in Metabolic Dysfunction-associated Steatotic Liver Disease","Inclusion Criteria:\n\n* Asymptomatic adults were randomly recruited from relatives of patients in Tropical Medicine and Gastroenterology Outpatient Clinic or the Inpatient Section of the department. Participants were categorized as MASLD patients if their abdominal US examination showed the criteria of fatty liver as described later or Non-MASLD (Controls) if they did not show these criteria.\n\nExclusion Criteria:\n\n* (i) Patients aged \\\u003C18 years or \\>75 years. (ii) History of Alcohol consumption. (iii) A diagnosis of liver diseases other than MASLD, including viral hepatitis, drug-induced liver injury, clinically suspected cases of autoimmune liver disease, Wilson's diseases, primary biliary cholangitis.\n\nThe control group had no illness to cause any inflammation; no usage of alcohol, drug, or herbal substances; no history of previous liver diseases; and was negative for viral hepatitis serology tests and had completely normal liver US.",{"count":194,"type":22},80,"To assess the diagnostic significance of serum pro-NT in MASLD and ability to differentiate between early and advanced steatosis.",[27],"2024-06-05",{"date":199,"type":34},"2024-06-11",{"date":201,"type":22},"2024-07",{"date":203,"type":22},"2025-08",{"name":205,"class":41},"Sohag University",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":212,"enrollmentInfo":213,"targetDuration":214,"studyType":24,"phases":4,"briefSummary":215,"conditions":216,"keywords":225,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100396456","the-european-nafld-registry-100396456","NCT04442334","The European NAFLD Registry","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinically suspected NAFLD based on any of:\n\n   1. Patient with historical liver biopsy providing histological evidence of NAFLD or,\n   2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and\u002For radiological findings consistent with NAFLD or,\n   3. Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':\n\n      * Increased waist circumference by ethnically adjusted criteria (e.g. Europid male\u002Ffemale ≥94cm\u002F80cm) or overweight\u002Fobese (BMI ≥25);\n      * Raised fasting glucose ≥100 mg\u002FdL \\[5.6 mmol\u002FL\\], HbA1c ≥48mmol\u002Fmol (6.5%) or previously diagnosed insulin resistance\u002Ftype 2 diabetes mellitus (or on treatment);\n      * Dyslipidaemia (fasting TG level ≥150 mg\u002FdL \\[1.7 mmol\u002FL\\]; or fasting HDL \\\u003C40 mg\u002FdL \\[1.03 mmol\u002FL\\] in males and \\\u003C50 mg\u002FdL \\[1.29 mmol\u002FL\\] in females; or on treatment);\n      * Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).\n3. Average alcohol consumption less than 21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.\n\nExclusion Criteria\n\n1. Refusal or inability (lack of capacity) to give informed consent.\n2. Average alcohol ingestion greater than approximately 21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n3. History or presence of Type 1 diabetes mellitus.\n4. Presence of any other form of chronic liver disease except NAFLD.\n5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).\n6. Any contra-indication to liver biopsy.\n7. Recent (within 3 months) change in dose\u002Fregimen or introduction of Vitamin E (at a dose ≥400 IU\u002Fday), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.\n8. Non-English speaking\u002Funable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated.\n9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.","100 Years",{"count":140,"type":22},"10 Years","The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and\u002For from NAFL through NASH to fibrosis and cirrhosis.",[217,218,219,144,27,220,221,145,222,223,146,224],"NAFLD","NASH","NASH - Nonalcoholic Steatohepatitis","Hepatocellular Carcinoma","Cardiovascular Diseases","Dyslipidaemia","Hypertension","Other Associated Comorbidities",[217,218,118,226,227,228],"Liver","Cirrhosis","Non-alcoholic fatty liver disease","2023-01-05",{"date":231,"type":34},"2023-01-06",{"date":233,"type":34},"2015-05-01",{"date":235,"type":22},"2030-12-31",{"name":237,"class":41},"Newcastle University",37]