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Fatty Liver clinical trials

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NCT ID: NCT04707651 Recruiting - Clinical trials for Steatohepatitis, Nonalcoholic

Formula Diet Treatment for NASH Patients.

NASH
Start date: January 18, 2021
Phase: N/A
Study type: Interventional

Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.

NCT ID: NCT04697810 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Start date: December 10, 2021
Phase: Phase 2
Study type: Interventional

Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.

NCT ID: NCT04679376 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Statins for the Treatment of NASH

STAT NASH
Start date: January 25, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine whether the study drug, atorvastatin (Lipitor®), is safe and effective in improving the features of NASH.

NCT ID: NCT04671966 Recruiting - Heart Diseases Clinical Trials

Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction

Start date: September 13, 2018
Phase: Phase 4
Study type: Interventional

To test the specific research questions, healthy men and age-matched healthy premenopausal females will be enrolled. Subjects will undergo cardiac magnetic resonance imaging and spectroscopy (MRI/MRS) to evaluate cardiac morphology/function and fat metabolism. To acutely elevate myocardial triglyceride content, subjects will be asked to abstain from eating for 2 days (reproducibly causes a significant and physiological increase in myocardial fat deposition, transiently). Subjects will be allowed water and/or an isotonic saline solution in order to maintain hydration status. After screening, subjects will meet with the research coordinator or an investigator for a discussion, with opportunity for questions, before applicable consent forms are obtained. The subject will be screened for metal in or on their body and claustrophobia using a standard MR screening form. A venous blood sample will be taken for measurement of metabolic health, circulating hormones, and systemic inflammation. Imaging will include cine imaging for global morphology and function, tissue tagging for regional tissue deformation, spectroscopy for fat quantification. After baseline images of the heart are obtained, the subject will be asked to squeeze a MR-safe handgrip dynamometer at 30% of their maximum while images of the heart are obtained. Blood pressure will also be measured at rest and during stress. Each MRI will take approximately 90-120 minutes. Aim 1 will test the hypothesis that cardiac steatosis induced left ventricular dysfunction is sexually dimorphic, by comparing age-matched men and premenopausal women before and after 48 of fasting. Subjects will complete the MRI/MRS protocol described above before and after the fasting intervention. Aim 2 will test the hypothesis that estrogen is protective against cardiac steatosis-induced dysfunction, by suppressing ovarian sex hormones with a GnRH antagonist and repeating the fasting studies with and without estrogen add-back. 30 female subjects will be treated with GnRH antagonist and repeat the 48 hour fasting intervention and cardiac MRI/MRS protocol. 15 of the subjects will receive estrogen add-back using a transdermal patch, the other 15 subjects will receive a placebo patch. Aim 3 will test whether plasma and myocardial fatty acid composition is sexually dimorphic, by performing comprehensive plasma and myocardial lipidomics assessment.

NCT ID: NCT04669470 Recruiting - Obesity Clinical Trials

Bariatric Endoscopy and NAFLD

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Find out how bariatric endocopy will influence clinical course of non alcoholic fatty liver disease.

NCT ID: NCT04666402 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Integrated Diagnostics for Early Diagnosis of Liver Disease

ID LIVER
Start date: October 21, 2020
Phase:
Study type: Observational

This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.

NCT ID: NCT04653311 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Evaluation of an Endoscopic Sutured Gastroplasty in Patients With NonAlcoholic Steatohepatitis (NASH) and Fibrosis.

ENDONASH
Start date: June 23, 2020
Phase: N/A
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver diseases characterized by liver steatosis which can, in a minority of patients, progress to nonalcoholic steatohepatitis (NASH), fibrosis, and ultimately hepatocellular carcinoma and liver failure. NASH is also recognized as an independent cardiovascular risk factor. Currently, weight loss is the only validated treatment for NASH and also positively affect all the features of metabolic syndrome. Considering the known positive metabolic effects of bariatric surgery, efforts have been exerted to develop minimally endoscopic procedures aiming to induce weight loss. Therefore, we would like to evaluate in patients with NASH disease and fibrosis, the impact of an endoscopic sutured gastroplasty (with Endomina® device) on: - Mainly liver histological endpoints but also, - Surrogate markers of hepatic inflammation and fibrosis and - Surrogate markers of insulin resistance as well as fasting lipid and glycemic profiles.

NCT ID: NCT04647409 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Screening for NAFLD in Flanders

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

In the Belgian adult population more than half, and numbers are still increasing, of the population is overweight or obese. These people are at risk to develop NAFLD. However, we lack epidemiological data in Belgium. Therefore, it is important to do epidemiological studies to investigate NAFLD prevalence and disease severity based on a non-invasive approach and evaluate how patients are to be referred.

NCT ID: NCT04639414 Recruiting - Type 2 Diabetes Clinical Trials

Combined Active Treatment in Type 2 Diabetes With NASH

COMBAT_T2_NASH
Start date: March 26, 2021
Phase: Phase 4
Study type: Interventional

The aim of this multicentre, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is to assess for the first time the effects of either a combined therapy with the antihyperglycemic drugs semaglutide and empagliflozin or empagliflozin monotherapy compared to placebo as potential treatments for non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes.

NCT ID: NCT04625166 Recruiting - Hepatitis B Clinical Trials

Combi-elastography Assessment of Chronic Liver Disease Multi-center Study

Start date: December 1, 2020
Phase:
Study type: Observational

HITACH developed a new combi-elastography imaging technology combines shear wave imaging and strain imaging technology. In the study, not only the F index which is related to the stage of liver fibrosis can be obtained, but also the A index which is related to the stage of hepatitis can be obtained, which can not be obtained by other ultrasound devices.