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Fatty Liver clinical trials

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NCT ID: NCT04365868 Active, not recruiting - Cirrhosis Clinical Trials

Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

NAVIGATE
Start date: June 22, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

NCT ID: NCT04241575 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages

Start date: May 19, 2020
Phase: N/A
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease worldwide and is a major cause of cirrhosis and liver cancer in Western countries. Because of its close association with obesity and diabetes, most patients are seen by primary care physicians and endocrinologists rather than hepatologists. Previous studies have shown that NAFLD is under-recognized outside specialist settings. As a result, many patients are undiagnosed and not receiving specific treatments. With this background, we aim to test the hypothesis that the use of simple fibrosis scores as part of a diabetes complications screening program followed by electronic reminder messages is more effective than usual care in prompting physicians to correctly identify patients with suspected NAFLD and advanced liver fibrosis for specialist referral or further liver assessment. Our secondary aim is to test the hypothesis that the use of fibrosis scores and electronic reminder messages can increase the number of patients with confirmed diagnosis of advanced liver fibrosis.

NCT ID: NCT04227782 Active, not recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

MRI and Stable Isotope Tracer Studies for Detecting the Progression of Non-Alcoholic Steatohepatitis (NASH)

MRI-Detect
Start date: March 1, 2020
Phase:
Study type: Observational

One-third of the world's population suffers from Non-Alcoholic Fatty Liver Disease (NAFLD), that is a disease with an accumulation of fat in the liver. Some patients with NAFLD will progress in their disease to develop inflammation, scarring of the liver tissue, and cirrhosis that can lead to liver failure. The mechanisms of the disease and its progression are still not fully understood. It is therefore critical to find early markers that can identify the patients that will progress so that they can be treated early. A compound called L-carnitine, synthesised in the body from two amino acids; lysine and methionine, is critical for fat metabolism. Some studies have shown that it is decreased in liver disease patients and that L-carnitine supplementation can protect the liver function. This study aims to increase the understanding of the mechanisms behind NAFLD disease progression through its different stages. This may help diagnostic methods to be developed to predict the patients at risk for developing severe liver disease. Furthermore, fat metabolism and L-carnitine levels will be established in the different disease stages to evaluate whether fat metabolism could be compromised. Magnetic Resonance Imaging (MRI) will be used for imaging of the whole liver and the heart to investigate metabolism and function non-invasively. Whole-body metabolism and how carbohydrates are taken up from diets are converted to fats in the body will be explored using stable isotope labelling. This study will recruit 30 participants with NAFLD; 10 each for low-risk NALFD, biopsy-proven NASH and compensated NASH cirrhosis. Participants will undergo MRI, followed by a stable isotope labelled study, where through blood- and breathe samples, metabolism will be investigated. An additional 10 healthy participants will be assessed using MR techniques to assess whether an injection of L-carnitine can lead to increase of L-carnitine in the liver such that it can be detected by MR. This is to validate a methodology prior to using it in NAFLD participants.

NCT ID: NCT04132440 Active, not recruiting - Clinical trials for Nonalcoholic Fatty Liver Disease

Patient and Physician Perspectives on Non-Alcoholic Fatty Liver Disease

Start date: August 22, 2019
Phase:
Study type: Observational

This trial studies patient and physician perspectives on non-alcoholic fatty liver disease. Using questionnaires and interviews, this trial may help researchers understand physicians' knowledge about the diagnosis, prognosis, treatment and management of non-alcoholic fatty liver disease, as well as gain an in-depth understanding of Hispanic patients' perceptions about the disease and investigate how cultural factors may play a role in its diagnosis, treatment and management.

NCT ID: NCT04067440 Active, not recruiting - Obesity Clinical Trials

Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool

METABIOM
Start date: October 1, 2019
Phase:
Study type: Observational

Characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines.

NCT ID: NCT04063826 Active, not recruiting - Steatohepatitis Clinical Trials

PET-MR Study of Fatty Liver

iDOSH
Start date: April 10, 2018
Phase: N/A
Study type: Interventional

This is a pilot, translational study designed to explore the feasibility of molecular imaging with FBA-A20FMDV2, radiolabelled with fluorine-18 ([18F]-FBA-A20FMDV2), in patients with SH and CASH in hepatic metastatic disease. FBA-A20FMDV2, a synthetic peptide derived from the foot and mouth disease virus (FMDV), has been shown pre-clinically to specifically bind to the epithelial specific integrin αvβ6 which is known to be overexpressed in tumours. In this study, we aim to evaluate the uptake of [18F]-FBA-A20FMDV2 ([18F]-IMAFIB) in patients with SH and CASH in CRC hepatic metastatic disease using PET. Up to ten subjects will undergo [18F]-FBA-A20FMDV-PET scanning. An adaptive study design will enable us to determine the optimal imaging protocol for future studies.

NCT ID: NCT03912272 Active, not recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

12-Month Once-a-week HIIT Improves Body Adiposity and Liver Fat

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Obesity and non-alcoholic fatty liver disease (NAFLD) are two related growing epidemics that are becoming pressing public health concerns. High-intensity interval training (HIIT) is a promising cost-effective and time-efficient exercise modality for managing obesity and NAFLD. However, patients with obesity and NAFLD are generally inactive and unfit, and might feel intimidated by the frequency of the prescribed HIIT (conventionally three times weekly). Previous HIIT studies, mostly over 2-4 month periods, showed that the participants could accomplish this exercise frequency under a controlled laboratory environment, but the long-term adherence and sustainability, especially in a field setting, remains uncertain. The situation is more unclear if we also consider those individuals who refused to participate possibly because of their overwhelming perceptions or low self-efficacy toward HIIT. Thus, logically, HIIT at a lower frequency would be practical and more suitable for patients with obesity and NAFLD, but the minimum exercise frequency required to improve health, especially in the long-term, is unknown. This proposed study aims to examine the effectiveness of long-term low-frequency HIIT for improving body adiposity and liver fat in centrally obese adults. The premise of this proposal is supported by recent findings that HIIT performed once a week could improve cardiorespiratory fitness, blood pressure, cardiac morphology, metabolic capacity, muscle power, and lean mass. This study will provide evidence for the benefits of long-term low-frequency HIIT with a follow-up period to assess its effectiveness, safety, adherence, and sustainability. We expect this intervention will enhance the practical suitability of HIIT in inactive obese adults and will provide evidence for low-frequency HIIT as a new exercise option in the management of obesity and NAFLD.

NCT ID: NCT03900429 Active, not recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

MAESTRO-NASH
Start date: March 28, 2019
Phase: Phase 3
Study type: Interventional

A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

NCT ID: NCT03696797 Active, not recruiting - Diabetes Clinical Trials

Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This is a treatment study to determine if reducing the body's iron stores by blood donation will improve diabetes control and other problems associated with diabetes such as fatty liver disease.

NCT ID: NCT03674528 Active, not recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Technical Validation of MR Biomarkers of Obesity-Associated NAFLD

NAFLD
Start date: May 4, 2018
Phase:
Study type: Observational

The overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. The first phase is an optimization phase. The second phase is designed to complete a rigorous test of conventional and advanced MRE techniques. Complementary anthropometric, laboratory, and MR measures will also be collected to characterize the cohort and identify factors that affect MRE performance