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Fatty Liver clinical trials

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NCT ID: NCT03585413 Completed - Obesity Clinical Trials

Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery

FMG-01
Start date: August 31, 2018
Phase: Phase 3
Study type: Interventional

Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese, nonalcoholic fatty liver disease (NAFLD) patients after Mini-Gastric Bypass (MGB) surgery.

NCT ID: NCT03583437 Completed - Clinical trials for NAFLD - Nonalcoholic Fatty Liver Disease

Hepatic and Cardiac Metabolic Flexibility in Obese With NAFLD.

Start date: September 3, 2018
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac involvement and the progression from NAFLD to NASH are poorly understood but must include altered cardiac and intrahepatic lipid handling. In collaboration with renowned research groups from Oxford, Mayo Clinic and Copenhagen investigators plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with NAFLD and NASH and the relationship with heart function. In addition, the investigators will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. Investigators will address these questions using innovative tracer techniques (11Cpalmitate, 11C acetate, 18FDG glucose PET tracers and TG tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as NMR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. Effects of acute exercise will be assessed. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism and to assess the effect of exercise on both hepatic, cardiac and adipose and skeletal muscle lipid and substrate utilisation.

NCT ID: NCT03576755 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Spironolactone Therapy In Young Women With NASH

Start date: January 9, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urgent need to understand risk factors for NASH and its progression in women, and sex hormones may provide a missing link. The investigator's preliminary data support a detrimental role of androgens, or "male sex hormones" on fatty liver in women but no studies have evaluated whether androgens are associated with liver inflammation and/or scarring from fatty liver (aka NASH). To better understand the mechanism by which androgens might promote NASH and/or metabolic co-factors that contribute to NASH, the investigators are conducting a pilot clinical trial to primarily assess the feasibility of using an androgen blocking medication, spironolactone, in women with NASH. Spironolactone was selected because it is has been commonly prescribed for decades with good safety profile and tolerability to treat symptoms of high androgens, like acne and hirsutism in young women. Though primarily a feasibility-focused study, the investigators also aim to explore the pathways by which blocking testosterone receptors might alter the biologic processes that promote NASH and its associated metabolic co-morbidities in women.

NCT ID: NCT03572465 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis

QUS in NASH
Start date: October 23, 2019
Phase:
Study type: Observational

Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH). If left untreated, NASH can evolve to cirrhosis, the late stage of fibrosis. Once cirrhosis is established, patients are at increased risk of developing gastrointestinal bleeding, liver cancer and liver failure that may require transplantation. A liver biopsy is currently needed to diagnose the severity of fatty liver disease but this is usually not indicated in asymptomatic patients. This procedure requires the insertion of a needle inside the liver to remove a small piece of tissue for examination under microscope. Liver biopsy is an invasive procedure with a small risk of major complications such as bleeding in 0.5% of cases. It is also affected by sub-optimal sampling leading to diagnostic errors Ultrasound is optimum for screening patients with or without symptoms because it is a safe and widely available technology to scan the whole liver. Members of our team have developed Advanced ultrasound techniques that provide unique information not possible with state-of-the-art techniques. Unlike liver biopsy, these techniques would be applicable even in asymptomatic patients because it is non-invasive. This research proposal proposes a novel approach for diagnosis of NASH and will be the first study to measure individual components of NASH (fat, inflammation and fibrosis) with quantitative ultrasound (QUS) scores. This study is timely because NASH is the second leading cause of liver transplantation in North America and is predicted to become the leading indication in the near future.

NCT ID: NCT03566173 Completed - Acute Pancreatitis Clinical Trials

Association Between Nonalcoholic Fatty Liver Disease and Acute Pancreatitis

Start date: March 10, 2018
Phase:
Study type: Observational [Patient Registry]

The early evaluation of AP severity are vital. Previous studies have shown non-alcoholic fatty liver disease (NAFLD) is associated with severity of acute pancreatitis (AP). This study is aimed to investigate the relationship between NAFLD and AP severity.

NCT ID: NCT03551522 Terminated - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

Start date: April 30, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH) OLE phase was not analyzed due to the early termination of the study

NCT ID: NCT03542578 Recruiting - Liver Steatoses Clinical Trials

Diagnosis of Fatty Liver With Outpatient Ultrasound

Start date: September 12, 2018
Phase:
Study type: Observational

This study will evaluate whether ultrasound performed during outpatient visit is effective in early diagnosis of fatty liver.

NCT ID: NCT03538236 Withdrawn - Obesity Clinical Trials

Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess efficacy of intragastric balloon for weight loss in obese patients who also concurrently have NASH.

NCT ID: NCT03536650 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Effect of DMR in the Treatment of NASH

DMR_NASH_001
Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is a frequent disease affecting up to 25% of the USA population, 2-44% in Europe and up to 42,6-69,5% in patients with type 2 diabetes. It is a disease that could progress from simple steatosis to non-alcoholic steatohepatitis (NASH), hepatic cirrhosis and hepatocarcinoma. NASH is part of continuum of metabolic syndrome and constitutes a serious public health concern manifesting by premature cardiovascular disease, end stage diabetes complication and will likely become the first cause of end stage liver disease. Insuline resistance is the hallmark of NASH. Some recent studies both in animals and humans have demonstrated abnormal hypertrophy of the duodenal mucosa, changes in enteroendocrine cell density and number, endocrine hyperplasia, and alterations in gut hormone signaling highlighting the role of the upper intestine gut in glucose homeostasis and thus insulin sensitizing. Given these physiological and pathophysiological features, abrasion of duodenal mucosa was assessed both in animals and humans. The investigators reported an improvement in both glucose homeostasis and transaminases levels suggesting possibly an improvement of NASH. Until now, lifestyle medication is the only recognized efficient treatment for fatty liver disease. Unfortunately, only a minority of patients achieve a significant weight loss and lifestyle modifications. The investigators aim to study the duodenal mucosal resurfacing procedure in patients with NASH biopsy proven in a proof of concept study allowing to assess this technique as a potential treatment to NASH.

NCT ID: NCT03535142 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Prognostic Significance of Fatty Liver Disease in Bariatric Patients

PROMETHEUS
Start date: August 15, 2018
Phase: N/A
Study type: Interventional

Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.