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Fatty Liver clinical trials

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NCT ID: NCT04308980 Recruiting - NAFLD Clinical Trials

Safety and Tolerability of Novel Medical Nutrition Products for NAFLD Treatment

052920190055
Start date: March 20, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

To the moment, only limited data are present on the efficacy of changes in diet composition of patients with non-alcoholic fatty liver disease (NAFLD). The national database search in the federal registry of specialized products revealed no registered products for medical nutrition for patients with NAFLD. We developed the composition of specialized food products, produced their experimental batches, and performed laboratory studies of their safety, including tests on toxicology and microbiology (which revealed no concerns). Organoleptic studies of the products showed acceptable results. The aim of the present study is to assess safety and tolerability of newly developed specialized products for medical nutrition of patients with non-alcoholic fatty liver diseases in a prospective randomized placebo-controlled trial.

NCT ID: NCT04306939 Suspended - Clinical trials for Rheumatoid Arthritis

Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study

GREAT1
Start date: November 1, 2014
Phase:
Study type: Observational

This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.

NCT ID: NCT04302051 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Assessment of Fatty Liver With Thermo-acoustic Device

Start date: November 2, 2023
Phase:
Study type: Observational

The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.

NCT ID: NCT04298736 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Bariatric Surgery vs. Lifestyle Modification for NASH

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

Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.

NCT ID: NCT04292977 Completed - NAFLD Clinical Trials

Splanchnic and Systemic VLDL-TG and FFA Balance

Start date: December 1, 2018
Phase:
Study type: Observational

To determine differences between NAFLD and NASH subjects with respect to hepatic FA metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects with NAFLD and 8 with NASH (biopsy proven) will be studied in the overnight fasted state. VLDL-TG stable isotope will be used in combination with hepatic vein catherization to directly measure splanchnic VLDL-TG uptake and secretion. FFA (palmitate) tracers as well as adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate turnover and flexibility as well as tissue specific substrate handling during fasting and hyperinsulinemic conditions.

NCT ID: NCT04284371 Terminated - Obesity, Childhood Clinical Trials

The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients

Start date: February 10, 2016
Phase:
Study type: Observational

The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI

NCT ID: NCT04283942 Completed - Type 2 Diabetes Clinical Trials

Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism

Start date: July 30, 2020
Phase: N/A
Study type: Interventional

This study is designed to observe the effect of 5:2 intermittent calorie restriction (fasting 2 days each week) on liver fat content in MASLD patients with abnormal blood glucose.

NCT ID: NCT04282447 Recruiting - Clinical trials for Nonalcoholic Fatty Liver Disease

Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg

NASH-SPE
Start date: August 14, 2020
Phase:
Study type: Observational

The aim of the present study is to assess, by using a simple algorithm combining FIB-4 and Fibroscan, the prevalence of NASH with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. The prevalence of NASH will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at Hôpitaux Universitaires de Strasbourg.

NCT ID: NCT04282005 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease (NAFLD)

Metabolic Surgery for Steato-Hepatitis

MeSH
Start date: February 13, 2020
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is associated with obesity and type 2 diabetes mellitus (T2DM) and is characterised by excess liver fat on imaging or histology. NAFLD affects up to 25% of the Western population. It's more aggressive form is non-alcoholic steatohepatitis (NASH) characterised by cell injury, inflammation and fibrosis, and is associated with increased mortality from liver and cardiovascular disease. Currently, there is no specific treatment for NASH. Diet and exercise-induced weight loss remain the only recommended options. However, maintaining weight loss in the long term is difficult. There is therefore a significant unmet need for effective therapy in patients with NASH that can address the underlying mechanisms of disease. Although preliminary observational evidence suggests that bariatric/metabolic surgery, especially RYGB can improve NASH, no controlled trials to date has confirmed the efficacy of surgery compared to standard weight loss programs. Also, while animal and clinical studies have shown that bariatric surgery exerts weight-independent effects on glucose metabolism, it is yet unknown if the observed effects of bariatric/metabolic surgery on NASH are due to weight loss alone or result from additional, weight-independent mechanisms, like in the case of T2DM. If the effect of surgery on inflammation, liver fibrosis and other mechanisms of cardiometabolic risk were found to be independent on weight reduction, there would be profound and far-reaching implications for both the treatment and the understanding of NASH, cardiovascular disease and obesity-related cancers. This project will investigate the hypothesis that, similarly to surgical control of diabetes, bariatric/metabolic surgery can also exert weight-independent effects on mechanisms of disease in NAFLD/NASH (i.e. influence on lowgrade inflammation and markers of fibrosis)

NCT ID: NCT04281303 Not yet recruiting - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Endoscopic Bariatric Therapy in NASH Cirrhosis

ETHIC
Start date: April 1, 2020
Phase:
Study type: Observational

Non-alcoholic steatohepatitis (NASH) is a growing public health problem that affects more than 5% of the population and can lead to cirrhosis and hepatocellular carcinoma. These patients are at greater risk of cardiovascular and hepatic death, and higher rates of neoplasms, both gastrointestinal and extra-intestinal. The standard treatment is weight loss with diet and physical exercise, which has shown a histological and analytical improvement in patients who achieve a 5-10% reduction in body weight. However, less than 25% of subjects achieve this goal. Restrictive surgical treatments and gastric bypass have achieved, in obese patients, an improvement in metabolic syndrome, insulin resistance and liver histology, but in patients with liver cirrhosis the morbidity-mortality of this surgery is high. Currently, endoscopic techniques are being developed, which are less invasive and have fewer complications, and which also achieve gastric restriction with similar characteristics to those obtained by the surgical method. Among them is the tubulization or vertical gastroplasty with the OverStitch system (Apollo Endosurgery, Austin, TX, USA). However, this method has not been evaluated in patients with obesity and/or metabolic syndrome and NASH cirrhosis. For this reason, the main objective of the investigators study is to evaluate the safety and efficacy of endoscopic gastroplasty in improving metabolic factors and liver histology in patients with obesity with or without metabolic syndrome and NASH-compensated cirrhosis.