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NAFLD 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: 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: 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: NCT04263376 Completed - Obesity Clinical Trials

Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD

Start date: April 24, 2019
Phase:
Study type: Observational

This study is designed as a prospective pilot study for longitudinal assessment of fecal microbiome related to medical and surgical weight loss. The investigators follow the standard of care for perioperative and intraoperative management of study participants. The only addition to the standard of care protocol will be collection of fecal samples at 3 time points. This will enable investigators to compare changes in and effects by microbiota after low-calorie diet versus after bariatric surgery .

NCT ID: NCT04248335 Recruiting - NAFLD Clinical Trials

Effect of Obesity on Proton Pump Inhibitors

LiverLabPPI
Start date: July 3, 2018
Phase: Phase 4
Study type: Interventional

This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.

NCT ID: NCT04235855 Completed - NAFLD Clinical Trials

EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?

Start date: October 31, 2019
Phase: N/A
Study type: Interventional

Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.

NCT ID: NCT04232293 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus

L-FibroT2DM
Start date: June 25, 2021
Phase: N/A
Study type: Interventional

Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity. This disease has been linked with an increased morbidity and mortality, in particular cardiovascular disease and hepatic complications (cirrhosis and hepatocellular carcinoma). NAFLD is covered different liver damage in ascending order: steatosis, Non-Alcoholic SteatoHepatitis (NASH), fibrosis, and finally cirrhosis. Mostly, fibrosis has a determining role in the patient's status health. The fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes. The purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes. To be sure of the status of the disease, the gold standard procedure remains liver biopsy. However, it's an invasive procedure and it's a challenge to perform this kind of medical procedure to every patient with NAFLD. Some alternative procedure exists, called FibroScan that gives some indication of liver fibrosis status. Unfortunately, every diabetologist hasn't this equipment in his medical office. The investigators propose to evaluate two non-invasive biological fibrosis tests, called eLIFT and FibroMeter. The results of these two diagnostic tests will be compared to FibroScan and to liver biopsy results.

NCT ID: NCT04220450 Not yet recruiting - Heart Failure Clinical Trials

T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease

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

On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.

NCT ID: NCT04215926 Recruiting - NAFLD Clinical Trials

NAFLD in HIV-infected Patients

NAFLDIH
Start date: December 5, 2019
Phase:
Study type: Observational

The prevalence of NAFLD (nonalcoholic fatty liver disease) in HIV-infected patients is higher than that in general population, but the causes of morbidity and pathogenesis have not been fully explored. The investigators are planning to consecutively enroll 400 cases HIV-positive outpatients, and to detect NAFLD by ultrasound. The fecal and blood samples were also collected to explore the mechanism of NAFLD. The investigators aimed to determine the prevalence and risk factors of NAFLD in HIV infected patients.

NCT ID: NCT04193982 Recruiting - NAFLD Clinical Trials

An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)

Start date: January 31, 2021
Phase: Phase 3
Study type: Interventional

Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.