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Fatty Liver clinical trials

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NCT ID: NCT05073588 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effect of Indo-Mediterranean Diet on Hepatic Steatosis and Fibrosis in NAFLD Children

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent. Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD. European association for study of liver (EASL) guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss. Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation.There are numerous studies in adults showing benefit of Mediterranean diet in comparison with other diet in NAFLD, but data on children is very limited. There are no studies in pediatrics showing the benefit of diet intervention in Indian NAFLD children. The aim of this study will be to compare the effect of Indo-Mediterranean diet and calorie restricted on hepatic steatosis and fibrosis in Overweight Indian children and adolescent with Biopsy proven NAFLD.

NCT ID: NCT05053165 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.

NCT ID: NCT05022693 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis

Start date: August 16, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.

NCT ID: NCT05015491 Completed - Weight Loss Clinical Trials

Effects of Online App Weight Loss Programs on Liver Health in Obese Adults

Start date: August 9, 2021
Phase: N/A
Study type: Interventional

The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.

NCT ID: NCT05010070 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

The University of Michigan Wellness for Liver Health Study

Start date: August 31, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).

NCT ID: NCT05006885 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Start date: September 30, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).

NCT ID: NCT04988633 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.

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

The main purpose of this study is to investigate whether an online lifestyle modification program for people with Metabolic Associated Fatty Liver Disease (MAFLD) through a mobile application produces a significant reduction in liver steatosis and is associated with a higher rate of weight loss compared to standard recommendations currently indicated in Primary Care.

NCT ID: NCT04988230 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD ):a 12-month Follow-up Study

TREATY-FLD
Start date: July 30, 2021
Phase: N/A
Study type: Interventional

Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a 6-month follow-up study of TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 months compared to continuous energy restriction (CER).

NCT ID: NCT04988204 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease

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

Nonalcoholic fatty liver disease (NAFLD) is a rapidly growing epidemic worldwide and is an increasingly important etiology of chronic liver disease and hepatocellular carcinoma. NAFLD affects approximately 90 million people in the United States (US) amounting to an annual cost of $100 billion yearly. It is projected to become the leading cause of liver transplantation in the US by 2030 and is associated with significant morbidity and mortality. NAFLD is a spectrum of liver diseases, ranging from simple steatosis (nonalcoholic fatty liver, NAFL) to hepatic steatosis associated with inflammation (nonalcoholic steatohepatitis, NASH), which can be associated with liver scarring (hepatic fibrosis) and cirrhosis. There are limited therapeutic options that have been shown to effectively reduce or reverse the progression of disease. Lifestyle modification is the backbone of therapy, but difficult to achieve. A modest amount of weight loss of approximately 3% can reduce liver steatosis and a 10% weight loss can reduce the NASH and improve liver fibrosis. The American Association of the Study of Liver Diseases (AASLD) guidelines state that "a combination of a hypocaloric diet (daily reduction by 500-1000 kcal) and moderate intensity exercise is the best likelihood of sustaining weight loss over time." There are several barriers to adopting a healthy lifestyle involving both patient and physician limitations. The aim of this study is to engage patients in a lifestyle intervention program that has already been shown to be successful in achieving weight loss goals and adopting healthier lifestyle patterns. The CDC Diabetes Prevention Program, (DPP) was a large (n=3,234) multicenter study aimed to evaluate the effect of lifestyle intervention or treatment with metformin on the incidence of type 2 diabetes (T2DM). Lifestyle intervention reduced the incidence of T2DM by 58% (95% CI, 48-66%) and metformin reduced the incidence by 31% (95% CI, 17-43%) as compared to placebo. To prevent one case of diabetes over three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin. The CDC DPP program has been adapted and tested in the multiple different community and state-wide programs including the YMCA, WorkWellNYC and NYS DPP. In these real-world models, the life style intervention program has been delivered in a group-based format by DPP lifestyle coaches. These programs have been successful like that of the randomized trial and improvements were sustainable at 6 and 12 month follow up after completion of the program. The program is now available and reimbursable through Medicare (Medicare Diabetes Prevention Program). In this pilot study, the researchers will enroll 20 patients with NAFLD in an adapted DPP program and follow study participants for 1 year. The rationale for the proposed research is to apply the DPP to NAFLD because of the close relationship with Diabetes and determine the real-world outcome of the DPP program on weight loss in patients with NAFLD. If the researchers illustrate that weight loss can be achieved and is sustainable in patients with NAFLD enrolled in lifestyle intervention programs, the researchers can develop innovative approaches to deliver such a program nationwide in a cost-effective and sustainable manner.

NCT ID: NCT04982328 Completed - Covid19 Clinical Trials

COVID-19 and Nonalcoholic Fatty Liver Disease

CovidFAT
Start date: April 1, 2021
Phase:
Study type: Observational

COVID-19 is currently the leading public health problem, associated with a high risk of complications and death in risk groups of patients. Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease with a prevalence of 30% in the Western population and is also recognized as an independent risk factor for the development of severe COVID-19. In the pathogenesis of COVID-19, the key role is played by the hyperreactivity of the immune response, the so-called cytokine storm leading to the development of severe forms of pneumonia, acute respiratory and multiorgan failure. The aim of this study is to investigate the clinical course, outcomes, and profile of inflammatory response in patients with COVID-19 and NAFLD.