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Fatty Liver clinical trials

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NCT ID: NCT03897218 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health"

ADLH
Start date: May 20, 2019
Phase: N/A
Study type: Interventional

Studies in recent years have demonstrated that the commensal intestinal flora (microbiome) plays a key role in the development of nonalcoholic steatohepatitis (NASH). An unfavourable microbiom can trigger disease development and progression. On the other hand, recent data show that modulation of the microbiom by a diet can prevent the developement of a NASH. Mechanisms of interaction between nutrition, microbiome, intestine and liver are largely unknown. In this research project, the effect of a fibre-rich oat bran on NASH will therefore be investigated. A better understanding of the interaction between diet, microbiome, intestine and liver could form the basis for new preventive therapies of NASH.

NCT ID: NCT03884075 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)

Start date: July 24, 2019
Phase: Phase 2
Study type: Interventional

Background: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help. Objective: To find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide. Eligibility: People with NAFLD and healthy volunteers ages 18 and older Design: Participants will be screened with: Medical history Physical exam Blood tests Imaging: A machine will take pictures of the participant s body. Within 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes: Blood, urine, heart, and imaging tests For NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue. Participants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times. The baseline visit concludes participation for healthy volunteers but NAFLD participants will contine. About 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection. Participants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests. Participants will inject semaglutide once a week at home. At week 30, participants will stay in the clinic again and repeat the tests. Participants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests. ...

NCT ID: NCT03883607 Terminated - Clinical trials for Non Alcoholic Steatohepatitis

Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)

Start date: June 25, 2019
Phase: Phase 2
Study type: Interventional

The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children and adolescent population (8 to 17 years of age) with non alcoholic steatohepatitis (NASH).

NCT ID: NCT03875625 Recruiting - Diabetes Mellitus Clinical Trials

Change of Adipose Tissues and Triglyceride After Bariatric Surgery or Life-style Intervention

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

The study is aimed - To quantify the change of adipose tissues, triglyceride in liver and pancreas and cholesterol after lifestyle intervention or bariatric surgery. - To test the hypothesis that Brown fat is an independent biomarker for the development of Non Alcoholic Fat Liver Disease (NAFLD) - To study the association among Brown fat, NAFLD and obesity.

NCT ID: NCT03868566 Terminated - Clinical trials for NASH - Nonalcoholic Steatohepatitis

An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD

Start date: August 4, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612. The secondary objectives will be to compare the changes in other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates.

NCT ID: NCT03867487 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease

SLIDE
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.

NCT ID: NCT03866421 Terminated - Clinical trials for Chronic Kidney Diseases

NAFLD Among Patients With Chronic Kidney Disease and the Effect of Kidney Transplantation

Start date: May 29, 2019
Phase:
Study type: Observational

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries affecting approximately 30 % of the general adult population. It represents an important pathogenic factor in the development of type 2-diabetes and is associated with a high risk of cardiovascular disease. Previous studies of patients with chronic kidney disease (CKD) have demonstrated an increased risk for NAFLD and the presence of both CKD and NAFLD is likely to increase the risk for cardiovascular disease. The present protocol describes a study of the prevalence and etiology of NAFLD among patients scheduled for kidney transplantation and the possible effect of kidney transplantation on NAFLD. The project is a prospective cohort study. The effect of kidney transplantation in patients with prediabetes or normal glucose tolerance compared to healthy controls will be examined regarding development and progression of fat accumulation in the liver. Fat accumulation in the liver will be determined by magnetic resonance (MR) spectroscopy and the prevalence of NAFLD in the two groups will be investigated. A continuous glucose monitoring (CGM) for four days, Dual Energy X-ray Absorptiometry (DEXA) scanning, fibro scanning of the liver, bile acid analysis, metabolomic and lipidomic analysis will also be performed. An oral glucose tolerance test (OGTT) and an intra venous glucose infusion (IIGI) will be performed.

NCT ID: NCT03864835 Withdrawn - Clinical trials for Non-Alcoholic Fatty Liver Disease

NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal

NASH-FITTER
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

This research is being done to find out if aerobic exercise is beneficial in reversing scarring. Physical activity has been shown to increase fitness in healthy individuals as well as in those with NASH. This research will allow for better understanding the effects of physical activity on fitness and endothelial function in patients with NASH with the goal of reversing scarring. Approximately 12 people will take part in this research study at Penn State (PSU) Milton S. Hershey Medical Center (HMC), Penn State Physical Medicine & Research (PM&R) Laboratories housed at the Hershey Center for Applied Research (HCAR) and the Penn State University Fitness Center (UFC).

NCT ID: NCT03864783 Completed - Insulin Resistance Clinical Trials

The Effect of Curcumin on Liver Fat Content in Obese Subjects

Start date: March 5, 2019
Phase: N/A
Study type: Interventional

The majority of obese have non-alcoholic fatty liver disease (NALFD). Currently, no pharmacological agents are licenced for the prevention or treatment of NAFLD, and weight loss, notoriously difficult to obtain (and specially to maintain), remains the only treatment option. Interestingly, curcumin, a phenolic compound extracted from the turmeric root, has from in vitro and animal studies shown promising effects in preventing and treating NAFLD, and the sparse available human data point in the same direction; but solid human data are missing. This study will delineate the effects of curcumin when treating NAFLD in humans. The primary aim of this study is to investigate the effect of 6 weeks of curcumin on liver fat content (assessed by magnetic resonance spectroscopy (MRS)) in obese subject with NAFLD. Additionally, a range of secondary endpoints have been chosen in order to delineate the role of NAFLD in the newly discovered liver-alpha cell axis governing circulating levels of the glucose-mobilising pancreatic alpha cell hormone glucagon and, thus, to elucidate the link between liver fat content and the risk of developing reduced glucose tolerance and type 2 diabetes (T2D). Also, the anti-inflammatory effect of curcumin will be elucidated, as inflammatory markers will be measured before and after intervention. Furthermore, the effect of curcumin will be measured by measuring the following parameters before and after intervention: Transient elastography, anthropometric measurements, body weight, appetite, food-consumption, calory balance, resting energy expenditure, gut microbiota, bioimpedance measures, visceral- and subcutaneous fat, glucose tolerance, lipids, blood pressure, pulse, liver parameters (blood-tests) and adipokines. During the oral glucose tolerance test before and after intervention, incretin hormones, glucagon, amino acids, insulin, c-peptide and urea will be measured.

NCT ID: NCT03864744 Enrolling by invitation - Diabetes Mellitus Clinical Trials

Hepatic Histology and Metabolism Following Total Pancreatectomy and Pancreaticoduodenectomy

Start date: January 30, 2019
Phase:
Study type: Observational

The objective of the study is to investigate the development of NAFLD following total pancreatectomy and pancreaticoduodenectomy and to explore the histological and metabolic changes following the procedures.