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Fatty Liver clinical trials

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NCT ID: NCT03082703 Completed - NAFLD and NASH Clinical Trials

Impact of Text Messaging in the Management of Non-alcoholic Fatty Liver Disease

Start date: March 24, 2016
Phase: N/A
Study type: Interventional

This randomized study aims at examining the impact of text messaging in the management of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), a disease frequently associated with obesity and varying components of metabolic syndrome including diabetes mellitus, hypertension, and dyslipidemia. With rising incidence of obesity in the US, NAFLD and NASH are rapidly increasing with currently the second etiology for liver transplantation in the US. The objectives of this protocol are to a) prospectively enroll patients with NAFLD and NASH; b) randomize them to receiving text messaging to help manage obesity and other components od metabolic syndrome in addition to standard clinical care or receiving only standard clinical care; and c) follow up these patients at the end of 3 months period for weight loss, blood pressure control, HBA1c, and liver enzymes. The immediate aim of this protocol is to develop the pilot data on the usefulness of text messaging in the management of NAFLD and NASH. The long-term goals of this research are to establish text messaging as a beneficial intervention in the management of weight loss and control of risk factors of NAFLD and improve outcomes of these patients with NAFLD and NASH.

NCT ID: NCT03068078 Completed - Atherosclerosis Clinical Trials

A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes

ReDuCtion
Start date: November 2016
Phase: N/A
Study type: Interventional

Further studies are needed to establish the optimal diet for treating T2D. The investigators wishes to investigate whether a low carbohydrate diet, high in monounsaturated fats (LCD) will affect cardiovascular function, metabolism and the liver. 135 participants with T2D, will be following either a LCD, or a regular diabetes diet (RDD) for 6 months. Measurements and investigations will be performed at baseline and after 6 months.

NCT ID: NCT03068065 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Antidiabetic Effects on Intrahepatic Fat

Start date: May 2014
Phase: Phase 4
Study type: Interventional

This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.

NCT ID: NCT03067428 Completed - Clinical trials for Endothelial Dysfunction

Effects of Fructose Restriction on Liver Steatosis

FRUITLESS
Start date: January 31, 2017
Phase: N/A
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem as it can lead to end stage liver failure and cardiovascular complications. Diet play an important role in the development of NAFLD. Many studies have addressed the effects of added fructose on NAFLD. To date, little attention has been paid to the effects of a diet devoid of fructose. Therefore, the investigators aim to study the effects of fructose restriction on hepatic fat accumulation and vascular function using a double-blind randomized placebo-controlled design.

NCT ID: NCT03061721 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

EVIDENCES IV
Start date: April 6, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group.

NCT ID: NCT03060694 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements

Start date: September 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in non-diabetic patients.

NCT ID: NCT03060538 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease

Start date: March 5, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending−dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.

NCT ID: NCT03042767 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease (NAFLD)

Anti-LPS Antibody Treatment for Pediatric NAFLD

Start date: February 1, 2017
Phase: Phase 2
Study type: Interventional

The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT). Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in treatment compared to placebo.

NCT ID: NCT03041129 Completed - Obesity Clinical Trials

Post-Prandial Liver Glucose Metabolism in PCOS

PLUM
Start date: April 14, 2017
Phase:
Study type: Observational

The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.

NCT ID: NCT03008070 Completed - Clinical trials for Non-Alcoholic Steatohepatitis (NASH)

Phase 2b Study in NASH to Assess IVA337

NATIVE
Start date: February 7, 2017
Phase: Phase 2
Study type: Interventional

Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic. The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.