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Fatty Liver clinical trials

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NCT ID: NCT01950884 Enrolling by invitation - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

Start date: October 2013
Phase: Phase 4
Study type: Interventional

- NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver disease in Western countries (hepatic manifestation of insulin resistance); - NAFLD represents a cardiovascular risk factor; - Lifestyle modification(weight loss)is the effective medical treatment recommended for NASH (Non-alcoholic Steatohepatitis); - Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

NCT ID: NCT01940263 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Start date: June 2013
Phase: Phase 0
Study type: Interventional

Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.

NCT ID: NCT01934777 Completed - Obesity Clinical Trials

Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

NCT ID: NCT01930123 Terminated - Clinical trials for Nonalcoholic Fatty Liver Disease (NAFLD)

Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease

Start date: October 2013
Phase: Phase 2
Study type: Interventional

This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for imaging in liver in both a cross-sectional and a longitudinal dietary intervention study of patients with Nonalcoholic Fatty Liver Disease (NAFLD), 3) create a liver tissue bank with correlative imaging data, 4) develop reliable non-invasive MR markers to distinguish simple steatosis from Nonalcoholic Steatohepatitis (NASH), and 5) define the dynamic changes in metabolism, energy homeostasis, and MR biomarkers as they relate to fructose-related liver injury.

NCT ID: NCT01919294 Completed - Hypogonadism Clinical Trials

Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)

TEREPINS
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months 1. improve severity of steatosis on liver biopsy (Primary Question)? 2. improve severity of associated steatohepatitis on liver biopsy? 3. reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)? The work proposed here is an open pilot study of 10 patients, the main aim of which is to assess the effect size of TRT in regard to these end points (regarding which there are no published data), thereby allowing power calculations for a more definitive phase II trial. Other aims would be assessing recruitment and consent rates, which would also inform the design of the larger study.

NCT ID: NCT01900015 Completed - HIV Infection Clinical Trials

Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

STERAL
Start date: February 3, 2014
Phase: Phase 4
Study type: Interventional

Primary Objective: To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient. Secondary Trial Objective: 1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs. 2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching. Design: Open-label, randomized clinical trial to evaluate safety (phase IV) Condition: HIV and HCV coinfection. Intervention: Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.

NCT ID: NCT01899859 Completed - Clinical trials for Non-Alcoholic Steatohepatitis (NASH)

Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis

Start date: July 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.

NCT ID: NCT01894438 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Mediterranean Lifestyle Intervention in Patients With Non-alcoholic Fatty Liver Disease

Start date: April 2013
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis and non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver (liver fat >5-10% of liver weight), not due to excess alcohol consumption or other causes of steatosis. At present, no medication or surgical procedure has been approved for treating NAFLD and lifestyle modifications remain the cornerstone therapy targeting both at weight reduction for overweight subjects and at prevention of overweight for the normal weight individuals. Given that a Mediterranean dietary pattern has a beneficial effect both on the prevention and the resolution of the metabolic syndrome, the main aim of the present study is to implement and evaluate the potential benefits of an intervention based on the Mediterranean lifestyle in a sample of patients with NAFLD.

NCT ID: NCT01876108 Completed - Insulin Resistance Clinical Trials

The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

NCT ID: NCT01875978 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Effect of Phytosterols on Nonalcoholic Fatty Liver Disease

Start date: October 2012
Phase: N/A
Study type: Interventional

Phytosterols are plant sterols . Phytosterols have anti-inflammation effect. Investigators have a hypothesis: phytosterols reduce oxidative stress , enhance Insulin-like growth factor-1(IGF-1) and endothelial progenitor cells(EPCs). Therefore, phytosterols has novel role in cardiovascular protection.