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Fatty Liver clinical trials

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NCT ID: NCT01792115 Completed - Fatty Liver Clinical Trials

Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E

Start date: May 1, 2013
Phase: Phase 2
Study type: Interventional

Background: - Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not. - Lifestyle changes such as diet, exercise, and weight loss can decrease the liver damage in NAFLD. Some studies show that vitamin E can also help treat NAFLD. The dose of vitamin E used in these studies is almost 40 times the recommended amount of vitamin E intake from food. It is unclear whether a lower dose could achieve the same effect. Researchers also want to study how vitamin E works at different doses to treat NAFLD. Objectives: - To find out the most effective dose of vitamin E to treat NAFLD. - To gain a better understanding of how NAFLD and NASH develop, and predict who will respond to treatment. Eligibility: - Individuals at least 18 years of age with suggestion of non-alcoholic fatty liver disease. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - For the first 12 weeks of the study, participants will meet with a nutritionist. They will have personalized diet and exercise plans. Treatment will be monitored with diaries and questionnaires to fill out at home. Participants will also wear a pedometer to measure physical activity. - After the 12-week period, participants will have a full physical examination with the following tests: - Blood tests - Glucose tolerance tests - Imaging studies (DEXA scan and magnetic resonance imaging) - Liver and fatty tissue biopsy - Two weeks after the tests, participants will start vitamin E treatment. They will take up to two pills a day, taken with fat-containing foods. - 4 weeks after starting treatment they will have a repeat full evaluation with imaging tests, blood work, and liver and fat biopsies. - Participants who are taking vitamin E will take it for up to 120 weeks. They will have monitoring visits every 8 to 12 weeks. At the end of 120 weeks, they will have another full evaluation, with imaging tests, blood work, and liver and fat biopsies.

NCT ID: NCT01791959 Completed - Clinical trials for Non Alcoholic Steatohepatitis

The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Start date: March 2012
Phase: Phase 2/Phase 3
Study type: Interventional

To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.

NCT ID: NCT01791452 Not yet recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

Novel Association of Cholesterol Ester Storage Disease Due to Lysosomal Acid Lipase Deficiency and Non-Alcoholic Fatty Liver Disease: A Prospective Clinical Study

Start date: n/a
Phase: N/A
Study type: Observational

Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to 90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients are of especial practical and theoretical importance. Cholesterol Ester Storage Disease (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in tissues and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with varying degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is poorly understood, the investigators propose to evaluating the association between NAFLD and LAL deficiency in a prospective study in our population.

NCT ID: NCT01790984 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease (NAFLD)

How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype (ALP)?

CHOT
Start date: April 2009
Phase: N/A
Study type: Interventional

The hypothesis of this study is that a diet high in sugars will increase abnormalities in blood lipids which are associated with increased cardiovascular disease risk, relative to a diet which is low in sugar. We predict that this potentially adverse effect of dietary sugars on blood lipids will be more pronounced in people with a raised level of stored fat inside their liver, as compared to people with a low level of stored fat.

NCT ID: NCT01787591 Active, not recruiting - Metabolic Syndrome Clinical Trials

Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome

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

This study is conducted to investigate if vitamin E status in healthy individuals and individuals with metabolic syndrome can be improved by dairy fat. The investigators hypothesize that full-fat dairy will substantially increase the bioavailability of alpha-tocopherol, a form of vitamin E. The results of this study will contribute to the application of dairy fat as a simple and effective strategy for improving vitamin E status, which is partly due to poor vitamin E intake. By completing this study, the investigators anticipate developing new dietary recommendations to achieve adequate vitamin E status through the regular consumption of dairy fat paired with foods containing vitamin E.

NCT ID: NCT01766960 Completed - Fatty Liver Clinical Trials

Altered Drug Disposition and Biomarkers for Diagnosis of Chronic Inflammatory Liver Disease

Start date: November 2012
Phase: Phase 1
Study type: Interventional

One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people have this disease, the change in how the liver handles drugs and compounds in the body has not been studied. The purpose of this study is to investigate how advanced NAFLD changes the ability of the liver to handle both endogenous and exogenous compounds.

NCT ID: NCT01766713 Completed - Clinical trials for Non Alcoholic Steatohepatitis

Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis

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

The purpose of the study is to see if the drug ezetimibe is a potential treatment for Nonalcoholic Steatohepatitis(NASH).

NCT ID: NCT01761370 Completed - Clinical trials for Non Alcoholic Steatohepatitis

Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Start date: November 2005
Phase: N/A
Study type: Interventional

The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).

NCT ID: NCT01761318 Completed - Metabolic Syndrome Clinical Trials

Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients

MAGNA VICTORIA
Start date: November 2013
Phase: Phase 4
Study type: Interventional

The most important cause of mortality amongst DM2 patients is cardiovascular disease. An early finding of cardiovascular disease in DM2 and obesity is diastolic dysfunction. Diastolic dysfunction is an independent predictor of mortality and has been shown to improve in patients on a low calorie diet. The improvement of diastolic function was associated with a reduction in triglyceride accumulation in the heart and liver. A relatively new widely prescribed therapeutic agent for DM2 patients is Liraglutide (Victoza®). Liraglutide is a Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and body weight. Next to the induction of weight loss, which is potentially beneficial for cardiac function, GLP-1 therapy might have a direct advantageous effect on the cardiovascular system. However, the effect of Liraglutide on cardiovascular function has not been investigated yet. The investigators hypothesize that treatment of DM2 patients with Liraglutide is associated with improvement of cardiovascular function and a reduction of triglyceride accumulation in end-organs.

NCT ID: NCT01759628 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Helicobacter Pylori Eradication in Subjects With Non-alcoholic Fatty Liver Disease

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

The aim of study was to evaluate the effect of helicobacter pylori eradication on liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in subjects with non-alcoholic fatty liver disease.