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Fatty Liver clinical trials

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NCT ID: NCT00389376 Completed - Hepatitis C Clinical Trials

Phase I Trial of Silymarin for Chronic Liver Diseases

SyNCH
Start date: November 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.

NCT ID: NCT00323414 Completed - Fatty Liver Clinical Trials

Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver

Start date: April 2006
Phase: Phase 2
Study type: Interventional

Non-alcoholic steatohepatitis (NASH), the most severe form of liver injury in the spectrum of non-alcoholic fatty liver disease (NAFLD), has emerged as the major cause of chronic liver disease in developed countries. Among adults in the United States, the prevalence is between 5.7% and 17%. These rates are expected to increase concurrent with the epidemics of obesity and type 2 diabetes mellitus, which are the major risk factors for NAFLD and NASH. In addition to its high prevalence, NASH is also a progressive fibrotic disease that advances to cirrhosis and liver related death in 20% and 12% of patients, respectively. Among NASH patients with cirrhosis, 40% have liver related death. Diabetics are particularly prone to experience these poor outcomes. No therapy has been proven effective for patients with NASH. The purpose of this study is to find out whether treatment with polyunsaturated fatty acids (eicosapentaenoic acid [EPA] combined with docosahexaenoic acid [DHA] called Opti-EPA) improves NASH compared to treatment with placebo pills. The placebo pills will contain corn oil and will be contained in a capsule, but have no medical effect on the body. The investigators will determine improvement in NASH from microscopic changes in the subject's liver tissue during 48 weeks of treatment. This means that the subject will need to have a liver biopsy before and after the treatment. Omega-3 fatty acids are a form of polyunsaturated fats, one of the four basic types of fat that the body gets from food. (Cholesterol, saturated fat, and monounsaturated fat are the others.) One's body does not make this type of fat; it comes from food sources. These fats are found in foods like cold water fish (tuna, salmon, and mackerel), and vegetable products like flaxseed oil and walnuts. Research shows that polyunsaturated fats are good for people. Studies have shown that it is good for heart health by playing a role in keeping blood cholesterol levels low, keeping irregular heart rhythms stable, and reducing blood pressure. The drug being studied, Opti-EPA, is a nutritional supplement. They do not have to be reviewed by the Food and Drug Administration (FDA) like medicines do. Opti-EPA is considered experimental in this study. This means that the United States Food and Drug Administration (FDA) has not approved it for use in people with nonalcoholic fatty liver disease.

NCT ID: NCT00274183 Completed - Fatty Liver Clinical Trials

Nonalcoholic Fatty Liver Disease in Taiwanese Children

Start date: January 2006
Phase:
Study type: Observational

Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan. However, the prevalence and clinical characteristics have not been studied well. The purpose of this study is to resolve the aforementioned problem.

NCT ID: NCT00267670 Completed - Liver Diseases Clinical Trials

Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH

Start date: March 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.

NCT ID: NCT00266019 Completed - Fatty Liver Clinical Trials

Weight Management in Nonalcoholic Steatohepatitis

Start date: January 2005
Phase: Phase 2
Study type: Interventional

Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The cause of NASH is not completely understood and currently there is no effective treatment for this disease. An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management. However, there are very limited data on the efficacy of weight reduction as a treatment for NASH. Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve fatty liver disease. The objective of this project is to conduct a randomized controlled trial of weight reduction in the management of NASH using a combination of diet, exercise, and behavior modification.

NCT ID: NCT00262964 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Obesity and Nonalcoholic Fatty Liver Disease

Start date: October 2004
Phase: N/A
Study type: Interventional

The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following hypotheses will be tested: 1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat tissue and increased free fatty acid availability, 2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar) production by the liver and altered liver protein synthesis, 3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic inflammation, necrosis and fibrosis, and 4. marked weight loss improves NAFLD once patients are weight stable.

NCT ID: NCT00244569 Completed - Cirrhosis Clinical Trials

Development of a Breath Test for Monitoring Patients With Liver Disease

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID machine in monitoring liver metabolic functions.

NCT ID: NCT00230113 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effect of Omega-3 PUFA Supplementation in NAFLD Patients

Start date: September 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids will decrease the amount of fat in liver.

NCT ID: NCT00230087 Completed - Diabetes Mellitus Clinical Trials

Iron Depletion Therapy for Type 2 DM and NAFLD

Start date: September 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether lowering the amount of iron in the body will result in less resistance to insulin and improved liver function in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease. This may result in better diabetes control and/or a decrease in the amount of liver fat.

NCT ID: NCT00229255 Completed - Obesity Clinical Trials

Relation of Obesity With Frequency of Meals (MST 0557)

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

The purpose of this study is to test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We, the researchers at Rockefeller University, hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance. This is a 6 week inpatient study.