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Fatty Liver clinical trials

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NCT ID: NCT00401336 Completed - Hepatitis C Clinical Trials

Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

SURFER
Start date: November 2006
Phase: N/A
Study type: Interventional

Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. The aim of the study is to use a simplified magnetic resonance imaging (MRI) technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically.

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NCT ID: NCT00375349 Withdrawn - Clinical trials for Non-alcoholic Fatty Liver Disease (NAFLD)

Non Alcoholic Fatty Liver Disease Influence of Statin Therapy

Start date: September 2006
Phase: N/A
Study type: Interventional

Aim: 1. To determine the prevalence of fatty liver in a cohort of patients hospitalized with chest pain in the Cardiology department. 2. To assess the effect of statins on the prevalence of fatty liver by a cross sectional survey of patients hospitalized with chest pain.

NCT ID: NCT00326482 Active, not recruiting - Liver Fibrosis Clinical Trials

Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy

Start date: July 31, 2006
Phase:
Study type: Observational

This study will provide a basis for research on the impact of liver injury caused by antiretroviral therapy in HIV-infected patients. Elevated liver enzymes called AST and ALT are common in HIV-infected patients taking antiretroviral medications and can indicate liver damage. Although there are a number of possible causes for these elevations, such as infections with a hepatitis virus, antiretroviral medications alone can lead to the elevations. The study will focus particularly on evidence of liver fibrosis, which is a sign of progressive liver damage. HIV-infected patients 18 and older who 1) have been taking combination antiretroviral therapy for at least 12 months and have been on a stable regimen for at least 3 months, and 2) have had elevated AST or ALT levels for at least 6 months may be eligible for this study. Patients who have had liver biopsies performed in the past may be eligible for participation. Participants undergo the following tests and procedures over a 12-month period: - Oral glucose tolerance test: The patient drinks a glucose (sugar) drink. Blood samples are then drawn over 2 hours through an intravenous (IV) line in the patient's arm. This test measures how high the patient's blood sugar and insulin levels rise after drinking a standard glucose load. - Transient elastography: This ultrasound test uses vibration (sound waves) to measure liver stiffness (fibrosis). Vibrations move faster through a fibrotic liver. - Triple-phase CT scan and single slice CT scan of L4-5: Patients fast for 4 hours before the CT scan. A contrast material is injected through a catheter placed in an arm vein to improve the visibility of the liver in the specialized X-ray images obtained in the CT scanner. - Liver biopsy: This test removes a small sample of liver tissue for microscopic examination, particularly for evidence of fibrosis. The skin over the biopsy site is numbed and a needle is passed through the skin and rapidly in and out of the liver. Patients may be given a sedative for the procedure. - Follow-up visits. Patients return for follow-up visits 1 to 4 weeks after the liver biopsy and three more times over the course of the study for a medical history, physical examination and blood tests. Patients may participate in an additional 4-year follow-up, during which they have visits every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year after the first biopsy.

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: NCT00303537 Active, not recruiting - Fatty Liver Clinical Trials

Metformin in Non-Alcoholic Fatty Liver Disease

Start date: November 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.

NCT ID: NCT00274495 Terminated - Fatty Liver Clinical Trials

Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver

Start date: January 2006
Phase: Phase 4
Study type: Interventional

To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are being treated with standard therapy. Standard therapy consists of weekly pegylated interferon injections and daily ribavirin pills, whose dosage is weight based. This regimen in genotype 1 patients is effective in only 45% of patients at best. In addition, this therapy must be given for 48 weeks to be effective and has alot of side-effects. One risk factor for a poor response is fatty liver. Rosiglitazone has been shown to be effective in the treatment of patients with fatty liver alone. This study hopes to show that the addition of Rosiglitazone to the standard therapy in genotype 1 patients with fatty liver disease will increase effectiveness of the standard therapy of hepatitis C.

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.