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Fatty Liver clinical trials

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NCT ID: NCT00742326 Terminated - HIV Clinical Trials

Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections

Start date: August 2008
Phase: Phase 4
Study type: Interventional

This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is a drug that helps to reduce the body's resistance to insulin. It is approved by the Food and Drug Administration to treat diabetes. Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis. - Participants are randomly assigned to take either pioglitazone therapy or placebo for 48 weeks. This is followed by a second 48-week treatment period in which all participants take pioglitazone. - There are approximately 12 visits during the 96 weeks of the study. Participants will receive a physical assessment, blood and urine tests at each visit. In addition, periodic assessments of dietary habits, body composition, oral glucose tolerance testing, and health related quality of life questionnaires will be completed. - A repeat MRI of the liver is performed at 48 weeks and at the end of the study to evaluate any potential changes in liver fat and inflammation. In addition, there is a follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.

NCT ID: NCT00740610 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).

NCT ID: NCT00736385 Terminated - Fatty Liver Clinical Trials

Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)

NAFLD
Start date: April 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to find out if Metformin is safe and useful in the treatment of NAFLD.

NCT ID: NCT00730873 Completed - Clinical trials for Obstructive Sleep Apnea

Fatty Liver and Obstructive Sleep Apnea

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

Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography

NCT ID: NCT00714129 Completed - Diabetes Clinical Trials

De Novo Lipogenesis, Lipid and Carbohydrate Metabolism in Non-alcoholic Fatty Liver Disease

LINC
Start date: September 2007
Phase: N/A
Study type: Interventional

The worldwide epidemic of obesity is paralleled with increased cases of non-alcoholic liver disease (liver fat accumulation) and diabetes. Fat belongs in the adipose tissue, and if excess fat accumulates in the liver or muscle, these tissues cannot use sugar efficiently. It has been discovered that when large quantities of fructose (a sugar present in soft drinks) are consumed, the conversion of carbohydrate (CHO) to fat in the liver increases. We hypothesize that: 1) subjects with fatty liver have a higher CHO uptake and conversion to fat in their liver when compared to matched control subjects with normal liver fat content; and that: 2) when subjects with fatty liver are fed a diet limiting fructose and simple sugars will decrease their liver CHO fat content. This reduction in liver fat will normalize the way the liver responds to sugar and insulin, reversing the pre-diabetic state. The measurement of these parameters will be done using state-of-the-art techniques such as safe non-radioactive isotope tracers and non-invasive magnetic resonance spectroscopy. For more information, please call 415-206-5532 for a phone screening

NCT ID: NCT00706537 Completed - Clinical trials for Non-Alcoholic Steatohepatitis(NASH)

Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH

Start date: July 2008
Phase: Phase 1
Study type: Interventional

CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity. CP-945598 is also being considered as a potential treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH patients and underwrite the safety of this compound prior to any further studies in NASH patients.

NCT ID: NCT00699036 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

Start date: April 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?

NCT ID: NCT00694746 Terminated - Clinical trials for Non-alcoholic Fatty Liver Disease

Study of Fish Oil to Reduce ALT Levels in Adolescents

Start date: June 2008
Phase: Phase 1
Study type: Interventional

This trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased ALT.

NCT ID: NCT00681408 Completed - Fatty Liver Clinical Trials

Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)

Start date: March 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resistance. Therapy usually includes recommendations to increase exercise and to begin weight reducing diets but these goals are variably achieved and their relative effects in conjunction with pharmacological intervention have not been well defined. Moreover, these lifestyle changes can confound results of treatment trials if not quantified through conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially formulation rich in omega-3, are widely accepted and endorsed in the medical community for their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3 fatty acid (3gm/day) will produce improvement in NASH histological injury independent of changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The effects of the supplement will be compared to a placebo group and controlled for these lifestyle changes.

NCT ID: NCT00680407 Completed - Clinical trials for Non-alcoholic Steatohepatitis

Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis

SyNCH
Start date: April 2008
Phase: Phase 2
Study type: Interventional

Silymarin, also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this research study is to determine the effectiveness of silymarin and assess the safety of different silymarin doses in patients with varying severity of liver disease compared to a placebo (lactose pill). Following a screening visit, patients with histologically confirmed NASH will be randomized to either placebo or one of two active treatment groups of silymarin (Legalon®). One active treatment group will receive 420 mg, each dose given three times daily, the other active treatment group will receive 700 mg, each dose given three times daily. Patients will be treated for 48-50 weeks. Participation in this research study requires the patient to travel to the clinic for at least 11 visits so recruitment will be limited to a geographically restricted area around participating clinical centers. Liver biopsy must be performed up to 12 months prior to, and immediately after, the treatment phase.