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Fatty Liver clinical trials

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NCT ID: NCT01066364 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

Start date: February 2010
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT01051219 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Anti-Fibrotic Effects of Losartan In Nash Evaluation Study

FELINE
Start date: May 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, controlled trial to determine whether Losartan is effective at slowing down, halting or reversing liver fibrosis in patients with non-alcoholic steatohepatitis (NASH). Liver fibrosis is the accumulation of tough, fibrous scar tissue in the liver which occurs in patients with NASH. NASH resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage, which may lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to function properly. Primary hypothesis: That losartan is superior to placebo in reversing, slowing down or halting fibrosis in patients with non-alcoholic fatty liver disease, after 24 months of treatment. Secondary hypothesis: 1. That the safety profile of the angiotensin receptor blocker (losartan) in this patient population is acceptable 2. That losartan can prevent clinical deterioration in non-alcoholic fatty liver disease 3. That serum, radiological and histological markers of fibrosis correlate in these patients over a 24 month period

NCT ID: NCT01045499 Completed - Metabolic Syndrome Clinical Trials

LAGB as a Treatment for Morbid Obesity in Adolescents

Start date: September 13, 2005
Phase: N/A
Study type: Interventional

Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.

NCT ID: NCT01038102 Completed - Obesity Clinical Trials

Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance

HEPFAT
Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects

NCT ID: NCT01030484 Completed - Liver Disease Clinical Trials

Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database 2

Start date: December 2, 2009
Phase:
Study type: Observational

The NAFLD Database 2 will recruit at least 1,500 new adult participants suspected or known to have NAFLD or nonalcoholic steatohepatitis (NASH)-related cirrhosis and will also invite adult participants from the prior NAFLD Database and related studies (PIVENS trial and TONIC trial) to enroll in the NAFLD Database 2. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.

NCT ID: NCT01016418 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Bovine Colostrum for Patients With Non Alcoholic Fatty Liver Disease

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Trial Synopsis: Bovine Colostrum for patients with non alcoholic fatty liver disease (NAFLD). Design: This is a single-arm, open-label, before-and after exploratory trial of 30 days of Bovine Colostrum Powder (BCP) to improve NAFLD and the metabolic syndrome. Duration: 8 weeks per subject. Sample Size: 30 subjects. Population: Patients with biopsy proven NASH (NAS of > 4) and an ALT level of ≥ 30 (U/L). Regimen Study treatment will consist of BCP, three 1.2 g oral tablets (equivalent to 600 mg of BCP each) for 4 weeks, from cows immunized to insulin. Patients will be followed for safety monitoring for an additional 4 weeks.

NCT ID: NCT01007955 Completed - Insulin Resistance Clinical Trials

Assessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery

Start date: November 2006
Phase: N/A
Study type: Observational

The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for gene patterns which may be responsible for where we carry fat on our bodies, as well as look carefully at a possible link between adipose tissue and insulin resistance. The researchers also want to evaluate the liver for the presence of fatty liver, which is common in people with obesity and is associated with insulin resistance, as well as study the liver for gene patterns which may be associated with non-alcoholic liver disease. Evaluating cardiovascular function and endocrine function before and after gastric bypass surgery, as well as studying adipose and liver tissue may help us understand the link between obesity, insulin resistance, fatty liver disease, high blood pressure and health problems such as diabetes and heart disease. Consequently, this may help in the future by identifying those who will benefit most from gastric bypass surgery.

NCT ID: NCT01006889 Completed - Clinical trials for Type 2 Diabetes Mellitus

Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease

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

The primary aim of the study is to determine the impact on hepatic steatosis of replacing premeal rapid-acting insulin for exenatide (Byetta) while maintaining bedtime long-acting detemir (Levemir) insulin in well-controlled patients with type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD). Secondary aims are to learn: 1) the efficacy and safety of such approach and whether it is an acceptable treatment strategy compared to intensified insulin therapy alone; 2) mechanisms of action (i.e., effects on insulin secretion and insulin action); 3) its impact on weight (i.e., can it prevent insulin-associated weight gain or cause weight loss) and rates of hypoglycemia; 4) if it may improve specific plasma biomarkers of disease activity in NAFLD and inflammatory markers common to both conditions - T2DM and NAFLD (i.e., hsCRP, ICAM, VCAM, etc.).

NCT ID: NCT01002547 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanics With Diabetes Mellitus Type 2 (T2DM) and Role of Treatment

VA NASH
Start date: June 24, 2010
Phase: Phase 4
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition frequently associated with type 2 diabetes (T2DM) and characterized by insulin resistance and hepatic fat accumulation. Liver fat may range from simple steatosis to severe steatohepatitis with necroinflammation and variable degrees of fibrosis (nonalcoholic steatohepatitis or NASH). Up to 40% of patients with NAFLD develop NASH in recent series. Risk factors for progression to NASH are unclear, but appears to be more common and progress more rapidly in older individuals, and in the presence of obesity and T2DM. Because the VA population in San Antonio, Texas, frequently combine these risk factors for NASH it was felt that a study targeting this very high-risk population was needed. This study will establish the long-term efficacy (primary endpoint: liver histology) and safety of pioglitazone for the treatment of VA patients with T2DM and NASH. All patients diagnosed with NASH will be offered lifestyle modification/weight loss (current standard of care) while being randomized to pioglitazone, vitamin E or placebo for up to 3 years. We believe that in such a high-risk population for complications from NASH, a substantial benefit may be expected from early detection and treatment. Specifically, the arms are: a) pioglitazone + vitamin E; b) vitamin E + placebo of pioglitazone; c) placebo of both. Patients are randomized to one of these 3 arms, and followed in a double-blind fashion for up to 18 months. Patients are then offered to continue into an open-label phase with pioglitazone + vitamin E or vitamin E alone for another 18 months.

NCT ID: NCT00994682 Completed - Clinical trials for Type 2 Diabetes Mellitus

University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)

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

Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone improves glucose/lipid metabolism and histology in NASH by improving insulin resistance in the liver/peripheral/adipose tissues and reducing subclinical inflammation. The aim of this study is to assess the underlying mechanisms at the clinical and molecular level and the long-term efficacy and safety of pioglitazone in NASH in a multiethnic cohort of subjects (predominantly Hispanics, Caucasians and African-Americans - the most common ethnic groups locally) and examine the response including patients with normal glucose tolerance, impaired glucose tolerance or established type 2 diabetes mellitus (T2DM).