Insulin Resistance in Non-alcoholic Fatty Liver Disease

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to investigate the relationship between insulin resistance and non-alcoholic fatty liver disease (NAFLD) and to investigate potential mechanisms underlying insulin resistance in NAFLD by determining associations between hepatic and peripheral insulin sensitivity, hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose metabolism, beta-cell function and body fat distribution.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Fenofibrate; Insulin; Pioglitazone

Criteria

Inclusion Criteria:

Control subjects: nl liver enzymes and no history of liver disease Case subjects: NAFLD on liver biopsy within the past 3 years or presumed NAFLD with otherwise unexplained elevated alanine aminotransferase (ALT) and fatty liver by computerized tomography (CT) scan or ultrasound

• Able to comply with taking 1 pill a day for 6 months and follow-up safety visits

Exclusion Criteria:

• Cases: cirrhosis on liver biopsy or by clinical exam or fibrosis score

• Causes of liver dysfunction other than NASH

• Use of medications associated with hepatic steatosis:

• glucocorticoids

• estrogens

• tamoxifen

• amiodarone

• accutane

• sertraline

• Use of medications that cause insulin resistance:

• niacin

• glucocorticoids

• anti-HIV drugs or atypical antipsychotics

• Use of lipid-lowering medications except stable dose statin

• Use of anti-NASH drugs such as ursodeoxycholic acid, betaine milk thistle

• Use of coumadin

• Use of nitrates

• Significant alcohol consumption: Average >20 grams/day

• In subjects with diabetes, a hemoglobin A1c (HbA1c) >7.5% or use of insulin, metformin, rosiglitazone or pioglitazone

• Liver transaminases: ALT >5x upper limit of normal,

• Iron saturation >50%

• Creatinine >1.5 mg/dl for men and >1.4 mg/dl for women

• Hematocrit <33%

• Pregnancy or lactation

• Significant weight loss within the past 6 months or since the liver biopsy

• History of significant coronary artery disease or congestive heart failure, retinopathy