Insulin Resistance in Non-alcoholic Fatty Liver Disease

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether nonalcoholic fatty liver disease (NAFLD) is associated with altered peripheral and hepatic insulin sensitivity 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: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Fenofibrate; Insulin; Insulin, Globin Zinc; Rosiglitazone

Criteria

Inclusion Criteria:

• Age 18-80 years old Controls:

• otherwise healthy Case subjects: NAFLD on liver biopsy within the past 3 years or presumed NAFLD with otherwise unexplained elevated ALT and fatty liver by CT or ultrasound

• Able to comply with taking 3 pills a day for 6 months and follow-up safety visits

Exclusion Criteria:

• Controls:

• history or evidence of hepatic steatosis

• 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 HbA1c >7.5% or use of insulin

• metformin

• rosiglitazone or pioglitazone

• Liver transaminases:

• Cases: ALT >5x upper limit of normal

• Controls: ALT or AST above the normal range

• 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 for controls, or since the liver biopsy for case subjects, history of significant coronary artery disease or congestive heart failure

• Retinopathy