Insulin Resistance in Non-alcoholic Fatty Liver Disease
Stopped early · Not applicable · Has a placebo group
Conditions studied: Fatty Liver
In brief
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.
Key facts
- Study ID
- NCT01289639
- Run by
- VA Office of Research and Development
- People needed
- 11
- Starts
- 2005-10-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2017-08-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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