Insulin Resistance in Non-alcoholic Fatty Liver Disease
Stopped early · Not applicable · Has a placebo group
Conditions studied: Fatty Liver, Insulin Resistance
In brief
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.
Key facts
- Study ID
- NCT00252499
- Run by
- US Department of Veterans Affairs
- People needed
- 13
- Starts
- 2005-10-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2014-08-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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