Status:
TERMINATED
Insulin Resistance in Non-alcoholic Fatty Liver Disease
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Fatty Liver
Insulin Resistance
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
NAFLD and nonalcoholic steatohepatitis (NASH) are common liver disorders that are strongly associated with obesity, type 2 diabetes and dyslipidemia. The underlying pathophysiology of fatty infiltrati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00252499
Start Date
October 1 2005
End Date
August 1 2010
Last Update
August 20 2014
Active Locations (1)
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1
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108