Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT00529204
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years, \< 70 years, inclusive
* Type 2 diabetes on stable doses of sulfonylurea and/or metformin
* Body mass index \> 35 kg/m2
* Presumed diagnosis of NAFLD based upon
* an ALT \> 1.5 times the upper limit of reference range,
* no evidence of other causes of liver disease and
* ultrasound findings compatible with fatty liver
Exclusion Criteria:
* Clinical signs of cirrhosis as evidenced by any of the following
* spider angiomata,
* splenomegaly,
* ascites
* jaundice
* encephalopathy
* INR \> 1.2
* Platelet count \< 100,000/ml
* Serum albumin \< 3.0 g/dL
* Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis.
* Current use of \> 20 g of alcohol per day or unwillingness to avoid alcohol during the course of the study
* Treatment with a thiazolidinedione or exenatide within 6 months of enrolling in the study
* AST or ALT \> 10 times the upper limit of normal
* Treatment with any investigational drug within 4 weeks of enrollment
* Pre-menopausal, fertile women unwilling to use contraceptives during the study period.
* Pregnancy or lactation
* Initiation or change in dose of hypolipidemic drugs (statins, niacin, cholestyramine are allowed) within 6 months of enrollment
* Use of anticoagulation, bleeding disorders or other contraindications to liver biopsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00529204
Study Brief:
Protocol Section:
NCT00529204