Insulin Resistance Clinical Trial
Official title:
Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Verified date | June 2014 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes.
Status | Completed |
Enrollment | 4 |
Est. completion date | September 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 10 Years to 21 Years |
Eligibility |
Inclusion Criteria: - 10 to 21 yrs of age - Non-smoking - BMI >95th percentile for age and gender, but BMI <40 - Suspicion of fatty liver, with a high ALT (>35) - Normal glucose tolerance or prediabetes (impaired glucose tolerance or impaired fasting glucose) Exclusion Criteria: - Females of child-bearing potential who are not using birth control - Pregnant or lactating females - Current medications except oral anti-diabetic medications and hormonal birth control - Lipid-lowering medication that increases liver enzymes - Significant kidney dysfunction (creatinine >1.5 mg/dL) - Current heavy ethanol use or recent history of binge drinking - History or evidence of hepatitis A, B, or C, Wilson's Disease, or alpha-1-antitrypsin deficiency - Known to be HIV positive - Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA classification as Functional Class III or IV - Major vascular event within 6 months of screening (e.g. MI, stroke) - Active cancer within 5 years prior to screening - Current systemic disease, including type 1 or 2 diabetes - Enrolled in another research study within 1 month prior to screening - Implanted paramagnetic material (all subjects will need to fill out the Yale Magnetic Resonance Center safety checklist) - Anemia (HCT <35%) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Yale University School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver Enzyme, liver and muscle fat content, glucose tolerance status | 16-18 weeks | No | |
Secondary | plasma lipid levels | 16-18 weeks | No |
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