Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD

Completed · Not applicable

Conditions studied: Fatty Liver, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT00585299

Run by

Yale University

People needed

4

Starts

2006-10-01

Expected to finish

2010-09-01

Last updated by the study team

2014-06-17

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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%)

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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