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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585299
• Other study ID #: 0212023115
• Secondary ID: R01HD040787-01
• Status: Completed
• Phase: N/A
• First received: December 22, 2007
• Last updated: June 16, 2014
• Start date: October 2006
• Est. completion date: September 2010

Study information

• Verified date: June 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study will have two groups: one group that eats a moderate calorie, low-fat diet and is weighed regularly (every other week for 16 weeks) and the other who receives traditional diet therapy and returns in 16 weeks. Both groups will undergo procedures that test glucose tolerance and measure liver and muscle fat content before and after study period.

Recruitment information / eligibility

• 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%)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance

Intervention

Other:
• Low-fat diet
20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks
• Traditional diet
Traditional low-fat diet with dietitian follow-up in 16 weeks

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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