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

NCT ID: NCT00585299

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-09-30

Brief 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.

Detailed 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.

Conditions

Fatty Liver; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-fat diet

20% kcals from fat diet followed for 8 weeks then 8 weeks of maintenance diet with visits to dietitian every other week

Group Type: EXPERIMENTAL

Low-fat diet

Intervention Type: OTHER

20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks

Traditional diet

Intervention Type: OTHER

Traditional low-fat diet with dietitian follow-up in 16 weeks

Traditional

Traditional low-fat diet given and dietitian follows up in 16 weeks

Group Type: ACTIVE_COMPARATOR

Traditional diet

Intervention Type: OTHER

Traditional low-fat diet with dietitian follow-up in 16 weeks

Interventions

Low-fat diet

20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks

Intervention Type: OTHER

Traditional diet

Traditional low-fat diet with dietitian follow-up in 16 weeks

Intervention Type: OTHER

Eligibility Criteria

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%)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Caprio, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R01HD040787-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0212023115

Identifier Type: -

Identifier Source: org_study_id