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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00585299

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver Insulin Resistance	Other: Low-fat diet Other: Traditional diet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: Low-fat diet 20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks Other: Traditional diet Traditional low-fat diet with dietitian follow-up in 16 weeks
Active Comparator: Traditional Traditional low-fat diet given and dietitian follows up in 16 weeks	Other: Traditional diet Traditional low-fat diet with dietitian follow-up in 16 weeks

Arm

Intervention/Treatment

Experimental: 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

Other: Low-fat diet

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

Other: Traditional diet

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

Active Comparator: Traditional

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

Other: Traditional diet

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

Outcome Measures

Primary Outcome Measures

Liver Enzyme, liver and muscle fat content, glucose tolerance status [16-18 weeks]

Secondary Outcome Measures

plasma lipid levels [16-18 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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%)