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

NCT00585299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2014-06-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Sonia Caprio, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585299 on ClinicalTrials.gov