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OpenTrials
Completed

NCT Number: NCT00585299

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

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.

Completed

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Key information

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Low-Fat Diet

Other

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

Traditional diet

Other

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

Primary outcomes

  1. Liver Enzyme, liver and muscle fat content, glucose tolerance status

    Time frame: 16-18 weeks

Secondary outcomes

  1. plasma lipid levels

    Time frame: 16-18 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 3, 2008
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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