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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00585299
First received: December 22, 2007
Last updated: July 23, 2009
Last verified: July 2009
History of Changes
  Purpose

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 Intervention
Fatty Liver
Insulin Resistance
 Other: Low-fat diet
Other: Traditional diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Liver Enzyme, liver and muscle fat content, glucose tolerance status [ Time Frame: 16-18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma lipid levels [ Time Frame: 16-18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2006
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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%)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585299

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Sonia Caprio, MD Yale University
  More Information

No publications provided

Responsible Party: Sonia Caprio, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00585299     History of Changes
Other Study ID Numbers: 0212023115, R01-HD40787-01
Study First Received: December 22, 2007
Last Updated: July 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
steatosis
fatty liver
insulin sensitivity
fatty liver (steatosis)

Additional relevant MeSH terms:
Fatty Liver
Insulin Resistance
Weight Loss
Liver Diseases
Digestive System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Body Weight Changes
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013