Clinical trial NCT00585299: Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Official title: Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Insulin Resistance
Keywords: steatosis
fatty liver
insulin sensitivity
fatty liver (steatosis)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-01-03
Enrollment: 4
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%)

Primary outcomes:
measure: Liver Enzyme, liver and muscle fat content, glucose tolerance status
timeFrame: 16-18 weeks
Secondary outcomes:
measure: plasma lipid levels
timeFrame: 16-18 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Sonia Caprio, MD
role: PRINCIPAL_INVESTIGATOR
References: