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

Sponsors and Collaborators:	Yale University National Institutes of Health (NIH)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00585299

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

MedlinePlus related topics: Obesity Obesity in Children Weight Control

Drug Information available for: Insulin Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD

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
Low-fat diet: Experimental 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
Traditional: Active Comparator 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

Contacts

Contact: Mary Savoye, RD	203-737-4384	mary.savoye@yale.edu
Contact: Sonia Caprio, MD	203-764-9199	sonia.caprio@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Mary Savoye, RD 203-737-4384 mary.savoye@yale.edu
Contact: Sonia Caprio, MD 203-764-9199 sonia.caprio@yale.edu

Sponsors and Collaborators

Yale University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Sonia Caprio, MD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Sonia Caprio, MD )
Study ID Numbers:	0212023115, R01-HD40787-01
Study First Received:	December 22, 2007
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00585299
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

steatosis
fatty liver
insulin sensitivity
fatty liver (steatosis)

Study placed in the following topic categories:

Obesity
Liver Diseases
Metabolic Diseases
Fatty Liver
Insulin
Body Weight
Hyperinsulinism

Signs and Symptoms
Digestive System Diseases
Weight Loss
Body Weight Changes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009