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Sponsors and Collaborators: |
Yale University National Institutes of Health (NIH) |
Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00585299 |
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 |
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 |
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
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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
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Traditional: Active Comparator
Traditional low-fat diet given and dietitian follows up in 16 weeks
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Other: Traditional diet
Traditional low-fat diet with dietitian follow-up in 16 weeks
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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.
Ages Eligible for Study: | 10 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Savoye, RD | 203-737-4384 | mary.savoye@yale.edu |
Contact: Sonia Caprio, MD | 203-764-9199 | sonia.caprio@yale.edu |
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 |
Yale University |
National Institutes of Health (NIH) |
Principal Investigator: | Sonia Caprio, MD | Yale University |
Responsible Party: | Yale University School of Medicine ( Sonia Caprio, MD ) |
Study ID Numbers: | 0212023115, R01-HD40787-01 |
First Received: | December 22, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00585299 |
Health Authority: | United States: Institutional Review Board |
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