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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD040787-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Traditional | Active Comparator | Traditional low-fat diet given and dietitian follows up in 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-fat diet | Other | 20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Enzyme, liver and muscle fat content, glucose tolerance status | 16-18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| plasma lipid levels | 16-18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonia Caprio, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Traditional diet | Other | Traditional low-fat diet with dietitian follow-up in 16 weeks |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |