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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK070777 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes.
This research is a randomized controlled trial to compare long-term outcomes behavioral weight loss interventions that include either low-fat or low-glycemic load dietary instruction. Targets for energy intake and expenditure, and behavioral skills taught, are identical across the two diets. Additionally, both treatments include 20 weekly group sessions, followed by 10 every-other-week sessions. Participants are overweight and obese adults with type 2 diabetes. The primary outcomes are changes in weight and glycated hemoglobin. Those randomized to the low-glycemic load diet are expected to achieve greater weight losses and maintain better glycemic control at the end of treatment (i.e., week 40) and after 1 year of no-treatment follow-up (i.e., week 92).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low-Glycemic Load Diet |
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| 2 | Active Comparator | Low-Fat Diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Modification | Behavioral | Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change in weight | 92 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 92 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony N Fabricatore, Ph.D. | University of Pennsylvania | Principal Investigator |
| Thomas A Wadden, Ph.D. | University of Pennsylvania | Study Director |
| Virginia A Stallings, M.D. | Children's Hospital of Philadelphia | Study Director |
| Stanley Schwartz, M.D. | University of Pennsylvania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, Center for Weight and Eating Disorders | Philadelphia | Pennsylvania | 19104-3309 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |