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| Name | Class |
|---|---|
| University of Brasilia | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Fund to support research of the Federal District, Brazil | UNKNOWN |
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The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research on Glycemic Index (GI) diets has been largely developed, however the combination with metformin in humans was not investigated yet. We hypothesized that the low-GI diet in combination with metformin would elicit greater improvements on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects. This study aims to evaluate the metabolic effects of the adoption of dietary advice to follow caloric restriction high/low GI diets, and low-GI diet associated with metformin on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects.
All groups (Low/High-GI and Low-GI + Metformin) showed significant reduction in anthropometric parameters, but only Low-GI and Low-GI + Metformin groups have an improvement in body composition parameters. In addition, the Low-GI group achieved better results in metabolism of carbohydrates (glucose, insulin, Cederholm Index, and HOMA-β) and lipids (Chol, TAG, LDL-C, VLDL-C, and TC/HDL-c). These results show the benefits of Low-GI diet on metabolic parameters in overweight or obese type 1 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Glycemic Index | Other | Hypocaloric diet with predominating high glycemic index foods |
|
| Low Glycemic Index | Other | Hypocaloric diet with predominant low glycemic index foods |
|
| Low Glycemic Index plus Metformin | Other | Hypocaloric diet with predominant low glycemic index foods plus Metformin (1g/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycemic Index Diets and Metformin hydrochloride | Other | 1g of Metformin hydrochloride a day in High Glycemic Index Diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Metabolism | 2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index. | 0 and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Profile | Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio | 0 and 4 months |
| Body Composition | Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa HM da Costa, Ph.D. | University of Brasilia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Health Sciences, University of BrasÃlia | BrasÃlia | Federal District | 70910-900 | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| 0 and 4 months |
| Clinical Assessment | FSH hormone, urea, creatinine, and uric acid urinary levels | 0 and 4 months |
| Food Intake | Energy intake, macronutrients and fiber consumption | 0 and 4 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |