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| Name | Class |
|---|---|
| Adventia Pharma | INDUSTRY |
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Rationale: The aim of the study was to compare the glycemic and insulinemic response of malnourished patients with type 2 diabetes after oral feed between a diabetic oral nutritional supplements (ONS) and a standard one.
Methods: Randomized, double-blind, crossover, multicenter clinical trial, conducted in patients with type 2 diabetes and a diagnosis of malnutrition (SGA). Patients were randomized to receive two ONS: diabetic (Bi1 diacare hp/hc) or control (standard, isocaloric and isoproteic), a week apart. A glycemia and insulinemia curve was made at times: 0', 30', 60', 90', 120', and 180', after drank 200 ml of the ONS. The analyzed variables were the area under the curve (AUC 0-t) of glucosa and insulin, and the maximum concentration of glucose (Cmax).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi1 diacare hp-hc | Experimental | During 6 days, patients received 2 ONS of a specific formula for diabetes, high energy (300 kcal/unit) and high protein (20%), with fiber, EPA&DHA, EVOO and a specific mix of low glycemic index of carbohydrate |
|
| Control | Active Comparator | During 6 days, patients received 2 ONS of a standar formula, high energy (300 kcal/unit) and high protein (20%), without fiber, without EPA&DHA, without EVOO and without a specific mix of low glycemic index of carbohydrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetic | Dietary Supplement | It is a hypercaloric and hyperproteic dietary supplement formulated to contribute to control the glycemia with: a specific mix of carbohydrate with a low GI, fiber, EVOO and EPA&DHA |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemic response | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial insulin response | 180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| José M. GarcÃa Almeida | Málaga | Spain |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003927 | Diet, Diabetic |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Randomized, crossover, double blind, multicenter, clinical trial
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| Control | Dietary Supplement | It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control |
|
| D004700 | Endocrine System Diseases |
| D009748 | Nutrition Disorders |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |