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Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.
Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| #1 | Experimental | Diabetes specific enteral product |
|
| #2 | Active Comparator | Standard enteral feeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral nutritional formula | Other | Meal glucose tolerance test |
| |
| Diabetes specific enteral product |
| Measure | Description | Time Frame |
|---|---|---|
| Positive area under the curve (AUC) for plasma glucose and mean glucose level | 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration | 240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C. Maki, PhD | Provident Clinical Research and Consulting, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provident Clinical Research and Consulting, Inc. | Bloomington | Indiana | 47403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20470226 | Derived | Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25. doi: 10.1089/dia.2009.0185. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Other |
Meal Glucose tolerance test |
|
| D004700 | Endocrine System Diseases |