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To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No breakfast/beverage only | Placebo Comparator | 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener |
|
| Breakfast | Active Comparator | 1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener |
|
| 10004RF | Experimental | 1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No breakfast/beverage only | Other | 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener |
| Measure | Description | Time Frame |
|---|---|---|
| Positive AUC for plasma glucose concentration | 0 to 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose concentrations | 0 to 180 minutes | |
| Positive AUC for serum insulin concentration | 0-180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Devitt-Maicher, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provident Clinical Research and Consulting LLC | Glen Ellyn | Illinois | 60137 | United States | ||
| Radiant Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32449201 | Derived | Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2. |
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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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| ID | Term |
|---|---|
| D062408 | Breakfast |
| ID | Term |
|---|---|
| D062407 | Meals |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Breakfast | Other | 1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener |
|
| 10004RF | Other | 1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener |
|
| Cincinnati |
| Ohio |
| 45249 |
| United States |
| D004700 | Endocrine System Diseases |
| D019602 |
| Food and Beverages |