Diabetes Mellitus, Type 2
Conditions
Brief summary
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).
Interventions
OTHERNo breakfast/beverage only
12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
OTHERBreakfast
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
OTHER10004RF
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
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. type 2 diabetes 2. between 21 and 75 years of age 3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile 4. BMI is \> 18.5 kg/m2 and \<35 kg/m2 5. If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.
Exclusion criteria
1. Hemoglobin A1c value at screening of greater than or equal to 9%. 2. Uses exogenous insulin or exenatide for glucose control. 3. type 1 diabetes. 4. history of diabetic ketoacidosis. 5. current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 6. active malignancy 7. significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 8. end-stage organ failure or is status post organ transplant. 9. history of renal disease. 10. current hepatic disease. 11. history of severe gastroparesis. 12. chronic, contagious, infectious disease 13. taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose. 14. clotting or bleeding disorders 15. allergic or intolerant to any ingredient found in the study products. 16. habitual user of tobacco products (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive AUC for plasma glucose concentration | 0 to 180 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Plasma glucose concentrations | 0 to 180 minutes |
| Positive AUC for serum insulin concentration | 0-180 minutes |
Countries
United States
Outcome results
None listed