Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: No breakfast/beverage only; Other: Breakfast; Other: 10004RF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324921

BK40

Details and patient eligibility

About

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).

Enrollment: 37 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 (

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 3 patient groups, including a placebo group

No breakfast/beverage only

Placebo Comparator group

Description:

12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener

Treatment:

Other: No breakfast/beverage only

Breakfast

Active Comparator group

Description:

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

Treatment:

Other: Breakfast

10004RF

Experimental group

Description:

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

Treatment:

Other: 10004RF