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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No breakfast/beverage only; Other: Breakfast; Other: 10004RF

• Registration Number: NCT01324921
• Lead Sponsor: Abbott Nutrition

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-03
• Study First Submitted: 2011-03-27
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Last Update Submitted: 2011-03-29
• Last Update Posted: 2011-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 (

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No breakfast/beverage only	No 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
Breakfast	Breakfast	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	10004RF	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

Primary Outcome Measures

Name	Time	Method
Positive AUC for plasma glucose concentration	0 to 180 minutes

Secondary Outcome Measures

Name	Time	Method
Plasma glucose concentrations	0 to 180 minutes
Positive AUC for serum insulin concentration	0-180 minutes

Trial Locations

Locations (2)

Provident Clinical Research and Consulting LLC; 🇺🇸 Glen Ellyn, Illinois, United States

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States