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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324921
• Other study ID #: BK40
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 27, 2011
• Last updated: March 29, 2011
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• 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
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
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

Locations

Country	Name	City	State
United States	Radiant Research	Cincinnati	Ohio
United States	Provident Clinical Research and Consulting LLC	Glen Ellyn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive AUC for plasma glucose concentration		0 to 180 minutes	No
Secondary	Plasma glucose concentrations		0 to 180 minutes	No
Secondary	Positive AUC for serum insulin concentration		0-180 minutes	No