Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753181
• Other study ID #: BK21
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2008
• Last updated: April 24, 2009
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. type 2 diabetes

2. HbA1c >6.5% and <11.0%

3. male/non-pregnant, non-lactating female, at least 6 months postpartum

4. if female of childbearing potential, practicing method of birth control

5. Body Mass Index > 18.5 kg/m2 and < 43.0 kg/m2.

6. weight stable for past two months

7. if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months

Exclusion Criteria:

1. uses injected medications (e.g., insulin, exenatide) for glucose control.

2. history of diabetic ketoacidosis

3. current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks

4. active malignancy

5. states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.

6. end stage organ failure

7. active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.

8. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

9. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.

10. symptomatic in response to blood collection prior to enrollment into this study.

11. clotting or bleeding disorders.

12. non-typical eating pattern

13. is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.

14. engages in strenuous exercise five or more times per week.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Nutritional Formula
nutritional shake daily
• Usual diet
usual dietary habits
• Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.
nutritional shake, diabetes specific cereal and diabetes snack bar daily

Locations

Country	Name	City	State
United States	Provident Clinical Research	Bloomington	Indiana
United States	Radiant Research	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily blood glucose level		11 days	No
Secondary	Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables		11 days	No