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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Nutritional Formula; Other: Usual diet; Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.

• Registration Number: NCT00753181
• Lead Sponsor: Abbott Nutrition

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-16
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-24
• Last Update Posted: 2009-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Nutritional Formula	Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake
A2	Usual diet	Usual diet
A3	Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.	Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars.

Primary Outcome Measures

Name	Time	Method
Average daily blood glucose level	11 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Provident Clinical Research; 🇺🇸 Bloomington, Indiana, United States

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States