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

NCT ID: NCT00753181

Last Updated: 2009-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-03-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A1

Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake

Group Type: EXPERIMENTAL

Nutritional Formula

Intervention Type: OTHER

nutritional shake daily

A2

Usual diet

Group Type: ACTIVE_COMPARATOR

Usual diet

Intervention Type: OTHER

usual dietary habits

A3

Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars.

Group Type: EXPERIMENTAL

Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.

Intervention Type: OTHER

nutritional shake, diabetes specific cereal and diabetes snack bar daily

Interventions

Nutritional Formula

nutritional shake daily

Intervention Type: OTHER

Usual diet

usual dietary habits

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott Nutrition

Principal Investigators

Vikkie Mustad, PhD

Role: STUDY_DIRECTOR

Abbott Nutrition

Locations

Provident Clinical Research

Bloomington, Indiana, United States

Radiant Research

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

BK21

Identifier Type: -

Identifier Source: org_study_id