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

Abbott

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Usual diet; Other: Nutritional Formula; Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00753181

BK21

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

A1

Experimental group

Description:

Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake

Treatment:

Other: Nutritional Formula

A2

Active Comparator group

Description:

Usual diet

Treatment:

Other: Usual diet

A3

Experimental group

Description:

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

Treatment:

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