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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2008

Interventions

  • Other: Nutritional Formula
    • nutritional shake daily
  • Other: Usual diet
    • usual dietary habits
  • 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

Arms, Groups and Cohorts

  • Experimental: A1
    • Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake
  • Active Comparator: A2
    • Usual diet
  • Experimental: A3
    • Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars.

Clinical Trial Outcome Measures

Primary Measures

  • Average daily blood glucose level
    • Time Frame: 11 days

Secondary Measures

  • 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
    • Time Frame: 11 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Nutrition
  • Provider of Information About this Clinical Study
    • Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
  • Overall Official(s)
    • Vikkie Mustad, PhD, Study Director, Abbott Nutrition

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