Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
Phase 3
Completed
- Conditions
- Diabetes Mellitus Type 2
- Registration Number
- NCT00540488
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- signed and dated informed consent
- 18-75 years of age
- history of type 2 diabetes
- males and non-pregnant, non-lactating females
Exclusion Criteria
- subject uses insulin for glucose control
- significant cardiovascular event <12 weeks prior to study entry
- active malignancies
- history of end stage renal disease
- history of organ transplant
- current hepatic disease
- intervention for HIB
- takes niacin
- history of gastroparesis
- active disease that may interfere with nutrient intake
- allergy or intolerance to ingredients in the study products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Adjusted area under the curve (adj-AUC) of glucose response 0-240 minutes
- Secondary Outcome Measures
Name Time Method Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance 0 - 240 minutes
Trial Locations
- Locations (2)
Medical University of South Carolina
🇺🇸Charleston, North Carolina, United States
Protocare Trials, Chicago Center for Clinical Research
🇺🇸Chicago, Illinois, United States