Diabetes Mellitus Type 2
Conditions
Brief summary
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
Interventions
OTHERAdult enteral formula
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adjusted area under the curve (adj-AUC) of glucose response | 0-240 minutes |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed