Type 2 Diabetes Mellitus
Conditions
Brief summary
Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes. Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.
Interventions
OTHERenteral nutritional formula
Meal glucose tolerance test
OTHERDiabetes specific enteral product
Meal Glucose tolerance test
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
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent form * Type 2 diabetes * 18 to 75 years of age * Male or non-pregnant, non-lactating female, at least 6 weeks postpartum * If female is of childbearing potential, is practicing birth control * BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2 * Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit
Exclusion criteria
* Uses exogenous insulin for glucose control * Type 1 diabetes * History of diabetic ketoacidosis * Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks * Active malignancy * Significant cardiovascular event less than 12 weeks prior to study entry * End stage organ failure or is status post organ transplant * Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes * Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV * Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose * Fainted or experienced other adverse reactions in response to blood collection prior to this study * Has clotting or bleeding disorders * Allergic or intolerant to any ingredient found in the study products * Participant in a concomitant trial that conflicts with this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive area under the curve (AUC) for plasma glucose and mean glucose level | 240 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration | 240 minutes |
Countries
United States
Outcome results
None listed