Diabetes Mellitus, Type 2
Conditions
Brief summary
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
Interventions
OTHERstandard nutritional product (medical food)
once during crossover
OTHERnutritional product for diabetes (medical food)
once during crossover
OTHERdiabetes specific experimental nutritional product (medical food)
once during crossover
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
1. Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months). 2. Subject is between 18 and 75 years of age, inclusive. 3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 4. If female is of childbearing potential, is practicing a method of birth control. 5. Subject's BMI is \> 18.5 kg/m2 and \< 35 kg/m2. 6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
Exclusion criteria
1. Subject uses exogenous insulin for glucose control. 2. Subject states that he/she has type 1 diabetes. 3. Subject states that he/she has a history of diabetic ketoacidosis. 4. Subject takes an alpha-glucosidase inhibitor. 5. Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 6. Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix). 7. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 8. Subject states that he/she has end stage organ failure or is status post organ transplant. 9. Subject states that he/she has a history of renal disease. 10. Subject states that he/she has current hepatic disease. 11. Subject states that he/she has a history of severe gastroparesis. 12. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 13. Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose. 14. Subject states that he/she has clotting or bleeding disorders. 15. Subject is known to be allergic or intolerant to any ingredient found in the study products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. | Three crossover periods |
Secondary
| Measure | Time frame |
|---|---|
| To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. | Three crossover periods |
Countries
Spain
Outcome results
None listed