Clinical trial NCT00797069: Comparison of Nutritional Products for People With Type 2 Diabetes
Official title: Comparison of Nutritional Products for People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Three crossover periods
Secondary outcomes:
measure: 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.
timeFrame: Three crossover periods
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MS
role: STUDY_CHAIR
References: