Comparison of Nutritional Products for People With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: standard nutritional product (medical food); Other: nutritional product for diabetes (medical food); Other: diabetes specific experimental nutritional product (medical food)

• Registration Number: NCT00797069
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-23
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2009-02
• Study Completion: 2009-07
• Status Verified: 2010-03
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
standard nutritional product	standard nutritional product (medical food)	Standard nutritional product not specific for diabetes
diabetes specific product	nutritional product for diabetes (medical food)	Diabetes specific nutritional product
Experimental diabetes specific product	diabetes specific experimental nutritional product (medical food)	Diabetes specific experimental nutritional product

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Malaga, Spain