Comparison of Nutritional Products for People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Comparison of Nutritional Products for People With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797069
• Other study ID #: BK20
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2008
• Last updated: July 29, 2010
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• standard nutritional product (medical food)
once during crossover
• nutritional product for diabetes (medical food)
once during crossover
• diabetes specific experimental nutritional product (medical food)
once during crossover

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No