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Comparison of Nutritional Products for People With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00797069
First received: November 23, 2008
Last updated: July 29, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Other: standard nutritional product (medical food)
Other: nutritional product for diabetes (medical food)
Other: diabetes specific experimental nutritional product (medical food)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nutritional Products for People With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • 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. [ Time Frame: Three crossover periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Three crossover periods ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard nutritional product
Standard nutritional product not specific for diabetes
 Other: standard nutritional product (medical food)
once during crossover
Active Comparator: diabetes specific product
Diabetes specific nutritional product
 Other: nutritional product for diabetes (medical food)
once during crossover
Experimental: Experimental diabetes specific product
Diabetes specific experimental nutritional product
 Other: diabetes specific experimental nutritional product (medical food)
once during crossover

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797069

Locations
Spain
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Jennifer Williams, MS Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Director Clinical Research, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00797069     History of Changes
Other Study ID Numbers: BK20
Study First Received: November 23, 2008
Last Updated: July 29, 2010
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013