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Comparison of Nutritional Products for People With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797069
First Posted: November 25, 2008
Last Update Posted: July 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott Nutrition
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nutritional Products for People With Type 2 Diabetes

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bobbie Swearengin, Director Clinical Research, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00797069     History of Changes
Other Study ID Numbers: BK20
First Submitted: November 23, 2008
First Posted: November 25, 2008
Last Update Posted: July 30, 2010
Last Verified: March 2010

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