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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:
NCT00520065
First received: August 21, 2007
Last updated: July 2, 2008
Last verified: August 2007
History of Changes
  Purpose

Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.

Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Other: enteral nutritional formula
Other: Diabetes specific enteral product
 Phase 2

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:
  • Positive area under the curve (AUC) for plasma glucose and mean glucose level [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: #1
Diabetes specific enteral product
 Other: Diabetes specific enteral product
Meal Glucose tolerance test
Active Comparator: #2
Standard enteral feeding
 Other: enteral nutritional formula
Meal glucose tolerance test

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent form
  • Type 2 diabetes
  • 18 to 75 years of age
  • Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
  • If female is of childbearing potential, is practicing birth control
  • BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
  • Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit

Exclusion Criteria:

  • Uses exogenous insulin for glucose control
  • Type 1 diabetes
  • History of diabetic ketoacidosis
  • Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
  • Active malignancy
  • Significant cardiovascular event less than 12 weeks prior to study entry
  • End stage organ failure or is status post organ transplant
  • Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
  • Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
  • Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
  • Fainted or experienced other adverse reactions in response to blood collection prior to this study
  • Has clotting or bleeding disorders
  • Allergic or intolerant to any ingredient found in the study products
  • Participant in a concomitant trial that conflicts with this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520065

Locations
United States, Indiana
Provident Clinical Research and Consulting, Inc.
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Abbott Nutrition
Investigators
Principal Investigator: Kevin C. Maki, PhD Provident Clinical Research and Consulting, Inc.
  More Information

No publications provided by Abbott Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00520065     History of Changes
Other Study ID Numbers: BK06
Study First Received: August 21, 2007
Last Updated: July 2, 2008
Health Authority: United States: Institutional Review Board

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 17, 2013