Text Size

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

August 21, 2007
July 2, 2008
August 2007
October 2007   (final data collection date for primary outcome measure)
Positive area under the curve (AUC) for plasma glucose and mean glucose level [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]
Positive area under the curve (AUC) for plasma glucose and mean glucose level [ Time Frame: 240 minutes ]
Complete list of historical versions of study NCT00520065 on ClinicalTrials.gov Archive Site
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 ]
Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration [ Time Frame: 240 minutes ]
Not Provided
Not Provided
 
Comparison of Nutritional Products for People With Type 2 Diabetes
Comparison of Nutritional Products for People With Type 2 Diabetes

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Other: enteral nutritional formula
    Meal glucose tolerance test
  • Other: Diabetes specific enteral product
    Meal Glucose tolerance test
  • Experimental: #1
    Diabetes specific enteral product
    Intervention: Other: Diabetes specific enteral product
  • Active Comparator: #2
    Standard enteral feeding
    Intervention: Other: enteral nutritional formula
Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
November 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00520065
BK06
No
Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
Abbott Nutrition
Not Provided
Principal Investigator: Kevin C. Maki, PhD Provident Clinical Research and Consulting, Inc.
Abbott Nutrition
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP