Comparison of Nutritional Products for People With Type 2 Diabetes
NCT ID: NCT00520065
Last Updated: 2008-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2007-08-31
2007-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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#1
Diabetes specific enteral product
Diabetes specific enteral product
Meal Glucose tolerance test
#2
Standard enteral feeding
enteral nutritional formula
Meal glucose tolerance test
Interventions
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enteral nutritional formula
Meal glucose tolerance test
Diabetes specific enteral product
Meal Glucose tolerance test
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
Principal Investigators
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Kevin C. Maki, PhD
Role: PRINCIPAL_INVESTIGATOR
Provident Clinical Research and Consulting, Inc.
Locations
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Provident Clinical Research and Consulting, Inc.
Bloomington, Indiana, United States
Countries
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References
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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. doi: 10.1089/dia.2009.0185.
Other Identifiers
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BK06
Identifier Type: -
Identifier Source: org_study_id