Clinical trial NCT00520065: Comparison of Nutritional Products for People With Type 2 Diabetes
Official title: Comparison of Nutritional Products for People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Positive area under the curve (AUC) for plasma glucose and mean glucose level
timeFrame: 240 minutes
Secondary outcomes:
measure: Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Provident Clinical Research and Consulting, Inc.
state: Indiana
Study officials:
affiliation: Provident Clinical Research and Consulting, Inc.
name: Kevin C. Maki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.