Comparison of Nutritional Products for People With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Nutritional Products for People With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: enteral nutritional formula
* Other: Diabetes specific enteral product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: #1<br>Diabetes specific enteral product | Other: Diabetes specific enteral product<br>* Meal Glucose tolerance test<br>|
| Active Comparator: #2<br>Standard enteral feeding | Other: enteral nutritional formula<br>* Meal glucose tolerance test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive area under the curve (AUC) for plasma glucose and mean glucose level |  | 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration |  | 240 minutes |