Comparison of Nutritional Products for People With Type 2 Diabetes

Study Overview
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Brief Summary
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Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: standard nutritional product (medical food)
* Other: nutritional product for diabetes (medical food)
* Other: diabetes specific experimental nutritional product (medical food)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months). Subject is between 18 and 75 years of age, inclusive. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. If female is of childbearing potential, is practicing a method of birth control. Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit. Exclusion Criteria: Subject uses exogenous insulin for glucose control. Subject states that he/she has type 1 diabetes. Subject states that he/she has a history of diabetic ketoacidosis. Subject takes an alpha-glucosidase inhibitor. Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix). Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. Subject states that he/she has end stage organ failure or is status post organ transplant. Subject states that he/she has a history of renal disease. Subject states that he/she has current hepatic disease. Subject states that he/she has a history of severe gastroparesis. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose. Subject states that he/she has clotting or bleeding disorders. Subject is known to be allergic or intolerant to any ingredient found in the study products.

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 |
| --- | --- |
| Active Comparator: standard nutritional product<br>Standard nutritional product not specific for diabetes | Other: standard nutritional product (medical food)<br>* once during crossover<br>|
| Active Comparator: diabetes specific product<br>Diabetes specific nutritional product | Other: nutritional product for diabetes (medical food)<br>* once during crossover<br>|
| Experimental: Experimental diabetes specific product<br>Diabetes specific experimental nutritional product | Other: diabetes specific experimental nutritional product (medical food)<br>* once during crossover<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. |  | Three crossover periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. |  | Three crossover periods |