Glycemic Response in Persons With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

Official Title
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Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Oral Nutrition Supplement


Participation Criteria
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Eligibility Criteria
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Subject inclusion criteria All subjects must comply with all the following inclusion criteria: Age 20-75 years Type 2 diabetes controlled with diet or diet and metformin (Glucophage) Hemoglobin A1C less than 9.0% Fasting blood glucose less than 180 mg Hematocrit levels within normal limits Having obtained his/her informed consent Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study. Abnormal thyroid function Creatinine >2.0 mg/dl Potassium <3.5 mEq/l Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting Currently unstable diabetes or under treatment for cancer, heart disease, renal disease Unable to give informed consent or follow instructions Current insulin therapy or insulin therapy within the past month Patient who are pregnant Allergies to milk, soy or any component of the test product Patient who in the investigators assessment cannot be expected to comply with treatment Currently participating or having participated in another clinical trial Patients with anemia

Ages Eligible for Study
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Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Nutrition Supplement A<br>Product containing calories from carbohydrate, protein, and fat | Other: Oral Nutrition Supplement<br>* Product intake of oral nutrition supplement provided<br>|
| Active Comparator: Oral Nutrition Supplement B<br>Product containing calories from carbohydrate, protein, and fat | Other: Oral Nutrition Supplement<br>* Product intake of oral nutrition supplement provided<br>|
| Active Comparator: Oral Nutrition Supplement C<br>Product containing calories from carbohydrate, protein, and fat | Other: Oral Nutrition Supplement<br>* Product intake of oral nutrition supplement provided<br>|
| Active Comparator: Oral Nutrition Supplement D<br>Product containing calories from carbohydrate, protein, and fat | Other: Oral Nutrition Supplement<br>* Product intake of oral nutrition supplement provided<br>|
| Active Comparator: Oral Nutrition Supplement E<br>Product containing calories from carbohydrate, protein, and fat | Other: Oral Nutrition Supplement<br>* Product intake of oral nutrition supplement provided<br>|
| Active Comparator: Oral Nutrition Supplement F<br>Product containing calories from carbohydrate, protein, and fat | Other: Oral Nutrition Supplement<br>* Product intake of oral nutrition supplement provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the blood glucose curve (ACU 0-240 minutes) |  | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin curves (AUC 0-240) |  | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes | 
| Insulinogenic index [Change in Ins30/Change in Glu30] |  | [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes] |