Glycemic Response in Persons With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This will be a randomized crossover design with nutrition supplement interventions.

Detailed Description
-----------------
This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.

Official Title
-----------------
Plasma Glucose and Insulin Response in Persons With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Balanced Nutritional Drink
* Other: Diabetes Specific, Balanced Nutritional Drink (DMA)
* Other: Diabetes Specific, Balanced Nutritional Drink DMB


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Exclusion Criteria: 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
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 three interventions on three separate study days, one week apart.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balanced Nutritional Drink<br>The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition. | Other: Balanced Nutritional Drink<br>* Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.<br>|
| Active Comparator: Balanced Nutritional Drink - DMA<br>The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes. | Other: Diabetes Specific, Balanced Nutritional Drink (DMA)<br>* Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.<br>|
| Active Comparator: Balanced Nutritional Drink - DMB<br>The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes. | Other: Diabetes Specific, Balanced Nutritional Drink DMB<br>* Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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