Glycemic Response in Adults With Diabetes

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

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

Official Title
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Glucose and Insulin Response in Adults With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Balance oral nutritional drink - control
* Other: Balance oral nutritional drink - test


Participation Criteria
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Eligibility Criteria
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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/dl 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 Patients with anemia 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 Patients with anemia Currently participating in another clinical trial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Active Comparator: Oral Nutrition Supplement Control<br>The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition. | Other: Balance oral nutritional drink - control<br>* Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.<br>|
| Active Comparator: Active Comparator: Oral Nutrition Supplement Test<br>The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes. | Other: Balance oral nutritional drink - test<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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial glycemic markers | Area under the blood glucose curve (AUC 0-240 minutes) | [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes] | 

Secondary Outcome Measures

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