Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This will be a randomized, cross-over design. Subjects will be randomized to one of six interventions on six separate study days, 1 week apart.

Official Title
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Plasma Glucose and Insulin Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

Conditions
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Diabetes

Intervention / Treatment
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* Other: Meal replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-75 yrs Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset) Hemoglobin A1C less than 9.0% Fasting blood glucose less than 180 mg Hematocrit levels within normal limits 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
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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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meal replacement A<br> | Other: Meal replacement<br>* The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.<br>|
| Active Comparator: Meal replacement B<br> | Other: Meal replacement<br>* The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.<br>|
| Active Comparator: Meal replacement C<br> | Other: Meal replacement<br>* The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.<br>|
| Active Comparator: Meal replacement D<br> | Other: Meal replacement<br>* The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.<br>|
| Active Comparator: Meal replacement E<br> | Other: Meal replacement<br>* The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.<br>|
| Active Comparator: Meal replacement F<br> | Other: Meal replacement<br>* The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.<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 (AUC 0-240) |  | 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 | 
| AUC (0-30min) for insulin |  | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |