Glycemic Response to Two Enteral Formulas 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 two interventions on two separate study days, 1 week apart.

Official Title
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Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

Conditions
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Diabetes

Intervention / Treatment
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* Other: Enteral Nutrition Formula


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/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset) Hemoglobin A1C less than 9.0% Fasting blood glucose less than 180 mg Exclusion Criteria: Abnormal thyroid function Creatinine >2.0 mg/dL Potassium <3.5 mEq/L Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities Patients currently on any anti-coagulant medication 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, fish oil 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.

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: Enteral Nutrition Formula 1<br>Enteral Nutrition Formula | Other: Enteral Nutrition Formula<br> <br> |
| Active Comparator: Enteral Nutrition Formula 2<br>Enteral Nutrition Formula | Other: Enteral Nutrition Formula<br> <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 (Ins30/(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 |