Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.

Official Title
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Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Nutritional Formula
* Other: Usual diet
* Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes HbA1c >6.5% and <11.0% male/non-pregnant, non-lactating female, at least 6 months postpartum if female of childbearing potential, practicing method of birth control Body Mass Index > 18.5 kg/m2 and < 43.0 kg/m2. weight stable for past two months if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months Exclusion Criteria: uses injected medications (e.g., insulin, exenatide) for glucose control. history of diabetic ketoacidosis current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks active malignancy states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months. end stage organ failure active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose. symptomatic in response to blood collection prior to enrollment into this study. clotting or bleeding disorders. non-typical eating pattern is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week. engages in strenuous exercise five or more times per week.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br>Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake | Other: Nutritional Formula<br>* nutritional shake daily<br>|
| Active Comparator: A2<br>Usual diet | Other: Usual diet<br>* usual dietary habits<br>|
| Experimental: A3<br>Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars. | Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.<br>* nutritional shake, diabetes specific cereal and diabetes snack bar daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily blood glucose level |  | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables |  | 11 days |