Evaluation of a Nutritional Product for People With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:2/8/2015
Start Date:May 2013
End Date:July 2013
Contact:Kristen DeLuca, MS, RD, LD
Email:kristen.deluca@abbott.com
Phone:614-624-5455

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Evaluation of a Nutritional Product for People With Type 2 Diabetes (T2DM)

The objective of this trial is to evaluate a nutritional product for people with Diabetes.


Inclusion Criteria:

- Subjects will be eligible for the study if they meet all of the following inclusion
criteria:

1. Diagnosis of Type 2 Diabetes.

2. Age between 18 and 75 years.

3. HbA1c > 6.0 but ≤ 8.5

4. If female and of childbearing potential , subject is non-pregnant, non-
lactating, at least 6 weeks postpartum and agrees to practice birth control
throughout study duration.

5. BMI is > 18.5 kg/m2 and < 40.0 kg/m2.

6. Chronic medication dosage must be stable for at least two months prior to
Screening Visit.

7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

- Subjects will be excluded from the study if they meet any of the following criteria:

1. Use of exogenous insulin or GLP-1 agonists for glucose control.

2. Diagnosis of Type 1 diabetes.

3. History of diabetic ketoacidosis.

4. Current infection (requiring medication or hospitalization), has received
corticosteroid treatment in the last 3 months, or has had surgery or received
antibiotics in the last 3 weeks.

5. Active malignancy.

6. Significant cardiovascular event < 12 weeks prior to study entry.

7. End stage organ failure or status post organ transplant.

8. Active metabolic, hepatic, or gastrointestinal disease.

9. Chronic, contagious, infectious disease.

10. Currently taking herbals, dietary supplements, or medications (other than
antihyperglycemic medications) that could profoundly affect blood glucose.

11. History of fainting or other adverse reactions in response to blood collection.

12. Clotting or bleeding disorders.

13. Allergy or intolerance to study product ingredient.
We found this trial at
2
sites
Chicago, Illinois 60654
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Chicago, IL
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Cincinnati, Ohio 45249
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Cincinnati, OH
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