Evaluation of a Nutritional Product for People With Type 2 Diabetes
NCT ID: NCT01850810
Last Updated: 2015-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2013-05-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Experimental Study Product
1 serving of a nutritional product for people with diabetes.
Experimental Study Product
Control Study Product
1 serving of control beverage.
Control Study Product
Interventions
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Experimental Study Product
Control Study Product
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Devitt-Maicher, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Radiant Research
Chicago, Illinois, United States
Radiant Research
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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BL17
Identifier Type: -
Identifier Source: org_study_id
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