Comparison of Nutritional Products for People With Type 2 Diabetes
NCT ID: NCT00797069
Last Updated: 2010-07-30
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
PHASE3
58 participants
INTERVENTIONAL
2008-11-30
2009-07-31
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
TREATMENT
QUADRUPLE
Study Groups
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standard nutritional product
Standard nutritional product not specific for diabetes
standard nutritional product (medical food)
once during crossover
diabetes specific product
Diabetes specific nutritional product
nutritional product for diabetes (medical food)
once during crossover
Experimental diabetes specific product
Diabetes specific experimental nutritional product
diabetes specific experimental nutritional product (medical food)
once during crossover
Interventions
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standard nutritional product (medical food)
once during crossover
nutritional product for diabetes (medical food)
once during crossover
diabetes specific experimental nutritional product (medical food)
once during crossover
Eligibility Criteria
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Inclusion Criteria
2. Subject is between 18 and 75 years of age, inclusive.
3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
4. If female is of childbearing potential, is practicing a method of birth control.
5. Subject's BMI is \> 18.5 kg/m2 and \< 35 kg/m2.
6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
Exclusion Criteria
2. Subject states that he/she has type 1 diabetes.
3. Subject states that he/she has a history of diabetic ketoacidosis.
4. Subject takes an alpha-glucosidase inhibitor.
5. Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
6. Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
7. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
8. Subject states that he/she has end stage organ failure or is status post organ transplant.
9. Subject states that he/she has a history of renal disease.
10. Subject states that he/she has current hepatic disease.
11. Subject states that he/she has a history of severe gastroparesis.
12. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
13. Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
14. Subject states that he/she has clotting or bleeding disorders.
15. Subject is known to be allergic or intolerant to any ingredient found in the study products.
18 Years
75 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
Principal Investigators
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Jennifer Williams, MS
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Other Identifiers
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BK20
Identifier Type: -
Identifier Source: org_study_id