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Sponsored by: |
Abbott Nutrition |
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Information provided by: | Abbott Nutrition |
ClinicalTrials.gov Identifier: | NCT00797069 |
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Other: standard nutritional product (medical food) Other: nutritional product for diabetes (medical food) Other: diabetes specific experimental nutritional product (medical food) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
Official Title: | Comparison of Nutritional Products for People With Type 2 Diabetes |
Estimated Enrollment: | 54 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
standard nutritional product: Active Comparator
Standard nutritional product not specific for diabetes
|
Other: standard nutritional product (medical food)
once during crossover
|
diabetes specific product: Active Comparator
Diabetes specific nutritional product
|
Other: nutritional product for diabetes (medical food)
once during crossover
|
Experimental diabetes specific product: Experimental
Diabetes specific experimental nutritional product
|
Other: diabetes specific experimental nutritional product (medical food)
once during crossover
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bobbie Swearengin, RN | 614 624 7182 | bobbie.swearengin@abbott.com |
Spain | |
Hospital Universitario Miguel Servet | Not yet recruiting |
Zaragoza, Spain, 50009 | |
Principal Investigator: Alejandro Sanz Paris, PhD | |
Hospital Clinico San Carlos | Recruiting |
Madrid, Spain, 28040 | |
Principal Investigator: Maria P Matia Martin, MD | |
Hospital Universitario Virgen de la Victoria | Recruiting |
Malaga, Spain, 29010 | |
Principal Investigator: Jose Manuel Garcia Almeida, MD |
Study Chair: | Jennifer Williams, MS | Abbott Nutrition |
Responsible Party: | Abbott Nutrition ( Bobbie Swearengin, Director Clinical Research ) |
Study ID Numbers: | BK20 |
Study First Received: | November 23, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797069 |
Health Authority: | Spain: Ethics Committee |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |