Comparison of Nutritional Products for People With Type 2 Diabetes

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Comparison of Nutritional Products for People With Type 2 Diabetes

This study is currently recruiting participants.
Verified by Abbott Nutrition, November 2008
Sponsored by: Abbott Nutrition

Information provided by: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00797069

Purpose
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

MedlinePlus related topics: Diabetes
U.S. FDA Resources
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

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. [ Time Frame: Three crossover periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. [ Time Frame: Three crossover periods ] [ Designated as safety issue: No ]

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

Eligibility
Ages Eligible for Study:18 Years to 75 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria
Inclusion Criteria:

Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
Subject is between 18 and 75 years of age, inclusive.
Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
If female is of childbearing potential, is practicing a method of birth control.
Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.
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:

Subject uses exogenous insulin for glucose control.
Subject states that he/she has type 1 diabetes.
Subject states that he/she has a history of diabetic ketoacidosis.
Subject takes an alpha-glucosidase inhibitor.
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.
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).
Subject states that he/she has had a significant cardiovascular event ¡Ü six months prior to screening visit; or stated history of congestive heart failure.
Subject states that he/she has end stage organ failure or is status post organ transplant.
Subject states that he/she has a history of renal disease.
Subject states that he/she has current hepatic disease.
Subject states that he/she has a history of severe gastroparesis.
Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
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.
Subject states that he/she has clotting or bleeding disorders.
Subject is known to be allergic or intolerant to any ingredient found in the study products.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797069

Contacts
Contact: Bobbie Swearengin, RN 614 624 7182 bobbie.swearengin@abbott.com

Locations
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

Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Jennifer Williams, MS Abbott Nutrition

Responsible Party:Abbott Nutrition ( Bobbie Swearengin, Director Clinical Research )
Study ID Numbers:BK20
First Received:November 23, 2008
Last Updated:November 24, 2008
ClinicalTrials.gov Identifier:NCT00797069 [history]
Health Authority:Spain: Ethics Committee

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders