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Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
This study has been completed.
Sponsored by: Abbott Nutrition
Information provided by: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00540488
  Purpose

To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.


Condition Intervention Phase
Diabetes Mellitus Type 2
 Other: Adult enteral formula
 Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Dextrose
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment
Official Title: Randomized, Double Blind, Three Way Crossover Comparison of Glucose and Insulin Responses During a Meal Glucose Tolerance Test in Subjects With Type 2 Diabetes Consuming Disease-Specific Versus Standard Nutritional Formula

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Adjusted area under the curve (adj-AUC) of glucose response [ Time Frame: 0-240 minutes ]

Secondary Outcome Measures:
  • Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance [ Time Frame: 0 - 240 minutes ]

Enrollment: 54
Study Start Date: August 2002
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • signed and dated informed consent
  • 18-75 years of age
  • history of type 2 diabetes
  • males and non-pregnant, non-lactating females

Exclusion Criteria:

  • subject uses insulin for glucose control
  • significant cardiovascular event <12 weeks prior to study entry
  • active malignancies
  • history of end stage renal disease
  • history of organ transplant
  • current hepatic disease
  • intervention for HIB
  • takes niacin
  • history of gastroparesis
  • active disease that may interfere with nutrient intake
  • allergy or intolerance to ingredients in the study products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540488

Locations
United States, Illinois
Protocare Trials, Chicago Center for Clinical Research
Chicago, Illinois, United States, 60610
United States, North Carolina
Medical University of South Carolina
Charleston, North Carolina, United States, 29425
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Carolyn Alish, PhD Abbott Nutrition
  More Information

Study ID Numbers: SRDB09
Study First Received: October 5, 2007
Last Updated: October 12, 2007
ClinicalTrials.gov Identifier: NCT00540488  
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on January 14, 2009



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