Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540488
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : October 15, 2007
Information provided by:
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Other: Adult enteral formula Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2002

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00540488

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
Study Chair: Carolyn Alish, PhD Abbott Nutrition Identifier: NCT00540488     History of Changes
Other Study ID Numbers: SRDB09
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: October 15, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases