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

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00540488
First received: October 5, 2007
Last updated: October 12, 2007
Last verified: October 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on October 22, 2014