- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00540488
Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
October 12, 2007 updated by: Abbott Nutrition
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
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60610
- Protocare Trials, Chicago Center for Clinical Research
-
-
North Carolina
-
Charleston, North Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adjusted area under the curve (adj-AUC) of glucose response
Time Frame: 0-240 minutes
|
0-240 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
0 - 240 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Carolyn Alish, PhD, Abbott Nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Study Registration Dates
First Submitted
October 5, 2007
First Submitted That Met QC Criteria
October 5, 2007
First Posted (Estimate)
October 8, 2007
Study Record Updates
Last Update Posted (Estimate)
October 15, 2007
Last Update Submitted That Met QC Criteria
October 12, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRDB09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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