Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
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
1 other identifier
interventional
54
1 country
2
Brief Summary
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedOctober 15, 2007
October 1, 2007
October 5, 2007
October 12, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Adjusted area under the curve (adj-AUC) of glucose response
0-240 minutes
Secondary Outcomes (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
0 - 240 minutes
Interventions
Eligibility Criteria
You may qualify if:
- signed and dated informed consent
- years of age
- history of type 2 diabetes
- males and non-pregnant, non-lactating females
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (2)
Protocare Trials, Chicago Center for Clinical Research
Chicago, Illinois, 60610, United States
Medical University of South Carolina
Charleston, North Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carolyn Alish, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 8, 2007
Study Start
August 1, 2002
Last Updated
October 15, 2007
Record last verified: 2007-10