Back to resultsGlucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Adult enteral formula
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility 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
Sites / Locations
- Protocare Trials, Chicago Center for Clinical Research
- Medical University of South Carolina
Outcomes
Primary Outcome Measures
Adjusted area under the curve (adj-AUC) of glucose response
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00540488
Brief Title
Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Nutrition
4. Oversight
5. Study Description
Brief Summary
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Adult enteral formula
Primary Outcome Measure Information:
Title
Adjusted area under the curve (adj-AUC) of glucose response
Time Frame
0-240 minutes
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Alish, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Protocare Trials, Chicago Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
North Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
We'll reach out to this number within 24 hrs