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NCT00540488 Clinical Trial

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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00540488
Other study ID # SRDB09
Secondary ID
Status Completed
Phase Phase 3
First received October 5, 2007
Last updated October 12, 2007
Start date August 2002

Study information
Verified date October 2007
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Adult enteral formula

Locations
Country Name City State
United States Medical University of South Carolina Charleston North Carolina
United States Protocare Trials, Chicago Center for Clinical Research Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adjusted area under the curve (adj-AUC) of glucose response 0-240 minutes
Secondary 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
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