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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Adult enteral formula

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Carolyn Alish, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Protocare Trials, Chicago Center for Clinical Research

Chicago, Illinois, United States

Site Status

Medical University of South Carolina

Charleston, North Carolina, United States