Comparison of Nutritional Products for People With Type 2 Diabetes

July 2, 2008 updated by: Abbott Nutrition

Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.

Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

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

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Provident Clinical Research and Consulting, Inc.

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated informed consent form
  • Type 2 diabetes
  • 18 to 75 years of age
  • Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
  • If female is of childbearing potential, is practicing birth control
  • BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
  • Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit

Exclusion Criteria:

  • Uses exogenous insulin for glucose control
  • Type 1 diabetes
  • History of diabetic ketoacidosis
  • Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
  • Active malignancy
  • Significant cardiovascular event less than 12 weeks prior to study entry
  • End stage organ failure or is status post organ transplant
  • Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
  • Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
  • Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
  • Fainted or experienced other adverse reactions in response to blood collection prior to this study
  • Has clotting or bleeding disorders
  • Allergic or intolerant to any ingredient found in the study products
  • Participant in a concomitant trial that conflicts with this study

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: #1
Diabetes specific enteral product
Other: Diabetes specific enteral product
Meal Glucose tolerance test
Active Comparator: #2
Standard enteral feeding
Other: enteral nutritional formula
Meal glucose tolerance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive area under the curve (AUC) for plasma glucose and mean glucose level
Time Frame: 240 minutes
240 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration
Time Frame: 240 minutes
240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Principal Investigator: Kevin C. Maki, PhD, Provident Clinical Research and Consulting, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 23, 2007

Study Record Updates

Last Update Posted (Estimate)

July 4, 2008

Last Update Submitted That Met QC Criteria

July 2, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK06

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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