Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes

September 22, 2008 updated by: Abbott Nutrition
To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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
    • Florida
      • Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research

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
  • diagnosis of type 2 diabetes
  • HbA1c between 7.0 and 9.0%
  • 18 - 75 years of age
  • currently receiving a standard enteral product
  • anticipated duration on tube feeding at least one month
  • 100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
  • anticipated life expectancy is more than or equal to 6 months
  • free of infections
  • no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose

Exclusion Criteria:

  • composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
  • composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
  • significant cardiovascular event less than or equal to 2 weeks prior to study entry
  • major surgery less than or equal to 2 weeks prior to study entry
  • pre-planned surgery during the study period
  • active malignancy, including melanoma and excluding cutaneous malignancies
  • severe dementia
  • known allergies to medical grade adhesives and/or skin disinfectants
  • taking octreotide
  • chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
  • participation in a concomitant trial

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: #1
Diabetes specific enteral feeding product
Other: Diabetes specific feeding product
16 hrs daily for 5 days
Active Comparator: #2
Standard enteral feeding product
Other: standard enteral feeding product
16 hrs daily x 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean glucose level
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Abbott Nutrition

Investigators

  • Principal Investigator: Gordon Sacks, PhD, University of Wisconsin, Madison

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

October 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 12, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2008

Last Update Submitted That Met QC Criteria

September 22, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK07

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.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Diabetes specific feeding product

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe