search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
standard enteral feeding product
Diabetes specific feeding product
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Segal Institute for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

#1

#2

Arm Description

Diabetes specific enteral feeding product

Standard enteral feeding product

Outcomes

Primary Outcome Measures

mean glucose level

Secondary Outcome Measures

fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin

Full Information

First Posted
October 12, 2007
Last Updated
September 22, 2008
Sponsor
Abbott Nutrition
search

1. Study Identification

Unique Protocol Identification Number
NCT00544206
Brief Title
Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
Official Title
Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
#1
Arm Type
Experimental
Arm Description
Diabetes specific enteral feeding product
Arm Title
#2
Arm Type
Active Comparator
Arm Description
Standard enteral feeding product
Intervention Type
Other
Intervention Name(s)
standard enteral feeding product
Intervention Description
16 hrs daily x 5 days
Intervention Type
Other
Intervention Name(s)
Diabetes specific feeding product
Intervention Description
16 hrs daily for 5 days
Primary Outcome Measure Information:
Title
mean glucose level
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Sacks, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Segal Institute for Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20470226
Citation
Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25. doi: 10.1089/dia.2009.0185.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs