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CompletedNCT00544206Updated Sep 23, 2008

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

A Phase 2 interventional study of standard enteral feeding product and Diabetes specific feeding product in Type 2 Diabetes Mellitus, sponsored by Abbott Nutrition. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-09-23.

Sponsored by Abbott Nutrition · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 11 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    #1

    Diabetes specific enteral feeding product

    Other: Diabetes specific feeding product

  • Active comparator
    #2

    Standard enteral feeding product

    Other: standard enteral feeding product

Interventions

  • Otherstandard enteral feeding product

    16 hrs daily x 5 days

  • OtherDiabetes specific feeding product

    16 hrs daily for 5 days

06

What researchers measure

Primary outcomes

  1. mean glucose level

    Time frame: 24 hours

Secondary outcomes

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

    Time frame: 24 hours

07

Study locations

1 site
  • Segal Institute for Clinical Research
    Miami, Florida 33161, United States
08

References and documents

Publications

  • 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. PubMed 20470226 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00544206
Lead sponsor
Abbott Nutrition
First posted
Oct 16, 2007
Start date
Oct 2007
Primary completion
Aug 2008
Completion
Sep 2008
Last update
Sep 23, 2008

Study contacts

Gordon Sacks, PhD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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