Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
NCT ID: NCT00544206
Last Updated: 2008-09-23
Study Results
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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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2007-10-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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#1
Diabetes specific enteral feeding product
Diabetes specific feeding product
16 hrs daily for 5 days
#2
Standard enteral feeding product
standard enteral feeding product
16 hrs daily x 5 days
Interventions
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standard enteral feeding product
16 hrs daily x 5 days
Diabetes specific feeding product
16 hrs daily for 5 days
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
Principal Investigators
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Gordon Sacks, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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Segal Institute for Clinical Research
Miami, Florida, United States
Countries
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References
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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.
Other Identifiers
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BK07
Identifier Type: -
Identifier Source: org_study_id