Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
1 other identifier
interventional
11
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Oct 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 12, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedSeptember 23, 2008
September 1, 2008
10 months
October 12, 2007
September 22, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
mean glucose level
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
24 hours
Study Arms (2)
#1
EXPERIMENTALDiabetes specific enteral feeding product
#2
ACTIVE COMPARATORStandard enteral feeding product
Interventions
Eligibility Criteria
You may qualify if:
- signed and dated informed consent
- diagnosis of type 2 diabetes
- HbA1c between 7.0 and 9.0%
- years of age
- currently receiving a standard enteral product
- anticipated duration on tube feeding at least one month
- % 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
Segal Institute for Clinical Research
Miami, Florida, 33161, United States
Related Publications (1)
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.
PMID: 20470226DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon Sacks, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2007
First Posted
October 16, 2007
Study Start
October 1, 2007
Primary Completion
August 1, 2008
Study Completion
September 1, 2008
Last Updated
September 23, 2008
Record last verified: 2008-09