Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
Completed · Phase 2
Conditions studied: Type 2 Diabetes Mellitus
In brief
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
Key facts
- Study ID
- NCT00544206
- Run by
- Abbott Nutrition
- People needed
- 11
- Starts
- 2007-10-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2008-09-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
Where it is running
- Segal Institute for Clinical Research — Miami, Florida, United States
Full record on ClinicalTrials.gov
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