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

Study Overview
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Brief Summary
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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

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: standard enteral feeding product
* Other: Diabetes specific feeding product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: #1<br>Diabetes specific enteral feeding product | Other: Diabetes specific feeding product<br>* 16 hrs daily for 5 days<br>|
| Active Comparator: #2<br>Standard enteral feeding product | Other: standard enteral feeding product<br>* 16 hrs daily x 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean glucose level |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin |  | 24 hours |