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

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ClinicalTrials.gov Identifier: NCT00544206
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : September 23, 2008
Sponsor:
Information provided by:
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: standard enteral feeding product Other: Diabetes specific feeding product Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
Study Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: #1
Diabetes specific enteral feeding product
Other: Diabetes specific feeding product
16 hrs daily for 5 days
Active Comparator: #2
Standard enteral feeding product
Other: standard enteral feeding product
16 hrs daily x 5 days



Primary Outcome Measures :
  1. mean glucose level [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544206


Locations
United States, Florida
Segal Institute for Clinical Research
Miami, Florida, United States, 33161
Sponsors and Collaborators
Abbott Nutrition
Investigators
Principal Investigator: Gordon Sacks, PhD University of Wisconsin, Madison

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00544206     History of Changes
Other Study ID Numbers: BK07
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: September 23, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases