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

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00544206
First received: October 12, 2007
Last updated: September 22, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Other: standard enteral feeding product
Other: Diabetes specific feeding product
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • mean glucose level [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Abbott Nutrition

Additional 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
Study First Received: October 12, 2007
Last Updated: September 22, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 17, 2012