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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014