Comparison of Nutritional Products for People With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00520065
First received: August 21, 2007
Last updated: July 2, 2008
Last verified: August 2007
  Purpose

Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.

Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Other: enteral nutritional formula
Other: Diabetes specific enteral product
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nutritional Products for People With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Positive area under the curve (AUC) for plasma glucose and mean glucose level [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: #1
Diabetes specific enteral product
Other: Diabetes specific enteral product
Meal Glucose tolerance test
Active Comparator: #2
Standard enteral feeding
Other: enteral nutritional formula
Meal glucose tolerance test

  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 form
  • Type 2 diabetes
  • 18 to 75 years of age
  • Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
  • If female is of childbearing potential, is practicing birth control
  • BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
  • Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit

Exclusion Criteria:

  • Uses exogenous insulin for glucose control
  • Type 1 diabetes
  • History of diabetic ketoacidosis
  • Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
  • Active malignancy
  • Significant cardiovascular event less than 12 weeks prior to study entry
  • End stage organ failure or is status post organ transplant
  • Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
  • Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
  • Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
  • Fainted or experienced other adverse reactions in response to blood collection prior to this study
  • Has clotting or bleeding disorders
  • Allergic or intolerant to any ingredient found in the study products
  • Participant in a concomitant trial that conflicts with this study
  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: NCT00520065

Locations
United States, Indiana
Provident Clinical Research and Consulting, Inc.
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Abbott Nutrition
Investigators
Principal Investigator: Kevin C. Maki, PhD Provident Clinical Research and Consulting, Inc.
  More Information

No publications provided by Abbott Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00520065     History of Changes
Other Study ID Numbers: BK06
Study First Received: August 21, 2007
Last Updated: July 2, 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 July 24, 2014