We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Comparison of Nutritional Products for People With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00520065
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : July 4, 2008
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: enteral nutritional formula Other: Diabetes specific enteral product Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nutritional Products for People With Type 2 Diabetes
Study Start Date : August 2007
Primary Completion Date : October 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Positive area under the curve (AUC) for plasma glucose and mean glucose level [ Time Frame: 240 minutes ]

Secondary Outcome Measures :
  1. Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration [ Time Frame: 240 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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): NCT00520065

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

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
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: July 4, 2008
Last Verified: August 2007

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