Comparison of Nutritional Products for People With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Comparison of Nutritional Products for People With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520065
• Other study ID #: BK06
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2007
• Last updated: July 2, 2008
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: August 2007
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• enteral nutritional formula
Meal glucose tolerance test
• Diabetes specific enteral product
Meal Glucose tolerance test

Locations

Country	Name	City	State
United States	Provident Clinical Research and Consulting, Inc.	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive area under the curve (AUC) for plasma glucose and mean glucose level		240 minutes	No
Secondary	Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration		240 minutes	No