Comparison of Nutritional Products for People With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Diabetes specific enteral product; Other: enteral nutritional formula

• Registration Number: NCT00520065
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-23
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Last Update Submitted: 2008-07-02
• Last Update Posted: 2008-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
#1	Diabetes specific enteral product	Diabetes specific enteral product
#2	enteral nutritional formula	Standard enteral feeding

Primary Outcome Measures

Name	Time	Method
Positive area under the curve (AUC) for plasma glucose and mean glucose level	240 minutes

Secondary Outcome Measures

Name	Time	Method
Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration	240 minutes

Trial Locations

Locations (1)

Provident Clinical Research and Consulting, Inc.; 🇺🇸 Bloomington, Indiana, United States