Comparison of Nutritional Products for People With Type 2 Diabetes

Abbott

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Other: Diabetes specific enteral product

Other: enteral nutritional formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT00520065

BK06

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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