Comparison of Nutritional Products for People With Type 2 Diabetes

Completed · Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00520065

Run by

Abbott Nutrition

People needed

33

Starts

2007-08-01

Expected to finish

2007-11-01

Last updated by the study team

2008-07-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Provident Clinical Research and Consulting, Inc. — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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