Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.

Key facts

Study ID

NCT00753181

Run by

Abbott Nutrition

People needed

60

Starts

2008-08-01

Expected to finish

2009-03-01

Last updated by the study team

2009-04-27

Who can join

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

You may qualify if…

• type 2 diabetes
• HbA1c >6.5% and <11.0%
• male/non-pregnant, non-lactating female, at least 6 months postpartum
• if female of childbearing potential, practicing method of birth control
• Body Mass Index > 18.5 kg/m2 and < 43.0 kg/m2.
• weight stable for past two months
• if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months

You may not qualify if…

• uses injected medications (e.g., insulin, exenatide) for glucose control.
• history of diabetic ketoacidosis
• current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
• active malignancy
• states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
• end stage organ failure
• active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
• chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
• use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
• symptomatic in response to blood collection prior to enrollment into this study.
• clotting or bleeding disorders.
• non-typical eating pattern
• is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
• engages in strenuous exercise five or more times per week.

Where it is running

• Provident Clinical Research — Bloomington, Indiana, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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