Status:
COMPLETED
Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes
Lead Sponsor:
Abbott Nutrition
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00753181
Start Date
August 1 2008
End Date
March 1 2009
Last Update
April 27 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Provident Clinical Research
Bloomington, Indiana, United States, 47403
2
Radiant Research
Cincinnati, Ohio, United States, 45242