Diabetes Mellitus, Type 2
Conditions
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 usual diet.
Interventions
OTHERNutritional Formula
nutritional shake daily
OTHERUsual diet
usual dietary habits
OTHERDiabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.
nutritional shake, diabetes specific cereal and diabetes snack bar daily
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. type 2 diabetes 2. HbA1c \>6.5% and \<11.0% 3. male/non-pregnant, non-lactating female, at least 6 months postpartum 4. if female of childbearing potential, practicing method of birth control 5. Body Mass Index \> 18.5 kg/m2 and \< 43.0 kg/m2. 6. weight stable for past two months 7. if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months
Exclusion criteria
1. uses injected medications (e.g., insulin, exenatide) for glucose control. 2. history of diabetic ketoacidosis 3. current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks 4. active malignancy 5. 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. 6. end stage organ failure 7. active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes. 8. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 9. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose. 10. symptomatic in response to blood collection prior to enrollment into this study. 11. clotting or bleeding disorders. 12. non-typical eating pattern 13. is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week. 14. engages in strenuous exercise five or more times per week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average daily blood glucose level | 11 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables | 11 days |
Countries
United States
Outcome results
None listed