Diabetes Mellitus, Type 2
Conditions
Brief summary
This will be a randomized crossover design with nutrition supplement interventions.
Detailed description
This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
Interventions
OTHERBalanced Nutritional Drink
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
OTHERDiabetes Specific, Balanced Nutritional Drink (DMA)
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.
OTHERDiabetes Specific, Balanced Nutritional Drink DMB
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.
Intervention model description
This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 20-75 years * Type 2 diabetes controlled with diet or diet and metformin (Glucophage) * Hemoglobin A1C less than 9.0% * Fasting blood glucose less than 180 mg * Hematocrit levels within normal limits * Having obtained his/her informed consent
Exclusion criteria
* Abnormal thyroid function * Creatinine \>2.0 mg/dl * Potassium \<3.5 mEq/l * Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting * Currently unstable diabetes or under treatment for cancer, heart disease, renal disease * Unable to give informed consent or follow instructions * Current insulin therapy or insulin therapy within the past month * Patient who are pregnant * Allergies to milk, soy or any component of the test product * Patient who in the investigators assessment cannot be expected to comply with treatment * Currently participating or having participated in another clinical trial * Patients with anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the blood glucose curve | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes | Area under the blood glucose curve (AUC 0-240 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the insulin curves | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes | Area under the insulin curves (AUC 0-240) |
| Insulinogenic index | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes | Insulinogenic index \[Change in Ins30/Change in Glu30\] |
Countries
United States
Outcome results
None listed