Diabetes Mellitus, Type 2
Conditions
Brief summary
This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
Interventions
Product intake of oral nutrition supplement provided
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Study staff will not be blinded to product assignment. Study participants will be blinded to product assignment. Product will be provided in unlabeled plastic cups.
Intervention model description
This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subject inclusion criteria All subjects must comply with all the following 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 Subject
Exclusion criteria
Subjects representing one or more of the following criteria are excluded from participation in the study. * 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 |
|---|---|
| Area under the blood glucose curve (ACU 0-240 minutes) | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Area under the insulin curves (AUC 0-240) | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
| Insulinogenic index [Change in Ins30/Change in Glu30] | [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes] |
Countries
United States
Outcome results
None listed