NCT02856516CompletedNot Applicable
Plasma Glucose and Insulin Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Société des Produits Nestlé (SPN)2 sites in 1 country12 target enrollmentStarted: July 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Area under the blood glucose curve (AUC 0-240)
Study Overview
Brief Summary
This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.
Detailed Description
Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 20-75 yrs
- •Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- •Hemoglobin A1C less than 9.0%
- •Fasting blood glucose less than 180 mg
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
- •Patients 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.
Outcomes
Primary Outcomes
Area under the blood glucose curve (AUC 0-240)
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary Outcomes
- Area under the insulin curves (AUC 0-240)(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
- AUC (0-30min) for insulin(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
- Insulinogenic index (Ins30/(Glu30)(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
Investigators
Study Sites (2)
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