Plasma Glucose and Insulin Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

Société des Produits Nestlé (SPN)1 site in 1 country12 target enrollmentJuly 2016

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 12
Locations: 1
Primary Endpoint: Area under the blood glucose curve (AUC 0-240)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

September 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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

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)