Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

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

ConditionsDiabetes

Overview

This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

•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/GlucotrolXL) 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

•Abnormal thyroid function
•Creatinine \>2.0 mg/dL
•Potassium \<3.5 mEq/L
•Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
•History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
•Patients currently on any anti-coagulant medication
•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

Area under the blood glucose curve (AUC 0-240)

Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Area under the insulin curves (AUC 0-240)(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)
AUC (0-30min) for insulin(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)