Plasma Glucose and Insulin Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus

Société des Produits Nestlé (SPN)1 site in 1 country13 target enrollmentApril 5, 2017

ConditionsDiabetes

Overview

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

Registry

clinicaltrials.gov

Start Date

April 5, 2017

End Date

May 18, 2017

Last Updated

8 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/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
•Hemoglobin A1C less than 9.0%
•Fasting blood glucose less than 180 mg
•Hematocrit levels within normal limits

•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

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 [Change in Ins30/Change in 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)