Plasma Glucose and Insulin Response in Persons with Type 2 Diabetes Mellitus

Société des Produits Nestlé (SPN)1 site in 1 country14 target enrollmentMay 18, 2020

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 14
Locations: 1
Primary Endpoint: Area under the blood glucose curve
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a randomized crossover design with nutrition supplement interventions.

Detailed Description

This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.

Registry

clinicaltrials.gov

Start Date

May 18, 2020

End Date

August 11, 2020

Last Updated

last year

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 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

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
•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

Outcomes

Primary Outcomes

Area under the blood glucose curve

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

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

Secondary Outcomes

Insulinogenic index(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
Area under the insulin curves(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)