A Study to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates (MK-0000-078)

Merck Sharp & Dohme LLC12 enrolled

Overview

A two period pilot study to determine if a graded glucose infusion using a glucose (20% dextrose \[D20\]) intravenous infusion can be properly implemented and will be well tolerated in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Comparator: graded infusion of intravenous glucosePROCEDURE

A stepwise graded infusion of glucose (20% dextrose \[D20\]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12mg/kg/min. Procedure will be identical in Period 1 and Period 2.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is in good health * Subject is a non-smoker Exclusion Criteria: * Subject has a history of hypertension requiring treatment * Subject has a history of cancer * Subject's parents of siblings have a history of type 2 diabetes * Subject is unable to refrain from the use of any prescription or non-prescription medication * Subject consumes excessive amounts of alcohol or caffeine * Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Outcomes

Primary Outcomes

proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels

Time frame: 0-160 minutes after start of infusion

Secondary Outcomes

beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)

Time frame: 0-160 minutes after start of infusion

Data from ClinicalTrials.gov

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