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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Period 1 + Period 2

graded infusion of intravenous glucose

Group Type EXPERIMENTAL

Comparator: graded infusion of intravenous glucose

Intervention Type PROCEDURE

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.

Interventions

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Comparator: graded infusion of intravenous glucose

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes