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

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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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: graded infusion of intravenous glucose

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.

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, 2-Period, Pilot Study in Healthy Male Subjects to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Nov 30, 2009
Registry last updated: Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed