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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01021462
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-30
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels	0-160 minutes after start of infusion

Secondary Outcome Measures

Name	Time	Method
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)	0-160 minutes after start of infusion