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
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