Healthy
Conditions
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.
Interventions
PROCEDUREComparator: 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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) | 0-160 minutes after start of infusion |
Outcome results
None listed