Differing Levels of Hypoglycemia
ConditionHypoglycemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Maryland, Baltimore
About this trial
Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To date no studies appear to have investigated the effects of differing levels of hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The specific aim of our study will be to determine the effects of differing levels of hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Pregnant women
Subjects unwilling or unable to comply with approved contraception measures
Subjects unable to give voluntary informed consent
Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
Trial design
Design model
Crossover
Treatments tested in this trial
Glucose clamp
DeviceDifferent levels of hypoglycemia
Treatment groups
32 Participants
are divided into 4 treatment groupsGroup A: 90 mg/dl glucose clampExperimental treatment 1 intervention
Group B: 70 mg/dl glucose clampExperimental treatment 1 intervention
Group C: 60 mg/dl glucose clampExperimental treatment 1 intervention
Group D: 50 mg/dl glucose clampExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Flow mediated vasodilation of brachial artery measurements (mean maximum % change)
baseline (pre) measurements compared to end of clamp (post) measurements
Time frame
120 minutes (pre) clamp and 240 minutes (post) clampSponsors and contacts
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University of Maryland, Baltimore
Lead sponsor
Vanderbilt University
Collaborator
Source ClinicalTrials.gov