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Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to support the hypothesis that glyburide, administered at the lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for treatment of brain injury.
This study is a placebo controlled (2:1 drug vs. placebo), randomized clinical trial of 21 healthy, non-diabetic volunteers receiving daily doses of oral glyburide (1.5 mg) vs. placebo while under careful medical monitoring in an inpatient General Clinical Research Center (GCRC) at the University of Maryland Medical Center, for a duration of 7 days. Subjects will participate in an informed consent process, and those wishing to take part will be asked to undergo a comprehensive interview detailing their past medical history and formal physical examination. If a subject is deemed appropriate by the team, he/she will be asked to perform an exercise test (treadmill for 30 minutes) and undergo laboratory assessments in addition to an Electrocardiogram (ECG) to further determine eligibility. Individuals who do not meet inclusion criteria based on screening activities will be notified immediately that they are not eligible. Volunteers meeting all eligibility criteria will be randomized to placebo vs. glyburide and will be scheduled for the week long in-patient evaluation.
Each subject will undergo a battery of physical, cognitive, and laboratory tests in addition to receiving oral glyburide or placebo each day for one week.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
glyburide, sugar pill
University of Maryland General Clinical Research Center (GCRC)
Not yet recruiting
University of Maryland
Published on BioPortfolio: 2014-07-24T14:00:45-0400
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