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The purpose of this trial is to study the brain response using functional MRI (fMRI) before and after varying doses of insulin given through the nose. The magnetic resonance imaging uses a very strong magnet to produce images of participant's brain. It becomes a functional MRI when the study team looks at the activity within the brain (blood flow / change in metabolism).
If cardiac arrest is not treated immediately, it causes sudden death. Intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest or other brain injury. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin reduces brain injury in animal experiments and has been used to try to improve brain degeneration in patients with Alzheimer's disease in doses up to 160 units.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal insulin and placebo | Experimental | A total of 3 possible doses will be tested of insulin 0 units (u) (placebo (diluent), 500u, and 1000u. The order that participants will receive these doses will be in a random order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal insulin | Drug | Enrolled Participants for this trial will come for 3 study visits. The doses will be administered in varying order: participants will be randomized to one six possible permutations of the intranasal study doses (0, 500, 1000 U) of intranasal insulin at each visit. Participants will undergo a fMRI scan before and after receiving intranasal doses. Additionally, participants will have blood samples taken. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Signal response using fMRI after administration of intranasal insulin | Values of regions of interest in the fMRI will be calculated for all measures, including cerebral blood flow (CBF), at different used dosages and compared directly as well as with baseline-corrected CBF maps. The study team will determine if a significant difference at different dosages exists. | Baseline fMRI (approximately 30 minutes), fMRI Approximately 30 minutes (after insulin dose administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Glucose (serum or point of care capillary) | Baseline (Immediately before drug administration), up to approximately 90 minutes (after drug dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Schmitzberger, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Each volunteer will have 3 study visits, receiving a different study dose at each visit in randomized order as spelled out in the protocol.
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