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NCT02936687 · ClinicalTrials.gov registry record · Phase 1
Mechanisms of Cerebrovascular Control
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT02936687 is a Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 59 participants.
The verdict
NCT02936687, a Phase 1 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
The objective of this study is to identify insulin-specific cerebral blood flow (CBF) control mechanisms, and establish cerebrovascular responsive baseline in younger (18-45 yrs) metabolic syndrome adults (MetSyn) who are at substantial risk of stroke and other types of cardiovascular mortality even if they never develop diabetes. The central hypothesis is that vasodilator actions of insulin are impaired in MetSyn due to loss of dilator and gain of constrictor signals. This study will focus on 2 mechanisms that likely limit CBF in MetSyn: 1) Disruption of nitric oxide (NO) vasodilation, and 2) Exaggerated endothelin (ET-1) constriction. Three specific aims will be addressed: Aim 1: To test the hypothesis that physiologic surges of insulin acutely increase CBF in young adults, but adults with MetSyn exhibit paradoxical insulin-mediated vasoconstriction. Aim 2: To test the hypotheses that key mechanisms responsible for poor CBF in MetSyn are shifts in NO and ET-1 signaling. Specifically, in healthy controls, NO mediates robust dilation, with little to no ET-1 constriction. In contrast, adults with MetSyn exhibit uncoupled NO synthase (NOS) and exaggerated ET-1 constriction. Aim 3: To test the hypothesis that insulin regulation of CBF is regionally distinct (e.g. Middle Cerebral Artery (MCA) reactive than Anterior Cerebral Artery (ACA) or basilar), and the negative effects of insulin resistance (IR) are similarly regionally specific.
Interventions
- DEVICE 3 Tesla MRI
- DEVICE Intravenous Catheter
- DRUG NOS Inhibition
- DRUG ET-1 Inhibition
- DRUG NOS Inhibition Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02936687
The ClinicalTrials.gov registry entry for NCT02936687 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which 3 Tesla MRI is the first listed.
NCT02936687 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02936687 about?
NCT02936687 is a clinical study titled "Mechanisms of Cerebrovascular Control". The objective of this study is to identify insulin-specific cerebral blood flow (CBF) control mechanisms, and establish cerebrovascular responsive baseline in younger (18-45 yrs) metabolic syndrome adults (MetSyn) who are at substantial risk of stroke and other types of cardiovascular mortality even...
What is the current status of trial NCT02936687?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2017-01-31. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT02936687?
The interventions under investigation include: 3 Tesla MRI (DEVICE), Intravenous Catheter (DEVICE), NOS Inhibition (DRUG), ET-1 Inhibition (DRUG), NOS Inhibition Placebo (DRUG).
Who is sponsoring clinical trial NCT02936687?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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