CompletedEarly Phase 1

Human Cerebral Blood Flow Regulation

United States42 participantsStarted 2021-04-12

Plain-language summary

To determine cerebrovascular control mechanisms in humans and provide mechanistic knowledge to offer new sex-specific therapeutic options for cerebrovascular diseases. The current objective is to determine how sex and sex hormones influence CBF control in healthy young adults without confounds of age or disease. The central hypothesis is men exhibit reduced cerebral vasodilator function due in part to differences in COX signaling compared to women. Comprehensive CBF data from multi-modal MRI indicate the magnitude of sex differences-as well as the vasodilator mechanisms-are regionally distinct. Research confounding variables like aging and disease will be mitigated by comparing younger adults (18-40 years old).

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All participants will be healthy adults between 18-40 years old, matched for age and aerobic fitness * Participants will be non-hypertensive (\<125/80mm Hg) * Participants will be non-obese (BMI 19-25 kg/m2) * Participants will have normal blood glucose (\<100 g/dl) * Participants will have normal lipids (LDL cholesterol \<130 mg/dl, triglycerides \<150 mg/dl) * Women must have a natural regular menstrual cycle Exclusion Criteria: * Participants with a history of: * peripheral vascular disease * hepatic disease * renal disease * hematologic disease * stroke * obesity * prediabetes * diabetes * sleep apnea * Participants with current BP\>130/85 mmHg * Regular smokers * Taking cardiovascular medications * Women who take hormonal birth control * Women who are pregnant or have polycystic ovarian syndrome \[Hormonal birth control will not be allowed in women\] * Contradictions to MRI * Lactose intolerance

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cerebrovascular Conductance (CVC) in Response to Hypoxia, Male vs Female

Timeframe: up to 75 minutes for entire visit, but hypoxia lasts about 20 minutes

CVC in Response to Hypercapnia, Male vs Female

Timeframe: up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes

Trial details

NCT IDNCT04265053

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

Results submitted2026-03-31

View on ClinicalTrials.gov More Cerebral Arterial Diseases trials