Investigating how men and women regulate blood flow in the brain
Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences
This study looks at how men and women manage blood flow in the brain during stress to see if there are differences and what causes them.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT04265053 on ClinicalTrials.gov |
What this trial studies
This study explores the differences in cerebral blood flow (CBF) regulation between men and women, particularly under stress conditions like low oxygen or high carbon dioxide. By administering various medications and using advanced MRI techniques, the researchers aim to uncover the physiological mechanisms that contribute to these differences. The study focuses on healthy adults aged 18-40, minimizing confounding factors such as age and comorbidities. The ultimate goal is to enhance understanding of cerebrovascular disease risk and its relationship with sex and hormonal influences.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-40 who are non-hypertensive, non-obese, and have normal blood glucose and lipid levels.
Not a fit: Patients with a history of cerebrovascular disease, obesity, or those taking hormonal birth control may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved prevention and treatment strategies for cerebrovascular diseases, particularly by understanding sex-specific mechanisms.
How similar studies have performed: While studies have explored sex differences in cerebrovascular health, this specific approach focusing on younger adults and the physiological mechanisms remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin, Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: William Schrage, PhD — University of Wisconsin, Madison
- Study coordinator: Shawn E Bolin, MS
- Email: sbolin@wisc.edu
- Phone: 608-263-6308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.