Sex-Specific Cerebrovascular Dysfunction in Metabolic Syndrome-Role of COX (NCT07218653) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Sex-Specific Cerebrovascular Dysfunction in Metabolic Syndrome-Role of COX
72 participantsStarted 2026-07
Plain-language summary
This study tests the hypothesis that Metabolic Syndrome (MetSyn) decreases cerebral blood flow (CBF) more in females than males due in part to the sex-specific loss of COX vasodilation. Male and female participants will be enrolled in two groups: Health Controls versus participants with MetSyn.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria (Healthy Controls):
* non-hypertensive (less than 130/80 mmHg)
* non-obese with a Body Mass Index (BMI) less than 30 kilogram per meter squared (kg/m2)
* Normal blood glucose less than 100 grams per deciliter (g/dl)
* Normal lipids; LDL cholesterol less than130 milligrams per deciliter (mg/dl), triglycerides less than 150 mg/dl.
* Women must have a predictable menstrual cycle for MRI scheduling. Females will be studied on cycle days 1-7 (as presented in all preliminary data) to minimize sex hormone differences and their potential confounding effects on vascular outcomes. Oral contraceptives will be allowed in women to increase translatability in findings.
Inclusion Criteria (Participants with Metabolic Syndrome):
* Meet age criteria plus three or more of the five criteria for MetSyn as defined by ATP, the most common three factors meeting MetSyn criteria will be obesity, prehypertension / hypertension, and low HDL cholesterol.
Exclusion Criteria:
* Subjects with a diagnostic history of:
* peripheral vascular, hepatic, renal, or hematologic disease
* stroke
* type 1 or 2 diabetes
* sleep apnea
* hypertension (allowed in MetSyn)
* regular tobacco users
* taking cardiovascular medications (e.g., statins, angiotensin II receptor blockers) or metabolic medications (metformin, insulin, semaglutide) or NSAID sensitivity will be excluded.
* In women: pregnancy or polycystic ovarian syndrome (PCOS, to avoid altered testosterone in women).
* A his…
What they're measuring
1
Cerebral Blood Flow
Timeframe: data collected over 2 study visits that must be completed within 6 months