Status:
NOT_YET_RECRUITING
Sex-Specific Cerebrovascular Dysfunction in Metabolic Syndrome-Role of COX
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
Brief 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 femal...
Detailed Description
The central hypothesis is that MetSyn decreases CBF more in females than males due in part to the sex-specific loss of COX vasodilation. This hypothesis is based on extensive preliminary data demonstr...
Eligibility Criteria
Inclusion
- 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 history of a neurocognitive disorder or an intellectual disability will be excluded from the study. A neurocognitive screener (MoCA) will be completed; a score below the normal range (25 or below) is exclusionary. Participants will complete the Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) to screen for symptoms of depression and anxiety to increase the translatability of data; normal to mildly elevated range (0-9) are included but excluded at higher scores (10-27).
Exclusion
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07218653
Start Date
July 1 2026
End Date
July 1 2031
Last Update
October 20 2025
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