Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

Qualifiers

18-45 years old

Normal fasting values for blood glucose (less than 100 g/dl)

Normal values for lipids (LDL cholesterol less than 130 mg/dl, triglycerides less than 150 mg/dl) and HDL (men greater than 40, women greater than 50 mg/dl)

Women must have a predictable menstrual cycle. Females will be studied on cycle days 1-7 to minimize sex hormone differences and their potential confounding effects on vascular outcomes. Oral contraceptives are allowed, and women will be studied during their placebo phase.

Disqualifiers

Body Mass Index (BMI) greater than or equal to 25 kg/m2

Blood pressure over 130/80 mmHg

Meeting any of the 5 MetSyn criteria listed above.

Current smoker, defined as more than 5 cigarettes over past 30 days

Trial design

Treatments tested in this trial

  • Indomethacin
  • Placebo
  • MRI

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Wisconsin, Madison

Lead sponsor

National Institutes of Health (NIH)

Collaborator