Metabolic Syndrome, Sex Differences, and Brain Blood Flow Study

This study is looking for healthy adults and those with Metabolic Syndrome, aged 18-45, to understand how Metabolic Syndrome affects blood flow in the brain, especially looking at differences between men and women. You would receive either Indomethacin (a common anti-inflammatory drug) or a placebo (an inactive substance) and undergo MRI scans to measure your brain's blood flow. The goal is to see if Metabolic Syndrome reduces brain blood flow more in women than in men, and if a specific signaling pathway (COX vasodilation) plays a role. The study plans to enroll 72 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 72 participants, comparing healthy controls with individuals who have Metabolic Syndrome. Participants will receive either Indomethacin or a placebo.
What's involved
You would have a screening visit with a blood test, followed by three laboratory visits, each lasting about 2 hours. These visits, including an MRI scan, must be completed within 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your brain blood flow will be measured over two study visits that must be completed within 6 months.

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NCT07218653

Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome

Not Yet Recruiting
EARLY_PHASE1Ages 18–45InterventionalBasic science
University of Wisconsin, Madison
~72 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:IndomethacinPlaceboMRI

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cerebral Blood Flow
Measured over data collected over 2 study visits that must be completed within 6 months
Metabolic Syndrome
1 sites across 1 states
Wisconsin1
  • William Schrage, PhD · PRINCIPAL_INVESTIGATOR · UW Madison

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Eligibility criteria

Inclusion

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.
18-45 years old
Meet at least 3 of the 5 ATP MetSyn criteria. These are:

Exclusion

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
Current diagnosis or history of:
peripheral vascular disease
hepatic disease
renal disease
lung disease
gastrointestinal disorders/bleeding
hematologic disease
stroke
myocardial infarction
coronary heart disease
congestive heart failure
heart surgery
sleep apnea
autoimmune diseases
HIV
traumatic brain injury, concussion, stroke, or seizures
Asthma
Polycystic ovarian syndrome
Type II diabetes
Currently pregnant or breastfeeding
Current musculoskeletal injury
Medication use known to influence cardiovascular function, other than contraceptive hormones. Broadly, the classes of drugs relate to treating blood pressure, diabetes, cholesterol.
Claustrophobia
Lactose intolerance
Magnesium-restricted diet
  • Cerebral Blood Flowdata collected over 2 study visits that must be completed within 6 months

    Data collected via MRI under one of 2 conditions: placebo or indomethacin.