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Sex-Specific Cerebrovascular Dysfunction in Metabolic Syndrome-Role of COX

NCT07218653 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-10-20

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

Indomethacin

Indomethacin is a nonsteroidal anti-inflammatory. It prevents the production of prostaglandins, endogenous signaling molecules known to cause symptoms from inflammation. Indomethacin (1.5 mg/kg) will be taken orally prior to one MRI study visit.

DRUG

Placebo

Participants will be screened for lactose intolerance. Total dosing will be calculated to match the mg needed for the indomethacin study visit.

DIAGNOSTIC_TEST

MRI

CBF testing will be performed on 3T MRI scanners (GE Healthcare)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • William Schrage, PhD · UW Madison

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2031-07-31
Completion
2031-07-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218653 on ClinicalTrials.gov