Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07218653
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Indomethacin — DRUG
    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.
  • Placebo — DRUG
    Participants will be screened for lactose intolerance. Total dosing will be calculated to match the mg needed for the indomethacin study visit.
  • MRI — DIAGNOSTIC_TEST
    CBF testing will be performed on 3T MRI scanners (GE Healthcare)

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Oct 2025
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Healthy controls
    Male and female participants 18-45 without Metabolic Syndrome. On study for 3 visits (up to 6 months). Randomized to either Placebo then Indomethacin or Indomethacin then Placebo for 2 MRI visits.
  • Experimental: Metabolic Syndrome
    Male and female participants, age-matched with Healthy Controls, who have at least 3 defining symptoms of Metabolic Syndrome. Randomized to either Placebo then Indomethacin or Indomethacin then Placebo for 2 MRI visits.

Primary Outcome Measure

Cerebral Blood Flow [ Time Frame: data collected over 2 study visits that must be completed within 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53706-

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By research site
University of Wisconsin· Madison, WI

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