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Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome

ConditionMetabolic 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: Healthy Controls versus participants with MetSyn.

Eligibility criteria

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • 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)

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Healthy controlsExperimental treatment 3 interventions
Group B: Metabolic SyndromeExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Cerebral Blood Flow

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

Time frame
data collected over 2 study visits that must be completed within 6 months

Secondary outcomes

1

Cardiorespiratory Fitness: VO2 max

Graded exercise test to assess maximal aerobic capacity, reported as VO2 max (milliliters of oxygen consumed per kilogram of body weight per minute)

Time frame
data collected at one study visit (must be completed within 6 months)
2

Body Fat Mass

Dual-energy x-ray absorptiometry (DEXA) to measure fat mass.

Time frame
data collected at one study visit (must be completed within 6 months)
3

Cognitive Testing: Flanker Inhibitory Control and Attention

NIH Toolbox to assess neurocognitive function. The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance.

Time frame
data collected at one study visit (must be completed within 6 months)
4

Cognitive Testing: Pattern Comparison Processing Speed Test

NIH Toolbox to assess neurocognitive function. The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds. There is a maximum of 130 items.

Time frame
data collected at one study visit (must be completed within 6 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: