Exercise and Carotid Artery Function in Metabolic Syndrome

NCT07430839 | Recruiting

• 4 other identifiers: 2025-001725PRE1410388A176000Protocol Version 2/21/26
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine 1) if young adults with metabolic syndrome display endothelial dysfunction of the internal carotid artery in a sex-specific fashion and 2) if this endothelial dysfunction can be acutely improved with a single bout of exercise. This will be achieved by testing internal carotid artery function before and after a 30-minute bout of moderate intensity exercise. 48 young adults with and without metabolic syndrome will be enrolled and will be on study for approximately 5.5 hours over 4 study visits.

Conditions

Metabolic Syndrome

Keywords

exercise

Outcome Measures

Primary Outcomes (3)

• Aim 1: Baseline ICA cSMD measures assessed by MetSyn versus healthy controls

  Internal carotid artery cerebral shear-mediated dilation (cSMD) is measured by doppler ultrasound and reported in percentage increase in diameter. A resting baseline period for 5 minutes breathing room air followed by 30 seconds of breathing CO2-mixed air at +9 mmHg PETCO2 used to evoke an increase in blood flow to the ICA.

  baseline

• Aim 2: Baseline ICA cSMD measures assessed by MetSyn versus sex

  Internal carotid artery cerebral shear-mediated dilation is measured by doppler ultrasound and reported in percentage increase in diameter. A resting baseline period for 5 minutes breathing room air followed by 30 seconds of breathing CO2-mixed air at +9 mmHg PETCO2 used to evoke an increase in blood flow to the ICA.

  baseline

• Aim 3: Post-exercise cSMD response by MetSyn versus healthy controls

  Internal carotid artery cerebral shear-mediated dilation is measured by doppler ultrasound and reported in percentage increase in diameter. 30 minutes of exercise on a cycle ergometer will be performed at 80% of the ventilatory threshold determined during the graded exercise test.

  measured during exercise and 10 and 60 minutes post-exercise

Secondary Outcomes (1)

• Aim 3: Duration of Response to Exercise

  measured during exercise and 10 and 60 minutes post-exercise

Study Arms (4)

Young Male adults with MetSyn

* Graded Exercise Trial to determine cardiorespiratory fitness * Submaximal Exercise Trial to assess primary aims of the study (ICA function will be assessed using the cSMD test) * Sitting Control Trial (ICA function will be assessed using the cSMD test)

Behavioral: exercise; Diagnostic Test: Diagnostics; Other: Inhaled CO2-mixed air

Young Female adults with MetSyn

* Graded Exercise Trial to determine cardiorespiratory fitness * Submaximal Exercise Trial to assess primary aims of the study (ICA function will be assessed using the cSMD test) * Sitting Control Trial (ICA function will be assessed using the cSMD test)

Behavioral: exercise; Diagnostic Test: Diagnostics; Other: Inhaled CO2-mixed air

Young Male Healthy Controls

* Graded Exercise Trial to determine cardiorespiratory fitness * Submaximal Exercise Trial to assess primary aims of the study (ICA function will be assessed using the cSMD test) * Sitting Control Trial (ICA function will be assessed using the cSMD test)

Behavioral: exercise; Diagnostic Test: Diagnostics; Other: Inhaled CO2-mixed air

Young Female Healthy Controls

* Graded Exercise Trial to determine cardiorespiratory fitness * Submaximal Exercise Trial to assess primary aims of the study (ICA function will be assessed using the cSMD test) * Sitting Control Trial (ICA function will be assessed using the cSMD test)

Behavioral: exercise; Diagnostic Test: Diagnostics; Other: Inhaled CO2-mixed air

Interventions

exercise BEHAVIORAL

30 minute bout of cycling

Young Female Healthy Controls; Young Female adults with MetSyn; Young Male Healthy Controls; Young Male adults with MetSyn

Diagnostics DIAGNOSTIC_TEST

* Doppler Ultrasound used to non-invasively assess the diameter and blood flow going into an artery, the ICA in this study. * Indirect calorimeter in tandem with semi-recumbent bike used to assess O2 consumption * heart rate monitor

Young Female Healthy Controls; Young Female adults with MetSyn; Young Male Healthy Controls; Young Male adults with MetSyn

Inhaled CO2-mixed air OTHER

Three gases of different composition are used to ensure that the proper PETCO2 administration desired for this study occurs in tandem with keeping inspired O2 content constant. This is achieved by used a 5% O2, 95% CO2 tank, a 5% O2, 95% N2 tank, and a 100% O2 tank. In tandem, the use of these three tanks allows for precise control of PETCO2 without a change in inspired O2.

Young Female Healthy Controls; Young Female adults with MetSyn; Young Male Healthy Controls; Young Male adults with MetSyn

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young adult male and female participants with metabolic syndrome and age matched healthy male and female participants.

You may qualify if:

• Waist circumference greater than 102 cm (males) or 82 cm (females)
• Triglycerides over 150 mg/dL
• HDL cholesterol less than 40 mg/dL (males) or 50 mg/dL (females)
• Blood pressure ≥130/85 mmHg
• Fasting plasma glucose over 110 mg/dL
• \- meet age criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Interventions

Exercise; Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• William Schrage, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Bolin, MS

CONTACT

608-263-6308; sbolin@wisc.edu

Logan Heenan, BS

CONTACT

608-263-6308; lheenan@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)