Recruiting

Exercise

Sponsor:

University of Wisconsin, Madison

Code:

NCT07430839

Conditions

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

exercise

Diagnostics

Inhaled CO2-mixed air

Study Details

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

Study ID

NCT07430839

Start date

Dec 1, 2025

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria (MetSyn cohort):

  • 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

Inclusion Criteria (Healthy cohort):

\- meet age criteria

Exclusion Criteria:

  • 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
  • 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 oral contraceptives
  • Hormonal contraceptive use, such as intrauterine device or hormonal implant use
  • Participants with ICAs unsuitable for imaging, as assessed during the screening visit via doppler ultrasonography

Exclusion Criteria (healthy controls only):

  • BMI greater than 25 kg/m2
  • Blood pressure over 125/80 mmHg
  • Meeting any MetSyn criteria listed for MetSyn cohort

Study Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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)

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)

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)

Interventions

exercise

30 minute bout of cycling

Diagnostics

  • 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

Inhaled CO2-mixed air

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.

Primary outcome measure

  • Aim 1: Baseline ICA cSMD measures assessed by MetSyn versus healthy controls [ Time Frame: baseline ]
  • Aim 2: Baseline ICA cSMD measures assessed by MetSyn versus sex [ Time Frame: baseline ]
  • Aim 3: Post-exercise cSMD response by MetSyn versus healthy controls [ Time Frame: measured during exercise and 10 and 60 minutes post-exercise ]

Central Contacts and Locations

Central contacts

Shawn Bolin, MS

608-263-6308sbolin@wisc.edu

Logan Heenan, BS

608-263-6308lheenan@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 25, 2026

Last verified

Feb, 2026

Keywords

  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-25.