Metabolic SyndromeNCT07430839
Exercise and Carotid Artery Function in Metabolic Syndrome
An observational study of Metabolic Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- exercise, Diagnostics and Inhaled CO2-mixed air
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adult male and female participants with metabolic syndrome and age matched healthy male and female participants.
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- BMI greater than 25 kg/m2
- Blood pressure over 125/80 mmHg
- Meeting any MetSyn criteria listed for MetSyn cohort
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
About this study
Official title: Identifying Sex-specific Carotid Endothelial Dysfunction in Young Adults With Metabolic Syndrome
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.
Read the detailed description
The goal of this project is to determine if young MetSyn patients exhibit carotid endothelial dysfunction (ED) in a sex-specific manner and if exercise can acutely restore internal carotid artery (ICA) function.
The investigators will test this by first quantifying ICA endothelial function using an inhaled gas stressor (CO2) to acutely increase ICA shear rate (SR) and measuring the vascular responsiveness to this increased SR. Carotid endothelial function has never been tested in this way in patients with MetSyn before. Then, a 30 min bout of cycling exercise will be performed followed by the same gas stressor test to determine if ICA endothelial function can be acutely improved in MetSyn.
The aims and hypotheses are to:
- Aim 1: Determine if young adults with MetSyn exhibit carotid ED compared to healthy adults. Hypothesis: carotid ED will be present in young adults with MetSyn.
- Aim 2: Determine if sex differences exist in carotid endothelial function in MetSyn. Hypothesis: MetSyn will result in greater declines in carotid endothelial function in females.
- Aim 3: Determine if exercise yields an acute benefit on carotid endothelial function in young adults with MetSyn. Hypothesis: young adults with MetSyn will receive a greater increase in carotid endothelial function from a single bout of exercise than healthy adults.
- Conditions
- Metabolic Syndrome
- Being tested
- exercise, Diagnostics, Inhaled CO2-mixed air
- Keywords
- exercise
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
30 minute bout of cycling
DiagnosticsDiagnostic 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
Inhaled CO2-mixed airOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Behavioral: exercise; Diagnostic Test: Diagnostics; Other: Inhaled CO2-mixed air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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: measured during exercise and 10 and 60 minutes post-exercise
Secondary outcomes (1)
Aim 3: Duration of Response to Exercise
Duration of post-exercise improvements will be investigated by testing ICA cSMD 10 min and 60 min post-exercise. 30 minutes of exercise on a cycle ergometer will be performed at 80% of the ventilatory threshold determined during the graded exercise test. For the duration of the exercise, indirect calorimetry will be used to assess VO2 to confirm the target workload of 80% of the ventilatory threshold. During this 30 minutes of exercise, ICA diameter and velocity will be measured using ultrasonography every 5 minutes for a 2-minute period.
Measured: measured during exercise and 10 and 60 minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Schrage, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430839
- Sponsor's protocol ID
- 2025-0017
- Other IDs
- 25PRE1410388, A176000, Protocol Version 2/21/26
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Sex-specific Carotid Endothelial Dysfunction in Young Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07430839
- Acronym / sponsor ID
- 2025-0017
- Conditions
- Metabolic Syndrome
- Keywords
- exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this project is to determine if young MetSyn patients exhibit carotid endothelial dysfunction (ED) in a sex-specific manner and if exercise can acutely restore internal carotid artery (ICA) function.
The investigators will test this by first quantifying ICA endothelial function using an inhaled gas stressor (CO2) to acutely increase ICA shear rate (SR) and measuring the vascular responsiveness to this increased SR. Carotid endothelial function has never been tested in this way in patients with MetSyn before. Then, a 30 min bout of cycling exercise will be performed followed by the same gas stressor test to determine if ICA endothelial function can be acutely improved in MetSyn.
The aims and hypotheses are to:
- Aim 1: Determine if young adults with MetSyn exhibit carotid ED compared to healthy adults. Hypothesis: carotid ED will be present in young adults with MetSyn.
- Aim 2: Determine if sex differences exist in carotid endothelial function in MetSyn. Hypothesis: MetSyn will result in greater declines in carotid endothelial function in females.
- Aim 3: Determine if exercise yields an acute benefit on carotid endothelial function in young adults with MetSyn. Hypothesis: young adults with MetSyn will receive a greater increase in carotid endothelial function from a single bout of exercise than healthy adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young Male adults with MetSyn | – | Behavioral: exercise, Diagnostic Test: Diagnostics, Other: Inhaled CO2-mixed air* 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 | – | Behavioral: exercise, Diagnostic Test: Diagnostics, Other: Inhaled CO2-mixed air* 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 | – | Behavioral: exercise, Diagnostic Test: Diagnostics, Other: Inhaled CO2-mixed air* 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 | – | Behavioral: exercise, Diagnostic Test: Diagnostics, Other: Inhaled CO2-mixed air* 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adult male and female participants with metabolic syndrome and age matched healthy male and female participants.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- Current smoker, defined as more than 5 cigarettes over past 30 days
- Current diagnosis or history of:
- Type II diabetes
- Currently pregnant or breastfeeding
- Current musculoskeletal injury Medication use known to influence cardiovascular function, other than oral contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise30 minute bout of cycling | Behavioural | Young Female Healthy Controls, Young Female adults with MetSyn, Young Male Healthy Controls, Young Male adults with MetSyn |
| 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 | Diagnostic test | Young Female Healthy Controls, Young Female adults with MetSyn, Young Male Healthy Controls, Young Male adults with MetSyn |
| Inhaled CO2-mixed airThree 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. | Other | Young Female Healthy Controls, Young Female adults with MetSyn, Young Male Healthy Controls, Young Male adults with MetSyn |
Primary outcome
Aim 1: Baseline ICA cSMD measures assessed by MetSyn versus healthy controls
Time frame: baseline
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.
Aim 2: Baseline ICA cSMD measures assessed by MetSyn versus sex
Time frame: baseline
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.
Aim 3: Post-exercise cSMD response by MetSyn versus healthy controls
Time frame: measured during exercise and 10 and 60 minutes post-exercise
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.
1 secondary outcome
Aim 3: Duration of Response to Exercise
Time frame: measured during exercise and 10 and 60 minutes post-exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Schrage, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shawn Bolin, MS (608-263-6308, sbolin@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Baseline ICA cSMD measures assessed by MetSyn versus healthy controls (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.