Endothelial DysfunctionNCT06163456
Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults
A study testing Acute submaximal exercise in people with Endothelial Dysfunction and Arterial Stiffness, run by Towson University at 1 site in United States.
Trial summary
This research is being done to determine whether acute exercise causes differences in numbers of novel blood factors associated with vascular health in college-aged adults across different physical activity habits. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Arterial Stiffness
- What is being tested?
- Acute submaximal exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-29 years of age; healthy male and female; Physically inactive, defined as participation in less than 20 min of continuous endurance exercise on fewer than 2 days/week; Recreationally active, defined as participation in 30 min/day of moderate-intensity cardiovascular activity on greater than 4 days/week; Highly active- defined as performing 30-60 min of moderate- to vigorous-intensity endurance exercise greater than 5 days/week.
Who cannot join
- currently pregnant, previously diagnosed coronary heart disease or congenital heart disease, serum total cholesterol >200 mg/dl, low-density lipoprotein cholesterol >130 mg/dl, high-density lipoprotein cholesterol < 35 mg/dl, fasting glucose >100 mg/dl, systolic blood pressure > 130 mmHg, diastolic blood pressure >90 mmHg, and BMI >30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to determine whether acute exercise causes differences in numbers of novel blood factors associated with vascular health in college-aged adults across different physical activity habits. As only ~50% of cardiovascular (CV) events can be explained by traditional CV risk factors such as high blood pressure and high cholesterol, it is anticipated that this research will provide a more comprehensive look into novel risk factors that may better explain CV risk and that may be modifiable through regular physical activity.
- Conditions
- Endothelial Dysfunction, Arterial Stiffness
- Being tested
- Acute submaximal exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute submaximal exerciseOther
30 min of treadmill running at 70% of the participants maximal oxygen consumption
| Study group | Role | What they receive |
|---|---|---|
| low fitness | Experimental | Not described Receives: Other: Acute submaximal exercise |
| moderate fitness | Active comparator | Not described Receives: Other: Acute submaximal exercise |
| high fitness | Active comparator | Not described Receives: Other: Acute submaximal exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
flow-mediated dilation
Measured: Baseline and 60 min post-exercise
arterial stiffness
augmentation index
Measured: Baseline and 60 min post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start2 Dec 2019
- Primary completion15 Mar 2020
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Towson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rian Q. Landers-Ramos, Towson University
- Investigators
- Rian Q Landers-Ramos, PhD, Principal investigator, Towson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163456
- Sponsor's protocol ID
- 1810041426
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults
- ClinicalTrials.gov ID
- NCT06163456
- Acronym / sponsor ID
- 1810041426
- Conditions
- Endothelial Dysfunction, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Towson UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 8 Dec 2023 (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.
This research is being done to determine whether acute exercise causes differences in numbers of novel blood factors associated with vascular health in college-aged adults across different physical activity habits. As only ~50% of cardiovascular (CV) events can be explained by traditional CV risk factors such as high blood pressure and high cholesterol, it is anticipated that this research will provide a more comprehensive look into novel risk factors that may better explain CV risk and that may be modifiable through regular physical activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low fitness | Experimental | Other: Acute submaximal exercise |
| moderate fitness | Active comparator | Other: Acute submaximal exercise |
| high fitness | Active comparator | Other: Acute submaximal exercise |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-29 years of age; healthy male and female; Physically inactive, defined as participation in less than 20 min of continuous endurance exercise on fewer than 2 days/week; Recreationally active, defined as participation in 30 min/day of moderate-intensity cardiovascular activity on greater than 4 days/week; Highly active- defined as performing 30-60 min of moderate- to vigorous-intensity endurance exercise greater than 5 days/week.
Key exclusion criteria (1 listed)
- currently pregnant, previously diagnosed coronary heart disease or congenital heart disease, serum total cholesterol >200 mg/dl, low-density lipoprotein cholesterol >130 mg/dl, high-density lipoprotein cholesterol < 35 mg/dl, fasting glucose >100 mg/dl, systolic blood pressure > 130 mmHg, diastolic blood pressure >90 mmHg, and BMI >30 kg/m2.
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 |
|---|---|---|
| Acute submaximal exercise30 min of treadmill running at 70% of the participants maximal oxygen consumption | Other | high fitness, low fitness, moderate fitness |
Primary outcome
endothelial function
Time frame: Baseline and 60 min post-exercise
flow-mediated dilation
arterial stiffness
Time frame: Baseline and 60 min post-exercise
augmentation index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Endothelial Dysfunction
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
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. This study is not recruiting at the moment.
Rian Q Landers-Ramos, PhD principal investigator
Towson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute submaximal exercise in people with Endothelial Dysfunction and Arterial Stiffness, run by Towson University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function (time frame: Baseline and 60 min post-exercise). The study lists 2 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 8 Dec 2023.