VasodilationEarly Phase 1NCT05256069
Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
A Early Phase 1 study testing Propranolol Pill in people with Vasodilation and Hypoxia, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasodilation, Hypoxia
- What is being tested?
- Propranolol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 31 Jul 2025
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult men and women;
- 18-45 years of age;
- BMI 18-30 kg/m2;
- non-pregnant/non-breastfeeding;
- non-nicotine users;
Who cannot join
- Pregnancy, breastfeeding, hormonal contraceptives
- Diagnosed sleep apnea
- Current smoking/Nicotine use/drug use
- Nerve/neurologic disease
- Cardiovascular, hepatic, renal, respiratory disease
- Blood pressure ≥140/90 mmHg
Show all 10Show fewer
- Diabetes, Polycystic ovarian syndrome
- Communication barriers
- Prescription medications
- Recent COVID-19 diagnosis with symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65211
About this study
The purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.
- Conditions
- Vasodilation, Hypoxia
- Being tested
- Propranolol Pill, Placebo
- Medical subject headings
- Aneurysm, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol PillDrug
Participants will receive a β-blockade (propranolol pill, 1 mg/kg dosed based on participant weight).
PlaceboDrug
Participants will receive a placebo in pill form.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia Exposure | Experimental | Men and women will be exposed to isocapnic hypoxia. Participants will wear a mask and systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry. Receives: Drug: Propranolol Pill; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm Blood Flow
Measured with venous occlusion plethysmography (mL/dL/min)
Measured: Change from baseline to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start26 Apr 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VasodilationStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Jacqueline K Limberg, PhD, University of Missouri-Columbia
- Investigators
- Jacqueline K Limberg, Ph.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256069
- Sponsor's protocol ID
- 2087402
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jacob DW, Shariffi B, Bond BJ, Boyes NG, Martin SA, Gonsalves AM, Harper JL, Bostick BP, Limberg JK. beta-Adrenergic receptors mediate sex differences in vasodilation but not sympathetic-mediated vasoconstriction during hypoxia. Am J Physiol Heart Circ Physiol. 2025 Jul 1;329(1):H233-H240. doi: 10.1152/ajpheart.00192.2025. Epub 2025 Jun 4.
PubMed 40465513
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
- ClinicalTrials.gov ID
- NCT05256069
- Acronym / sponsor ID
- 2087402
- Conditions
- Vasodilation, Hypoxia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 25 Feb 2022 (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 project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoxia Exposure | Experimental | Drug: Propranolol Pill, Drug: PlaceboMen and women will be exposed to isocapnic hypoxia. Participants will wear a mask and systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy adult men and women;
- 18-45 years of age;
- BMI 18-30 kg/m2;
- non-pregnant/non-breastfeeding;
- non-nicotine users;
Key exclusion criteria (10 listed)
- Pregnancy, breastfeeding, hormonal contraceptives
- Diagnosed sleep apnea
- Current smoking/Nicotine use/drug use
- Nerve/neurologic disease
- Cardiovascular, hepatic, renal, respiratory disease
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 |
|---|---|---|
| Propranolol PillParticipants will receive a β-blockade (propranolol pill, 1 mg/kg dosed based on participant weight). | Drug | Hypoxia Exposure |
| PlaceboParticipants will receive a placebo in pill form. | Drug | Hypoxia Exposure |
Primary outcome
Forearm Blood Flow
Time frame: Change from baseline to 5 minutes
Measured with venous occlusion plethysmography (mL/dL/min)
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 15 Sep 2025.
- Derived from this study: PubMed 40465513Jacob DW, Shariffi B, Bond BJ, Boyes NG, Martin SA, Gonsalves AM, Harper JL, Bostick BP, Limberg JK. beta-Adrenergic receptors mediate sex differences in vasodilation but not sympathetic-mediated vasoconstriction during hypoxia. Am J Physiol Heart Circ Physiol. 2025 Jul 1;329(1):H233-H240. doi: 10.1152/ajpheart.00192.2025. Epub 2025 Jun 4.
- Individual participant dataSharing planned: Undecided
Related trials for Vasodilation
Active, not recruitingEarly Phase 1
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
Endothelial Function
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingEarly Phase 1
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
Aging, Menopause
RecruitingPhase 2
The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults
Frailty, Mild Cognitive Impairment
RecruitingEarly Phase 1
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
Obesity, Vasodilation
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.
Jacqueline K Limberg, Ph.D. principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propranolol Pill in people with Vasodilation and Hypoxia, run by University of Missouri-Columbia 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 5 inclusion and 10 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 15 Sep 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Forearm Blood Flow (time frame: Change from baseline to 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05256069, which also lists 1 linked publication.
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 15 Sep 2025.