ObesityEarly Phase 1NCT04436731
Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
A Early Phase 1 study testing Cold Pressor Test in people with Obesity and Healthy, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Healthy, Vasoconstriction
- What is being tested?
- Cold Pressor Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 2 Jul 2026
- 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
- 18-45 years of age (premenopausal)
- Healthy weight (BMI ≥18 and ≤25 kg/m2)
- Obese (BMI ≥30 kg/m2)
Who cannot join
- Pregnancy, breastfeeding, oral hormonal contraceptive use
- Diagnosed sleep apnea or Oxygen desaturation index >10 events/hr
- Current smoking/Nicotine use
- Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
- Nerve/neurologic disease
- Cardiovascular, hepatic, renal, respiratory disease
Show all 10Show fewer
- Blood pressure ≥140/90 mmHg
- Diabetes, Polycystic ovarian syndrome
- Communication barriers
- Prescription medications, Sensitivity to lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65211
About this study
Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.
- Conditions
- Obesity, Healthy, Vasoconstriction, Vasodilation
- Being tested
- Cold Pressor Test
- Medical subject headings
- Obesity, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Pressor TestOther
Participants will complete the cold pressor test during the final 2 min of normoxia and hypoxia.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia Exposure | Experimental | Participants will undergo room air (normoxic) and low oxygen (hypoxic) conditions. Receives: Other: Cold Pressor Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forearm vascular conductance with cold pressor test
Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.
Measured: Continuous measurement of vascular conductance during cold pressor test (final 2 min of normoxia and hypoxia).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start9 Dec 2020
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline K Limberg, PhD, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436731
- Sponsor's protocol ID
- 2022525
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2020
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
- ClinicalTrials.gov ID
- NCT04436731
- Acronym / sponsor ID
- 2022525
- Conditions
- Obesity, Healthy, Vasoconstriction, Vasodilation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 18 Jun 2020 (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.
Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.
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 | Other: Cold Pressor TestParticipants will undergo room air (normoxic) and low oxygen (hypoxic) conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years of age (premenopausal)
- Healthy weight (BMI ≥18 and ≤25 kg/m2)
- Obese (BMI ≥30 kg/m2)
Key exclusion criteria (10 listed)
- Pregnancy, breastfeeding, oral hormonal contraceptive use
- Diagnosed sleep apnea or Oxygen desaturation index >10 events/hr
- Current smoking/Nicotine use
- Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
- Nerve/neurologic 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 |
|---|---|---|
| Cold Pressor TestParticipants will complete the cold pressor test during the final 2 min of normoxia and hypoxia. | Other | Hypoxia Exposure |
Primary outcome
Change in forearm vascular conductance with cold pressor test
Time frame: Continuous measurement of vascular conductance during cold pressor test (final 2 min of normoxia and hypoxia).
Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.
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 28 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cold Pressor Test in people with Obesity and Healthy, 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 3 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 28 Jul 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.
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?
Change in forearm vascular conductance with cold pressor test (time frame: Continuous measurement of vascular conductance during cold pressor test (final 2 min of normoxia and hypoxia).). 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 28 Jul 2026.