ClinicalTrials.gg
RecruitingNCT05219799Updated Jul 28, 2026

Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

An Early Phase 1 interventional study of Propranolol Hydrochloride and Isoproterenol in Obesity, Vasodilation and Healthy, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by University of Missouri-Columbia · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The purpose of this project is to examine key mechanisms contributing to sex-differences in hypoxic vasodilation and the impact of obesity, with particular emphasis on the sympathetic nervous system.

Read the detailed description

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.

02

Conditions studied

  • Obesity
  • Vasodilation
  • Healthy
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 72 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.

Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >18 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, breastfeeding
  • Diagnosed sleep apnea or AHI >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
  • Blood pressure ≥140/90 mmHg
  • Diabetes, Polycystic ovarian syndrome
  • Communication barriers
  • Prescription medications, Sensitivity to lidocaine
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Other
    Hypoxia Exposure

    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.

    Drug: Propranolol Hydrochloride · Drug: Isoproterenol · Drug: Phentolamine Mesylate · Drug: Norepinephrine

Interventions

  • Regional forearm blockade of β-adrenergic receptors at 20 mcg/dL/min via brachial artery catheter during normoxia and hypoxia exposures

  • Dose response (1, 3, 6, and 12 ng/dL/min) regional infusion to assess β-adrenergic receptor responsiveness

  • This infusion will be for 10 min before baseline measurement (12 mcg/dL/min) and continue the infusion at a maintenance rate (5 mcg/dL/min).

  • Regional forearm infusion at 8 ng/dL/min via brachial artery catheter during normoxia and hypoxia exposures

06

What researchers measure

Primary outcomes

  1. Change in forearm vascular conductance with intra-arterial drug infusion

    Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.

    Time frame: Change from baseline to last 1-minute of drug infusion

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Jul 2027, 52 months after the start.

Of 105 non-industry phase 1 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's planned 52 months is above that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2022
First posted
Feb 2, 2022
StartActual
Mar 14, 2023
Primary completionEst.
Jul 30, 2027
CompletionEst.
Jul 30, 2027
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05219799
Responsible party
Jacqueline K Limberg, PhD (Assistant Professor, University of Missouri-Columbia) — Principal investigator
First posted
Feb 2, 2022
Start date
Mar 14, 2023
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Jul 28, 2026

Study contacts

Jacqueline K Limberg, Ph.D.
Contact
limbergj@missouri.edu
5738822544
Jacqueline Limberg, Ph.D.
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Propranolol · Isoproterenol · Phentolamine · Norepinephrine

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