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Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04436731
Enrollment
104
Registered
2020-06-18
Start date
2020-12-09
Completion date
2026-06-30
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Healthy, Vasoconstriction, Vasodilation

Brief 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 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.

Interventions

Systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.

DRUGPhenylephrine

Phenylephrine (0.0625 mcg/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.

DRUGDexmedetomidine

Dexmedetomidine (12.5 ng/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.

Phentolamine will be locally infused via brachial artery catheter for 10 min before baseline measurement (12 mcg/dL/min) and the infusion will continue at a maintenance rate (5 mcg/dL/min) during acute normoxia and hypoxia.

DRUGNorepinephrine

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

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-45 years of age (premenopausal) * Healthy weight (BMI ≥18 and ≤25 kg/m2) * Obese (BMI ≥30 kg/m2)

Exclusion criteria

* 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 * Blood pressure ≥140/90 mmHg * Diabetes, Polycystic ovarian syndrome * Communication barriers * Prescription medications, Sensitivity to lidocaine

Design outcomes

Primary

MeasureTime frameDescription
Change in forearm vascular conductance with intra-arterial drug infusionContinuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026