Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

University of Missouri (MU)

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy; Vasodilation; Obesity

Treatments: Drug: Isoproterenol; Drug: Norepinephrine; Drug: Propranolol Hydrochloride; Drug: Phentolamine Mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05219799

2080504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI >18 kg/m2

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Hypoxia Exposure

Other group

Description:

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.

Treatment:

Drug: Phentolamine Mesylate

Drug: Propranolol Hydrochloride

Drug: Norepinephrine

Drug: Isoproterenol