Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

University of Missouri (MU)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Healthy; Vasodilation; Obesity; Vasoconstriction

Treatments: Drug: Dexmedetomidine; Other: Hypoxia Exposure; Drug: Phentolamine; Drug: Phenylephrine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04436731

2022525

Details and patient eligibility

About

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: 104 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Hypoxia Exposure

Experimental group

Description:

A physician will place a catheter in the brachial artery for intra-arterial pharmacological infusions. The following drugs will be administered to each participant under room air (normoxic) and low oxygen (hypoxic) conditions: phenylephrine, dexmedetomidine, norepinephrine, phentolamine (see Interventions for details).

Treatment:

Drug: Norepinephrine

Drug: Phenylephrine

Drug: Phentolamine

Other: Hypoxia Exposure

Drug: Dexmedetomidine