Clinical trial

Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Name

2022525

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.

Trial arms

Trial start

2020-12-09

Estimated PCD

2025-06-30

Trial end

2025-06-30

Status

Recruiting

Phase

Early phase I

Treatment

Hypoxia Exposure

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

Arms:

Hypoxia Exposure

Phenylephrine

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

Arms:

Hypoxia Exposure

Other names:

Phenylephrine Hydrochloride

Dexmedetomidine

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

Arms:

Hypoxia Exposure

Phentolamine

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.

Arms:

Hypoxia Exposure

Other names:

Phentolamine mesylate

Norepinephrine

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

Arms:

Hypoxia Exposure

Size

104

Primary endpoint

Change in forearm vascular conductance with intra-arterial drug infusion

Continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}

Updated at

2024-05-03

1 organization

4 products

4 indications

Organization

University of Missouri-Columbia

Product

Phenylephrine

Indication

Obesity

Indication