Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

NCT ID: NCT04436731

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Healthy Vasoconstriction Vasodilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hypoxia Exposure

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).

Group Type EXPERIMENTAL

Hypoxia Exposure

Intervention Type OTHER

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

Phenylephrine

Intervention Type DRUG

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

Dexmedetomidine

Intervention Type DRUG

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

Phentolamine

Intervention Type DRUG

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.

Norepinephrine

Intervention Type DRUG

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

Interventions

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Hypoxia Exposure

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

Intervention Type OTHER

Phenylephrine

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

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.

Intervention Type DRUG

Norepinephrine

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

Intervention Type DRUG

Other Intervention Names

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Phenylephrine Hydrochloride Phentolamine mesylate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jacqueline K Limberg, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Missouri-Columbia

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2022525

Identifier Type: -

Identifier Source: org_study_id

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