Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
NCT ID: NCT04436731
Last Updated: 2025-06-04
Study Results
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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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
104 participants
INTERVENTIONAL
2020-12-09
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
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).
Hypoxia Exposure
Systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.
Phenylephrine
Phenylephrine (0.0625 mcg/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
Dexmedetomidine
Dexmedetomidine (12.5 ng/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
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.
Norepinephrine
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.
Phenylephrine
Phenylephrine (0.0625 mcg/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
Dexmedetomidine
Dexmedetomidine (12.5 ng/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
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.
Norepinephrine
Regional forearm infusion at 8 ng/dL/min via brachial artery catheter during normoxia and hypoxia exposures
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy weight (BMI ≥18 and ≤25 kg/m2)
* Obese (BMI ≥30 kg/m2)
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Jacqueline K Limberg, PhD
Assistant Professor
Locations
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University of Missouri-Columbia
Columbia, Missouri, United States
Countries
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Other Identifiers
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2022525
Identifier Type: -
Identifier Source: org_study_id
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