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NCT Number: NCT05219799

Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

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.

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Key information

Conditions

Obesity Aneurysm Body Weight Cardiovascular Diseases Healthy Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vasodilation

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

Location status: Recruiting

Location contact

Jennifer L Harper

CONTACT

[email protected]

5738822544

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol Hydrochloride

Drug

Regional forearm blockade of β-adrenergic receptors at 20 mcg/dL/min via brachial artery catheter during normoxia and hypoxia exposures

Isoproterenol

Drug

Dose response (1, 3, 6, and 12 ng/dL/min) regional infusion to assess β-adrenergic receptor responsiveness

Phentolamine Mesylate

Drug

This infusion will be for 10 min before baseline measurement (12 mcg/dL/min) and continue the infusion at a maintenance rate (5 mcg/dL/min).

norepinephrine

Drug

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

Primary outcomes

  1. Change in forearm vascular conductance with intra-arterial drug infusion

    Time frame: Change from baseline to last 1-minute of drug infusion

    Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline K Limberg, Ph.D.

CONTACT

[email protected]

5738822544

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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