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NCT05219799 Clinical Trial

Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

Healthy Clinical Trial

Official title:
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05219799
Other study ID # 2080504
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 14, 2023
Est. completion date July 2025

Study information
Verified date February 2024
Source University of Missouri-Columbia
Contact Jacqueline K Limberg, Ph.D.
Phone 5738822544
Email limbergj@missouri.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 72
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propranolol Hydrochloride
Regional forearm blockade of ß-adrenergic receptors at 20 mcg/dL/min via brachial artery catheter during normoxia and hypoxia exposures
• Isoproterenol
Dose response (1, 3, 6, and 12 ng/dL/min) regional infusion to assess ß-adrenergic receptor responsiveness
• Phentolamine Mesylate
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
Regional forearm infusion at 8 ng/dL/min via brachial artery catheter during normoxia and hypoxia exposures

Locations
Country Name City State
United States University of Missouri Columbia Missouri

Sponsors (1)
Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in forearm vascular conductance with intra-arterial drug infusion Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography. Change from baseline to last 1-minute of drug infusion
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