Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Healthy Clinical Trial

Official title:

Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436731
• Other study ID #: 2022525
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 9, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Jacqueline K Limberg, Ph.D.
• Phone: 573-882-2544
• Email: limbergj[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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: 104
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Obesity
• Vasoconstriction
• Vasodilation

Intervention

Other:
• Hypoxia Exposure
Systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	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.	Continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).