Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

NCT04436731 | Completed Early Phase 1 DMC

• 1 other identifier: 2022525
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Healthy; Vasoconstriction; Vasodilation

Outcome Measures

Primary Outcomes (1)

• Change in forearm vascular conductance with cold pressor test

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

  Continuous measurement of vascular conductance during cold pressor test (final 2 min of normoxia and hypoxia).

Study Arms (1)

Hypoxia Exposure

EXPERIMENTAL

Participants will undergo room air (normoxic) and low oxygen (hypoxic) conditions.

Other: Cold Pressor Test

Interventions

Cold Pressor Test OTHER

Participants will complete the cold pressor test during the final 2 min of normoxia and hypoxia.

Hypoxia Exposure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age (premenopausal)
• Healthy weight (BMI ≥18 and ≤25 kg/m2)
• Obese (BMI ≥30 kg/m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Obesity; Aneurysm

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 18, 2020
• Study Start: December 9, 2020
• Primary Completion: July 2, 2026
• Study Completion: July 2, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)