Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia

The purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Vasodilation
• Intervention / Treatment: Drug: Placebo; Drug: Propranolol Pill

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jacqueline K Limberg, Ph.D.; Phone Number: 5738822455; Email: limbergj@missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Recruiting
      • University of Missouri-Columbia
      • Contact: Jennifer Harper, BS; Phone Number: 573-882-2544; Email: harperjl@missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy adult men and women;
• 18-45 years of age;
• BMI 18-30 kg/m2;
• non-pregnant/non-breastfeeding;
• non-nicotine users;

Exclusion Criteria:

• Pregnancy, breastfeeding, hormonal contraceptives
• Diagnosed sleep apnea
• Current smoking/Nicotine use/drug use
• Nerve/neurologic disease
• Cardiovascular, hepatic, renal, respiratory disease
• Blood pressure ≥140/90 mmHg
• Diabetes, Polycystic ovarian syndrome
• Communication barriers
• Prescription medications
• Recent COVID-19 diagnosis with symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypoxia Exposure; Men and women will be exposed to isocapnic hypoxia. Participants will wear a mask and systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.	Drug: Placebo; Participants will receive a placebo in pill form.; Drug: Propranolol Pill; Participants will receive a β-blockade (propranolol pill, 1 mg/kg dosed based on participant weight).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forearm Blood Flow	Measured with venous occlusion plethysmography (mL/dL/min)	Change from baseline to 5 minutes

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Jacqueline K Limberg, Ph.D., University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 2087402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No