Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
Primary Purpose
Vasodilation, Hypoxia
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Propranolol Pill
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Vasodilation
Eligibility Criteria
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
Sites / Locations
- University of Missouri-ColumbiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypoxia Exposure
Arm Description
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.
Outcomes
Primary Outcome Measures
Forearm Blood Flow
Measured with venous occlusion plethysmography (mL/dL/min)
Secondary Outcome Measures
Full Information
NCT ID
NCT05256069
First Posted
February 14, 2022
Last Updated
July 12, 2023
Sponsor
University of Missouri-Columbia
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT05256069
Brief Title
Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
Official Title
Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasodilation, Hypoxia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypoxia Exposure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Propranolol Pill
Intervention Description
Participants will receive a β-blockade (propranolol pill, 1 mg/kg dosed based on participant weight).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a placebo in pill form.
Primary Outcome Measure Information:
Title
Forearm Blood Flow
Description
Measured with venous occlusion plethysmography (mL/dL/min)
Time Frame
Change from baseline to 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Harper, B.S.
Phone
5738822455
Email
harperjl@missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline K Limberg, Ph.D.
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Harper, BS
Phone
573-882-2544
Email
harperjl@missouri.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
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