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Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Primary Purpose

Obesity, Healthy, Vasoconstriction

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hypoxia Exposure
Phenylephrine
Dexmedetomidine
Phentolamine
Norepinephrine
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Missouri-ColumbiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypoxia Exposure

Arm Description

A physician will place a catheter in the brachial artery for intra-arterial pharmacological infusions. The following drugs will be administered to each participant under room air (normoxic) and low oxygen (hypoxic) conditions: phenylephrine, dexmedetomidine, norepinephrine, phentolamine (see Interventions for details).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2020
Last Updated
April 3, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04436731
Brief Title
Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
Official Title
Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Healthy, Vasoconstriction, Vasodilation

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
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoxia Exposure
Arm Type
Experimental
Arm Description
A physician will place a catheter in the brachial artery for intra-arterial pharmacological infusions. The following drugs will be administered to each participant under room air (normoxic) and low oxygen (hypoxic) conditions: phenylephrine, dexmedetomidine, norepinephrine, phentolamine (see Interventions for details).
Intervention Type
Other
Intervention Name(s)
Hypoxia Exposure
Intervention Description
Systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Phenylephrine Hydrochloride
Intervention Description
Phenylephrine (0.0625 mcg/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine (12.5 ng/dL/min) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
Intervention Type
Drug
Intervention Name(s)
Phentolamine
Other Intervention Name(s)
Phentolamine mesylate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Regional forearm infusion at 8 ng/dL/min via brachial artery catheter during normoxia and hypoxia exposures
Primary Outcome Measure Information:
Title
Change in forearm vascular conductance with intra-arterial drug infusion
Description
Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.
Time Frame
Continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Harper, B.S.
Phone
573-882-2544
Email
harperjl@missouri.edu
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
Jacqueline K Limberg, Ph.D.
Phone
573-882-2420
Email
limbergj@missouri.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

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