Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propranolol Hydrochloride, Isoproterenol, Phentolamine Mesylate, Norepinephrine.
- Who it may be relevant to
- Registry conditions: Obesity, Vasodilation, Healthy. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this project is to examine key mechanisms contributing to sex-differences in hypoxic vasodilation and the impact of obesity, with particular emphasis on the sympathetic nervous system.
Detailed description
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.
Interventions
- Drug Propranolol Hydrochloride
Regional forearm blockade of β-adrenergic receptors at 20 mcg/dL/min via brachial artery catheter during normoxia and hypoxia exposures - Drug Isoproterenol
Dose response (1, 3, 6, and 12 ng/dL/min) regional infusion to assess β-adrenergic receptor responsiveness - Drug Phentolamine Mesylate
This infusion will be for 10 min before baseline measurement (12 mcg/dL/min) and continue the infusion at a maintenance rate (5 mcg/dL/min). - Drug Norepinephrine
Regional forearm infusion at 8 ng/dL/min via brachial artery catheter during normoxia and hypoxia exposures
Primary outcome measures
- Change in forearm vascular conductance with intra-arterial drug infusion [Time frame: Change from baseline to last 1-minute of drug infusion]
Eligibility criteria
Inclusion criteria
- BMI >18 kg/m2
Exclusion criteria
- Pregnancy, breastfeeding
- Diagnosed sleep apnea or AHI >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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Missouri — Columbia
Identifiers
NCT: NCT05219799 · 2080504