Understanding how obesity affects women's cardiovascular response to low oxygen
Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
This study is trying to see how obesity affects women's heart response to low oxygen levels compared to men, especially in people with sleep apnea.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT04436731 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in cardiovascular responses to low oxygen levels between men and women, particularly focusing on the impact of obesity. It aims to explore the mechanisms behind these sex disparities, especially in the context of patients with sleep apnea, a condition that significantly increases cardiovascular risk. The study involves interventions such as hypoxia exposure and various pharmacological agents to assess their effects on vasoconstriction and vasodilation. By enhancing our understanding of these mechanisms, the research hopes to improve existing therapies and pave the way for new treatment options.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women aged 18-45 who are either healthy weight or obese.
Not a fit: Patients with diagnosed sleep apnea or significant cardiovascular, hepatic, renal, or respiratory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for women with obesity and sleep apnea, reducing their cardiovascular risk.
How similar studies have performed: While there is ongoing research into sex differences in cardiovascular responses, this specific approach focusing on obesity and hypoxia in women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbia, Missouri
- University of Missouri-Columbia — Columbia, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Jacqueline K Limberg, Ph.D.
- Email: limbergj@missouri.edu
- Phone: 573-882-2544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.