Investigating sex hormones and vascular health in women with chronic kidney disease
Sex Hormone and Vascular Function in Women With CKD
This study is trying to see how sex hormones affect blood vessel health in women with chronic kidney disease compared to healthy women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05471518 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate vascular function in pre- and post-menopausal women with chronic kidney disease (CKD) compared to age-matched healthy women. It will assess sex hormone concentrations, particularly estradiol, and their association with vascular function in this population. The study seeks to fill a gap in nephrology literature by focusing on women's health, as most existing research has predominantly centered on male patients. By understanding the role of sex hormones in vascular dysfunction, the study hopes to provide insights into cardiovascular risks in women with CKD.
Who should consider this trial
Good fit: Ideal candidates include pre-menopausal women aged 18-44 and post-menopausal women aged 55-75 with stage 3-4 CKD.
Not a fit: Patients who are perimenopausal, pregnant, or have advanced CKD requiring dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cardiovascular risks in women with CKD and inform targeted interventions.
How similar studies have performed: While there is limited research specifically on women with CKD, studies on sex hormones and cardiovascular health in other populations suggest potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pre- (18-44 y) and post-menopausal (55-75 y) women 2. Individuals with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation AND/OR urinary albumin-creatinine ratio (UACR) ≥ 30. 3. Controls must be healthy (free from hypertension, kidney disease, cardiovascular disease, diabetes, and other chronic disease as assessed by self-report, medical history, and screening labs). Premenopausal healthy women must have a regular menstrual cycle (25-35 d). Exclusion Criteria: 1. Perimenopausal (45-54 y) women 2. Pregnancy, lactation, or less than one year post-partum 3. Use of hormonal birth control methods, hormone replacement therapy, or a levonorgestrel intrauterine device (IUD) insertion for a duration less than 6 months 4. Advanced CKD requiring dialysis 5. History of kidney transplant 6. Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease in CKD group) 7. Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing 8. Current tobacco or nicotine use or history of use in the last 12 months 9. Marijuana use within 2 weeks prior to testing 10. Uncontrolled hypertension in CKD group (BP \>140/90 mmHg) 11. Atrial fibrillation 12. Active infection or antibiotic therapy 13. Hospitalization in the last month
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Ester S Oh, Ph.D.
- Email: ester.oh@cuanschutz.edu
- Phone: 303-724-3765
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.