Sex Hormone and Vascular Function in Women With CKD
- Conditions
- Chronic Kidney Diseases
- Registration Number
- NCT05471518
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria:<br><br> 1. Pre- (18-44 y) and post-menopausal (55-75 y) women<br><br> 2. Individuals with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by<br> the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation AND/OR<br> urinary albumin-creatinine ratio (UACR) = 30.<br><br> 3. Controls must be healthy (free from hypertension, kidney disease, cardiovascular<br> disease, diabetes, and other chronic disease as assessed by self-report, medical<br> history, and screening labs). Premenopausal healthy women must have a regular<br> menstrual cycle (25-35 d).<br><br>Exclusion Criteria:<br><br> 1. Perimenopausal (45-54 y) women<br><br> 2. Pregnancy, lactation, or less than one year post-partum<br><br> 3. Use of hormonal birth control methods, hormone replacement therapy, or a<br> levonorgestrel intrauterine device (IUD) insertion for a duration less than 6 months<br><br> 4. Advanced CKD requiring dialysis<br><br> 5. History of kidney transplant<br><br> 6. Use of immunosuppressant medications (unless taking a stable dosage for a quiescent<br> disease in CKD group)<br><br> 7. Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing<br><br> 8. Current tobacco or nicotine use or history of use in the last 12 months<br><br> 9. Marijuana use within 2 weeks prior to testing<br><br> 10. Uncontrolled hypertension in CKD group (BP >140/90 mmHg)<br><br> 11. Atrial fibrillation<br><br> 12. Active infection or antibiotic therapy<br><br> 13. Hospitalization in the last month
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brachial Artery Flow-Mediated Dilation
- Secondary Outcome Measures
Name Time Method Carotid Femoral Pulse Wave Velocity;Serum Sex Hormones;Urinary Sex Hormones