Sex Hormone and Vascular Function in Women With CKD

Study Overview
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Brief Summary
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The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in the field of nephrology focuses on male patients, and studies on women's vascular health are limited. Moreover, endogenous sex hormones, particularly estradiol, are well-documented to be cardioprotective in women without CKD; however, the role of sex hormones on vascular function in women with CKD remains unclear. The goals of the proposed project are: 1) to evaluate vasuclar function in pre- and post-menopausal women with CKD vs. age-matched healthy women; 2) to evaluate sex hormone concentrations and determine whether they associate with vascular function in the proposed cohort; and 3) to gain mechanistic insight on the association between sex hormones and vascular dysfunction in the proposed cohort.

Official Title
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Sex Hormone and Vascular Function in Women With CKD

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre- (18-44 y) and post-menopausal (55-75 y) women 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 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: Perimenopausal (45-54 y) women Pregnancy, lactation, or less than one year post-partum Use of hormonal birth control methods, hormone replacement therapy, or a levonorgestrel intrauterine device (IUD) insertion for a duration less than 6 months Advanced CKD requiring dialysis History of kidney transplant Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease in CKD group) Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing Current tobacco or nicotine use or history of use in the last 12 months Marijuana use within 2 weeks prior to testing Uncontrolled hypertension in CKD group (BP >140/90 mmHg) Atrial fibrillation Active infection or antibiotic therapy Hospitalization in the last month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-menopausal women with CKD<br>Age 18-44 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2) | Other: No intervention<br>* No intervention<br>|
| Post-menopausal women with CKD<br>Age 55-75 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2) | Other: No intervention<br>* No intervention<br>|
| Pre-menopausal healthy women<br>Age 18-44 years Regular menstrual cycle (25-35 d) | Other: No intervention<br>* No intervention<br>|
| Post-menopausal healthy women<br>Age 55-75 years | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial Artery Flow-Mediated Dilation | Flow-mediated dilation of the brachial artery will be performed using ultrasonography and analyzed with a commercially available software package as percent change in diameter from baseline following reactive hyperemia. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid Femoral Pulse Wave Velocity | A transcutaneous custom tonometer [Noninvasive Hemodynamics Workstation (NIHem), Cardiovascular Engineering Inc.] will be used to non-invasively assess carotid femoral pulse wave velocity. | Baseline | 
| Serum Sex Hormones | Serum sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, sex hormone binding globulin (SHBG), and anti-mullerian hormone (AMH)] will be measured using chemiluminescent assays. | Baseline | 
| Urinary Sex Hormones | Urinary sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrone-3-glucuronide (E1c), and pregnanediol-3-glucuronide (Pdg)] will be measured by by chemiluminescent assays using ACS-180 Autoanalyzer. | Baseline |