Clinical trial NCT05471518: Sex Hormone and Vascular Function in Women With CKD
Official title: Sex Hormone and Vascular Function in Women With CKD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre- and post-menopausal women with CKD vs. age-matched healthy women

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Brachial Artery Flow-Mediated Dilation
timeFrame: Baseline
Secondary outcomes:
measure: Carotid Femoral Pulse Wave Velocity
timeFrame: Baseline
measure: Serum Sex Hormones
timeFrame: Baseline
measure: Urinary Sex Hormones
timeFrame: Baseline
Other outcomes:
measure: Circulating/Urinary Markers of Antioxidant Status/Oxidative stress
timeFrame: Baseline
measure: Circulating Markers of Inflammation
timeFrame: Baseline
measure: Cytokine secretion from lipopolysaccharide(LPS)-stimulated peripheral blood mononuclear cells (PBMCs)
timeFrame: Baseline
measure: Distribution of Monocyte Subsets
timeFrame: Baseline
measure: Ex Vivo Nitric Oxide Production from Human Umbilical Vein Endothelial Cells (HUVECs)
timeFrame: Baseline
measure: Ex Vivo Reactive Oxygen Species Production from Human Umbilical Vein Endothelial Cells (HUVECs)
timeFrame: Baseline
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References: