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Clinical Trials/NCT05471518
NCT05471518
Completed
Not Applicable

Sex Hormone and Vascular Function in Women With CKD

University of Colorado, Denver1 site in 1 country51 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University of Colorado, Denver
Enrollment
51
Locations
1
Primary Endpoint
Brachial Artery Flow-Mediated Dilation
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
November 30, 2024
Last Updated
7 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 AND/OR urinary albumin-creatinine ratio (UACR) ≥
  • 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)

Outcomes

Primary Outcomes

Brachial Artery Flow-Mediated Dilation

Time Frame: Baseline

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.

Secondary Outcomes

  • Serum Sex Hormones(Baseline)
  • Carotid Femoral Pulse Wave Velocity(Baseline)
  • Urinary Sex Hormones(Baseline)

Study Sites (1)

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