Sex Hormone and Vascular Function in Women With CKD

NCT05471518 | Completed

• 1 other identifier: 21-3018
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Carotid Femoral Pulse Wave Velocity

  Baseline

• Serum Sex Hormones

  Baseline

• Urinary Sex Hormones

  Baseline

Other Outcomes (6)

• Circulating/Urinary Markers of Antioxidant Status/Oxidative stress

  Baseline

• Circulating Markers of Inflammation

  Baseline

• Cytokine secretion from lipopolysaccharide(LPS)-stimulated peripheral blood mononuclear cells (PBMCs)

  Baseline

Study Arms (4)

Pre-menopausal women with CKD

Age 18-44 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2)

Other: No intervention

Post-menopausal women with CKD

Age 55-75 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2)

Other: No intervention

Pre-menopausal healthy women

Age 18-44 years Regular menstrual cycle (25-35 d)

Other: No intervention

Post-menopausal healthy women

Age 55-75 years

Other: No intervention

Interventions

No intervention OTHER

No intervention

Post-menopausal healthy women; Post-menopausal women with CKD; Pre-menopausal healthy women; Pre-menopausal women with CKD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre- and post-menopausal women with CKD vs. age-matched healthy women

You may qualify if:

• 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) ≥ 30.
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: July 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)