Sex Hormone and Vascular Function in Women With CKD

NCT ID: NCT05471518

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-11-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pre-menopausal women with CKD

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

No intervention

Intervention Type: OTHER

No intervention

Post-menopausal women with CKD

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

No intervention

Intervention Type: OTHER

No intervention

Pre-menopausal healthy women

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

No intervention

Intervention Type: OTHER

No intervention

Post-menopausal healthy women

Age 55-75 years

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

21-3018

Identifier Type: -

Identifier Source: org_study_id