Sex Hormone and Vascular Function in Women With CKD

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05471518

21-3018

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

51 participants in 4 patient groups

Pre-menopausal women with CKD

Description:

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

Treatment:

Other: No intervention

Post-menopausal women with CKD

Description:

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

Treatment:

Other: No intervention

Pre-menopausal healthy women

Description:

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

Treatment:

Other: No intervention

Post-menopausal healthy women

Description:

Age 55-75 years

Treatment:

Other: No intervention