Sex Hormone and Vascular Function in Women With CKD

Recruiting

• Conditions: Chronic Kidney Diseases
• Interventions: Other: No intervention

• Registration Number: NCT05471518
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-menopausal healthy women	No intervention	Age 18-44 years Regular menstrual cycle (25-35 d)
Pre-menopausal women with CKD	No intervention	Age 18-44 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2)
Post-menopausal women with CKD	No intervention	Age 55-75 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2)
Post-menopausal healthy women	No intervention	Age 55-75 years

Primary Outcome Measures

Name	Time	Method
Brachial Artery Flow-Mediated Dilation	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 Outcome Measures

Name	Time	Method
Serum Sex Hormones	Baseline	Serum sex hormones \[follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, sex hormone binding globulin (SHBG), and anti-mullerian hormone (AMH)\] will be measured using chemiluminescent assays.
Carotid Femoral Pulse Wave Velocity	Baseline	A transcutaneous custom tonometer \[Noninvasive Hemodynamics Workstation (NIHem), Cardiovascular Engineering Inc.\] will be used to non-invasively assess carotid femoral pulse wave velocity.
Urinary Sex Hormones	Baseline	Urinary sex hormones \[follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrone-3-glucuronide (E1c), and pregnanediol-3-glucuronide (Pdg)\] will be measured by by chemiluminescent assays using ACS-180 Autoanalyzer.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States