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Completed

NCT Number: NCT05471518

Sex Hormone and Vascular Function in Women With CKD

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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) ≥ 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).

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)
  • Atrial fibrillation
  • Active infection or antibiotic therapy
  • Hospitalization in the last month

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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

  1. Carotid Femoral Pulse Wave Velocity

    Time frame: Baseline

    A transcutaneous custom tonometer [Noninvasive Hemodynamics Workstation (NIHem), Cardiovascular Engineering Inc.] will be used to non-invasively assess carotid femoral pulse wave velocity.

  2. Serum Sex Hormones

    Time frame: 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.

  3. Urinary Sex Hormones

    Time frame: 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.

Other outcomes

  1. Circulating/Urinary Markers of Antioxidant Status/Oxidative stress

    Time frame: Baseline

    Serum TAS, plasma/urinary 8-isoprostane, 8-OHdG will be measured using ELISA.

  2. Circulating Markers of Inflammation

    Time frame: Baseline

    Plasma CRP, IL-1β, IL-6, and TNF-α will be measured using ELISA

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

    Time frame: Baseline

    PBMCs will be isolated from heparinized whole blood using Cell Preparation Tube, PBMCs will be cultured with LPS, and supernatants will be harvested after 4-hour stimulation at 37°C. IL-1β, IL-6, and TNF-α in the supernatants will be measured using ELISA.

  4. Distribution of Monocyte Subsets

    Time frame: Baseline

    PBMCs will be stained with fluorescence-labeled antibodies for monocyte (CD14 and CD16) and analyzed using an LSR II flow cytometer.

  5. Ex Vivo Nitric Oxide Production from Human Umbilical Vein Endothelial Cells (HUVECs)

    Time frame: Baseline

    HUVECs will be incubated with basal media supplemented with 10% human serum collected from participants and stained with the fluorescent probe DAF-FM diacetate to detect nitric oxide production production in response to acetylcholine.

  6. Ex Vivo Reactive Oxygen Species Production from Human Umbilical Vein Endothelial Cells (HUVECs)

    Time frame: Baseline

    HUVECs will be incubated with basal media supplemented with 10% human serum collected from participants and stained with the fluorescent probe DAF-FM diacetate to detect reactive oxygen species production in response to acetylcholine.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2022
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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