COMPLETED

Sex Hormone and Vascular Function in Women With CKD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sex Hormone and Vascular Function in Women With CKD

Quick Facts

Study Start:2021-07-01
Study Completion:2024-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05471518

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pre- (18-44 y) and post-menopausal (55-75 y) women
  2. 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. 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).
  1. 1. Perimenopausal (45-54 y) women
  2. 2. Pregnancy, lactation, or less than one year post-partum
  3. 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. 4. Advanced CKD requiring dialysis
  5. 5. History of kidney transplant
  6. 6. Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease in CKD group)
  7. 7. Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
  8. 8. Current tobacco or nicotine use or history of use in the last 12 months
  9. 9. Marijuana use within 2 weeks prior to testing
  10. 10. Uncontrolled hypertension in CKD group (BP \>140/90 mmHg)
  11. 11. Atrial fibrillation
  12. 12. Active infection or antibiotic therapy
  13. 13. Hospitalization in the last month

Contacts and Locations

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2024-11-30

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2024-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases