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Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease

Sponsor
University of Calgary (Other)
Overall Status
Completed
CT.gov ID
NCT06107166
Collaborator
(none)
61
Enrollment
1
Location
43
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    61 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease
    Actual Study Start Date :
    Jun 1, 2018
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Pulse wave velocity [Measured at baseline]

    2. Aortic augmentation index [Measured at baseline]

    3. Flow mediated dilation [Measured at baseline]

    4. Velocity time integral [Measured at baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 51 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • female sex

    • a diagnosis of chronic kidney disease or end stage kidney disease

    • age 18-51

    Exclusion Criteria:

    Pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Calgary Calgary Alberta Canada T2N1N4

    Sponsors and Collaborators

    • University of Calgary

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sandra Dumanski, Assistant Professor, University of Calgary
    ClinicalTrials.gov Identifier:
    NCT06107166
    Other Study ID Numbers:
    • REB18-0642
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Oct 30, 2023