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OpenTrials
Completed

NCT Number: NCT05195164

The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women

This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.

Completed

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Key information

About this study

The global aim of this study is to characterize cardiometabolic risk (measured by vascular, metabolic and biochemical factors-which have not been extensively studied prospectively) in trans women before and after orchiectomy. Trans women appear to be at greater risk for cardiovascular disease (CVD) and blood clots compared to non-trans adults. The effect of orchiectomy on CVD risk among trans women is unknown, but orchiectomy may change blood vessel function and metabolic health. The investigators will examine blood vessel function and metabolic profiles of trans women before and at several timepoints after orchiectomy to identify age-related differences in CVD risk factors. This knowledge may lead to new approaches to prevent CVD in trans women as well as all people regardless of gender identity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 years and older
  • Identify as a transgender woman
  • Have taken estradiol and spironolactone for at least one year
  • Currently taking oral or transdermal or injectable estradiol
  • Have not yet undergone but desire orchiectomy

Exclusion criteria

  • Under 18 years of age
  • Don't identify as a transgender woman
  • Not currently taking estradiol or spironolactone
  • Have been on estradiol and spironolactone for less than one year
  • History of orchiectomy
  • Not deemed a candidate for orchiectomy
  • Current tobacco smoker
  • Current illicit drug use
  • History of prior or active estrogen-dependent neoplasms
  • Acute liver or gallbladder disease
  • Venous thromboembolism
  • Hypertriglyceridemia >500 mg/dL
  • Fasted plasma glucose >7.0 mmol/L or previously treated diabetes
  • Resting blood pressure >140/90 mmHg

Treatment and study plan

No intervention

Other

There was no intervention

Primary outcomes

  1. Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline

    Time frame: Baseline

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

  2. Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month

    Time frame: 1 month

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

  3. Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months

    Time frame: 6 month

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

  4. Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months

    Time frame: 12 month

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

Secondary outcomes

  1. Evaluation of carotid artery compliance

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    The carotid artery compliance index indicates how elastic the artery is. The index describes the change in arterial blood volume in response to a change in arterial blood pressure. Lower numbers are associated with worse outcomes (less elastic arteries).

  2. Evaluation of carotid artery beta stiffness index

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    The carotid artery beta stiffness index indicates how stiff the artery is. Higher numbers are associated with worse outcomes (stiffer artery).

  3. Carotid artery intimal-medial thickness

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

  4. Evaluation of oxidant burden: oxidized LDL

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.

  5. Evaluation of oxidant burden: nitrotyrosine

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Nitrotyrosine measured in the blood and endothelial cells.

  6. Evaluation of vascular endothelial cell inflammation: nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB)

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.

  7. Evaluation of vascular endothelial cell inflammation: MCP-1

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.

  8. Evaluation of vascular endothelial cell inflammation: IL-6

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Interleukin 6 (IL-6) measured in blood and endothelial cells.

  9. Evaluation of vascular endothelial cell inflammation: CRP

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    C-reactive protein (CRP) measured in blood and endothelial cells.

  10. Blood pressure

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Blood pressure will be measured at baseline, 1 mo., 6 mo. 12 mo.

  11. Plasma lipid concentrations: total cholesterol

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Total cholesterol will be determined at baseline, 1 mo., 6 mo., 12 mo.

  12. Plasma lipid concentrations: triglycerides

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Triglycerides will be determined at baseline, 1 mo., 6 mo., 12 mo.

  13. Insulin sensitivity

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

  14. Whole body composition: Percent Lean Mass

    Time frame: Baseline, 6 mo., 12 mo.

    Percent lean mass will be determined using dual energy x-ray absorptiometry.

  15. Whole body composition: Percent Fat Mass

    Time frame: Baseline, 6 mo., 12 mo.

    Percent fat mass will be determined using dual energy x-ray absorptiometry.

  16. Regional body composition: Percent Lean Mass

    Time frame: Baseline, 6 mo., 12 mo.

    Regional percent lean mass will be determined using dual energy x-ray absorptiometry.

  17. Regional body composition: Percent Fat Mass

    Time frame: Baseline, 6 mo., 12 mo.

    Regional percent fat mass will be determined using dual energy x-ray absorptiometry.

  18. Bone density

    Time frame: Baseline, 12 mo.

    Bone density of femur and spine will be determined using dual energy x-ray absorptiometry.

  19. Weight changes

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Body weight will be measured at baseline, 1 mo., 6 mo., 12 mo.

  20. Appetite ratings

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

  21. Appetite-related peptides

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

  22. D-Dimer

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

  23. Alcohol use

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

  24. Depression symptoms

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

  25. Physical activity monitoring

    Time frame: 7 days at baseline, 1 mo., 6 mo., 12 mo.

    Physical activity will me monitored for 7 days with an ActivPAL monitor

  26. Energy intake

    Time frame: 3 days at baseline, 1 mo., 6 mo., 12 mo.

    Energy intake will be estimated with a 3-day food diary

  27. Sex hormone concentrations

    Time frame: Baseline, 1 mo., 6 mo., 12 mo.

    Sex hormone concentrations of estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH) and sex hormone-binding globulin (SHBG) will be measured

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2022
Registry last updated
Sep 19, 2024

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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