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Completed

NCT Number: NCT04237467

Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men

This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in older versus younger transgender men (people who were assigned female at birth but whose gender identity is male). Data will also be compared to those from age group-matched transgender women and cisgender women and men.

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Key information

Conditions

Transgender Appetitive Behavior Behavior Behavior, Animal Blood Pressure Gender Identity Lipid Disorder Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Inflammation Vascular Stiffness

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-40 years old or 50-75 years old
  • Identify as a transgender woman
  • Have taken testosterone for at least one year
  • Currently taking testosterone parenterally (injections) or transdermally (patches or gels)

Exclusion criteria

  • Don't identify as a transgender man
  • Not currently taking testosterone
  • Have been on testosterone for less than one year
  • History of hysterectomy/oophorectomy
  • 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)

    Time frame: Baseline

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

Secondary outcomes

  1. Evaluation of carotid artery compliance

    Time frame: Baseline

    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

    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

  4. Evaluation of oxidant burden: oxidized LDL

    Time frame: Baseline

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

  5. Evaluation of oxidant burden: nitrotyrosine

    Time frame: Baseline

    Nitrotyrosine measured in the blood and endothelial cells.

  6. Evaluation of vascular endothelial cell inflammation: NFkB

    Time frame: Baseline

    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

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

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

    Time frame: Baseline

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

  9. Evaluation of vascular endothelial cell inflammation: CRP

    Time frame: Baseline

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

  10. Blood pressure

    Time frame: Baseline

  11. Plasma lipid concentrations: total cholesterol

    Time frame: Baseline

    Total cholesterol will be determined at baseline.

  12. Plasma lipid concentrations: triglycerides

    Time frame: Baseline

    Triglycerides will be determined at baseline.

  13. Insulin sensitivity

    Time frame: Baseline

  14. Whole body composition: Percent Lean Mass

    Time frame: Baseline

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

  15. Whole body composition: Percent Fat Mass

    Time frame: Baseline

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

  16. Regional body composition: Percent Lean Mass

    Time frame: Baseline

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

  17. Regional body composition: Percent Fat Mass

    Time frame: Baseline

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

  18. Body weight

    Time frame: Baseline

  19. Appetite ratings

    Time frame: Baseline

  20. Appetite-related peptides

    Time frame: Baseline

  21. D-Dimer

    Time frame: Baseline

  22. Alcohol use

    Time frame: Baseline

  23. Depression symptoms

    Time frame: Baseline

  24. Physical activity monitoring

    Time frame: 7 days

    Physical activity will me monitored for 7 days with an ActivPALmonitor

  25. Energy intake

    Time frame: 3 days

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2020
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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