Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women

NCT06116201 | Completed

• 1 other identifier: SPSC-7
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Transgender women who transitioned from male to female by hormone therapy demonstrate similar physical fitness and vascular function to males or females.

Conditions

Transgender Women

Keywords

Transgender women; Physical fitness; Vascular function; Hormone therapy

Outcome Measures

Primary Outcomes (23)

• Heart rate

  Heart rate will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).

  Baseline

• Blood pressure

  Systolic blood pressure and diastolic blood pressure will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap). Mean arterial blood pressure was calculated from systolic blood pressure and diastolic blood pressure via mean arterial pressure formula.

  Baseline

• Body weight

  Body weight and height will be measured with automated body composition machine (ioi 353, Jawon medical).

  Baseline

• Height

  Height will be measured with automated body composition machine (ioi 353, Jawon medical).

  Baseline

• Resting metabolic rate

  Energy expenditure will be measured by canopy study protocol with stationary gas analyzer (VMAX, Encore 29 system).

  Baseline

• Vascular structure

  Intima-Media Thickness will be measured with ultrasonography equipment on carotid artery (EPIQ 5G, Phillips).

  Baseline

• Macro vascular function

  Macro vascular function will be measured by brachial artery flow-mediated dilatation protocol on brachial artery with ultrasonography equipment (EPIQ 5G, Phillips).

  Baseline

• Arterial stiffness

  Arterial stiffness will be measured with brachial-ankle pulse wave velocity (VP-1000 plus, omrom Healthcare).

  Baseline

• Micro vascular function

  Micro vascular function will be measured by post-occlusive hyperemia protocol of fingertip cutaneous blood flow with laser doppler flowmetry device (PeriFlux system 5000, Perimed).

  Baseline

• Muscle mass

  Muscle mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

  Baseline

• Fat mass

  Fat mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

  Baseline

• Bone mineral content

  Bone mineral content will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

  Baseline

• Bone mineral density

  Bone mineral density will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

  Baseline

• T-score of bone density

  T-score will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare). T-score was separated into 3 categories, 1 or higher of T-score that is the healthy bone, -1 to -2.5 of T-score that is osteopenia, and -2.5 or lower that is osteoporosis.

  Baseline

• Cardiorespiratory fitness

  Maximal oxygen consumption will be measured by Bruce protocol for treadmill test with stationary gas analyzer (VMAX, Encore 29 system).

  Baseline

• Muscle strength and muscle endurance

  Muscle strength and muscle endurance will be measured by concentric/concentric protocol with isokinetic machine (Biodex Multi-Joint System-Pro, Biodex).

  Baseline

• Flexibility

  Sit and reach test will be measured by sit and reach protocol with sit and reach box (Grandsport).

  Baseline

• Agility

  Agility will be measured by T-test protocol with timing gate device (SpeedLight Timing System, Swiftperformance).

  Baseline

• Balance

  Balance will be measured by balance error scoring system (BESS) protocol with postural sway detected machine (Biosway, Biodex).

  Baseline

• Coordination and reaction time

  Coordination and reaction time will be measured by eye-hand coordination protocol with light reacted device (FITLIGHT Trainer).

  Baseline

• Muscular power

  Muscular power will be measured by vertical jump with force plate detected machine (Ballistic Measurement System \& FT 700 Power Cage, Fitness Technology).

  Baseline

• Speed

  Speed will be measured by sprint test for 40 meters with timing gate device (SpeedLight Timing System, Swiftperformance).

  Baseline

• Anaerobic fitness

  Anaerobic fitness will be measured by Wingate test protocol with ergocycle (Monark 894e).

  Baseline

Secondary Outcomes (2)

• Quality of life level

  Baseline

• Stress level

  Baseline

Study Arms (4)

Transgender women with orchiectomy

EXPERIMENTAL

Transgender women who took medication for sex transition form male to female via estradiol hormone therapy and orchiectomy surgery. They were recruited for measurement of all variables in the study to compare with another group.

Other: Estradiol

Transgender women without orchiectomy

EXPERIMENTAL

Transgender women who took medication for sex transition form male to female via estradiol hormone and anti-androgen hormone therapy. They were recruited for measurement of all variables in the study to compare with another group.

Other: Estradiol and Anti-Androgen

Cisgender men

SHAM COMPARATOR

Cisgender men who lived in normal life were not used medication process for sex transition. They were recruited for measurement of all variables in the study to compare with another group.

Other: No intervention

Cisgender women

SHAM COMPARATOR

Cisgender women who lived in normal life were not used medication process for sex transition. They were recruited for measurement of all variables in the study to compare with another group.

Other: No intervention

Interventions

Estradiol OTHER

Estradiol

Transgender women with orchiectomy

Estradiol and Anti-Androgen OTHER

Estradiol and Anti-Androgen

Transgender women without orchiectomy

No intervention OTHER

No intervention

Cisgender men; Cisgender women

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Cisgender men, Cisgender women, Transgender women with orchiectomy, Transgender women without orchiectomy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cisgender men group (Body mass index between 18.5-24.9 and NO NCDs).
• Cisgender women group (Body mass index between 18.5-24.9, No pregnant, NO NCDs).
• Transgender women with orchiectomy (Body mass index between 18.5-24.9, taking estradiol, testosterone level below 10 nmol/L, NO NCDs).
• Transgender women without orchiectomy (Body mass index between 18.5-24.9, taking estradiol and anti-androgen, testosterone level below 10 nmol/L, NO NCDs).

You may not qualify if:

• Participants had an injury during testing.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (1)

• Saitong A, Naeowong W, Suksom D, Tanaka H. Physical Fitness and Exercise Performance of Transgender Women. Med Sci Sports Exerc. 2025 Jan 1;57(1):134-143. doi: 10.1249/MSS.0000000000003536. Epub 2024 Aug 12.

  PMID: 39140786 DERIVED

MeSH Terms

Interventions

Estradiol; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Daroonwan Suksom, Ph.D.

  Chulalongkorn University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Sports Science

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: November 3, 2023
• Study Start: August 15, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)