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

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

Study Overview

• Status: Completed
• Conditions: Transgender Women
• Intervention / Treatment: Other: No intervention; Other: Estradiol; Other: Estradiol and Anti-Androgen

Detailed Description

This cross-sectional study was to compare physical fitness and vascular function between cisgender men, cisgender women, and transgender women.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Faculty of Sports Science, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Cisgender men group (Body mass index between 18.5-24.9 and NO NCDs).
2. Cisgender women group (Body mass index between 18.5-24.9, No pregnant, NO NCDs).
3. Transgender women with orchiectomy (Body mass index between 18.5-24.9, taking estradiol, testosterone level below 10 nmol/L, NO NCDs).
4. 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).

Exclusion Criteria:

• Participants had an injury during testing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transgender women with orchiectomy; 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; Estradiol
Experimental: Transgender women without orchiectomy; 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; Estradiol and Anti-Androgen
Sham Comparator: Cisgender men; 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; No intervention
Sham Comparator: Cisgender women; 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; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life level	Quality of life will level will be measured by World Health Organization Quality of Life Brief - Thai questionnaire. The scores of questionnaire were 130 points for maximum value and 26 points for minimum value. 3 levels in quality of life were less than 61 points for below normal range, 61-95 points for normal range, and more than 95 points for above normal range.	Baseline
Stress level	Stress level will be measured by Suanprung Stress Test-20 questionnaire. The scores of questionnaire were 100 points for maximum value and 20 points for minimum value. 4 levels in stress less than 24 points for low stress range, 24-41 points for normal stress range, 42-61 points for high stress range, and more than 61 points for severe stress range.	Baseline

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Study Director: Daroonwan Suksom, Ph.D., Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Transgender women; Physical fitness; Vascular function; Hormone therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Androgens; Androgen Antagonists
• Other Study ID Numbers: SPSC-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No