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

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT06116201

Collaborator

(none)

Enrollment

Location

Arms

18.9

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transgender Women	Other: Estradiol Other: Estradiol and Anti-Androgen Other: No intervention	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Heart rate [Baseline]
Heart rate will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
Blood pressure [Baseline]
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.
Body weight [Baseline]
Body weight and height will be measured with automated body composition machine (ioi 353, Jawon medical).
Height [Baseline]
Height will be measured with automated body composition machine (ioi 353, Jawon medical).
Resting metabolic rate [Baseline]
Energy expenditure will be measured by canopy study protocol with stationary gas analyzer (VMAX, Encore 29 system).
Vascular structure [Baseline]
Intima-Media Thickness will be measured with ultrasonography equipment on carotid artery (EPIQ 5G, Phillips).
Macro vascular function [Baseline]
Macro vascular function will be measured by brachial artery flow-mediated dilatation protocol on brachial artery with ultrasonography equipment (EPIQ 5G, Phillips).
Arterial stiffness [Baseline]
Arterial stiffness will be measured with brachial-ankle pulse wave velocity (VP-1000 plus, omrom Healthcare).
Micro vascular function [Baseline]
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).
Muscle mass [Baseline]
Muscle mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Fat mass [Baseline]
Fat mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Bone mineral content [Baseline]
Bone mineral content will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Bone mineral density [Baseline]
Bone mineral density will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
T-score of bone density [Baseline]
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.
Cardiorespiratory fitness [Baseline]
Maximal oxygen consumption will be measured by Bruce protocol for treadmill test with stationary gas analyzer (VMAX, Encore 29 system).
Muscle strength and muscle endurance [Baseline]
Muscle strength and muscle endurance will be measured by concentric/concentric protocol with isokinetic machine (Biodex Multi-Joint System-Pro, Biodex).
Flexibility [Baseline]
Sit and reach test will be measured by sit and reach protocol with sit and reach box (Grandsport).
Agility [Baseline]
Agility will be measured by T-test protocol with timing gate device (SpeedLight Timing System, Swiftperformance).
Balance [Baseline]
Balance will be measured by balance error scoring system (BESS) protocol with postural sway detected machine (Biosway, Biodex).
Coordination and reaction time [Baseline]
Coordination and reaction time will be measured by eye-hand coordination protocol with light reacted device (FITLIGHT Trainer).
Muscular power [Baseline]
Muscular power will be measured by vertical jump with force plate detected machine (Ballistic Measurement System & FT 700 Power Cage, Fitness Technology).
Speed [Baseline]
Speed will be measured by sprint test for 40 meters with timing gate device (SpeedLight Timing System, Swiftperformance).
Anaerobic fitness [Baseline]
Anaerobic fitness will be measured by Wingate test protocol with ergocycle (Monark 894e).

Secondary Outcome Measures

Quality of life level [Baseline]
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.
Stress level [Baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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).