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

Transgender Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116201
• Other study ID #: SPSC-7
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: November 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transgender Women

Intervention

Other:
• Estradiol
Estradiol
• Estradiol and Anti-Androgen
Estradiol and Anti-Androgen
• No intervention
No intervention

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).	Baseline
Primary	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
Primary	Body weight	Body weight and height will be measured with automated body composition machine (ioi 353, Jawon medical).	Baseline
Primary	Height	Height will be measured with automated body composition machine (ioi 353, Jawon medical).	Baseline
Primary	Resting metabolic rate	Energy expenditure will be measured by canopy study protocol with stationary gas analyzer (VMAX, Encore 29 system).	Baseline
Primary	Vascular structure	Intima-Media Thickness will be measured with ultrasonography equipment on carotid artery (EPIQ 5G, Phillips).	Baseline
Primary	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
Primary	Arterial stiffness	Arterial stiffness will be measured with brachial-ankle pulse wave velocity (VP-1000 plus, omrom Healthcare).	Baseline
Primary	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
Primary	Muscle mass	Muscle mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).	Baseline
Primary	Fat mass	Fat mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).	Baseline
Primary	Bone mineral content	Bone mineral content will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).	Baseline
Primary	Bone mineral density	Bone mineral density will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).	Baseline
Primary	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
Primary	Cardiorespiratory fitness	Maximal oxygen consumption will be measured by Bruce protocol for treadmill test with stationary gas analyzer (VMAX, Encore 29 system).	Baseline
Primary	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
Primary	Flexibility	Sit and reach test will be measured by sit and reach protocol with sit and reach box (Grandsport).	Baseline
Primary	Agility	Agility will be measured by T-test protocol with timing gate device (SpeedLight Timing System, Swiftperformance).	Baseline
Primary	Balance	Balance will be measured by balance error scoring system (BESS) protocol with postural sway detected machine (Biosway, Biodex).	Baseline
Primary	Coordination and reaction time	Coordination and reaction time will be measured by eye-hand coordination protocol with light reacted device (FITLIGHT Trainer).	Baseline
Primary	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
Primary	Speed	Speed will be measured by sprint test for 40 meters with timing gate device (SpeedLight Timing System, Swiftperformance).	Baseline
Primary	Anaerobic fitness	Anaerobic fitness will be measured by Wingate test protocol with ergocycle (Monark 894e).	Baseline
Secondary	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
Secondary	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