Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.

Official Title
-----------------
Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients

Conditions
-----------------
Hormonal Gender-Affirming Therapy

Intervention / Treatment
-----------------
* Diagnostic Test: Spirometry
* Diagnostic Test: Plethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects speaking any language will be offered participation. Subjects capable of providing informed consent to the study. For those subjects younger than 18 years old who agree to participate in the study, informed consent will be obtained from patient's parents/guardian. Subjects capable of performing pulmonary function test (PFT) maneuvers, as per pulmonary function test laboratory protocol. Patients will be enrolled through the Mayo Clinic Rochester Transgender and Intersex Specialty Care Clinic (TISCC), once patient has decided to undergo hormonal gender-affirming therapies (pubertal blockers, and masculinizing or feminizing hormone therapies). Exclusion Criteria: Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians. The presence of contraindications for pulmonary function testing including (these will be reviewed at the time of recruitment and prior to each spirometry associated with the study): Recent surgical procedures (<3 months) that could be affected by lung function testing, including the following categories: Abdominal surgery, Eye surgery, Thoracic surgery, Ear surgery, Brain surgery, Vascular surgery. The presence of previously known respiratory disorders including pulmonary embolism (<6 months), pleural effusion, pneumothorax, hemoptysis. Recent myocardial infarction (<1 month), new cardiac arrythmia (<3 months), recent cardiac pacemaker implantation (<3 months). Heart failure symptoms, significant shortness of breath, tachycardia, or angina The presence of chronic pulmonary diseases that maybe associated with changes in pulmonary function overtime such as asthma, chronic obstructive pulmonary disease, or interstitial lung diseases.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary Function in Transgender and Gender Diverse Patients<br>Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function | Diagnostic Test: Spirometry<br>* Pulmonary function test to measure lung function<br>Diagnostic Test: Plethysmography<br>* Pulmonary function test to measure lung volume<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume) | The longitudinal changes in lung volumes after both masculinizing and feminizing hormone therapy in transgender and gender diverse (TGD) patients. | Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up | 
| Change in forced expiratory volume | Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath | Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up | 
| Change in forced vital capacity | Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L) | Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up | 
| Change in peak expiratory flow | Measured by a peak flow meter is the maximum forced expiratory flow, reported in liter per minute (L/min) | Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up | 
| Change in maximal mid-expiratory flow rate | Measured by spirometry to determine the rate of airflow where half of the forced vital capacity is exhaled | Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of gender adjustment of PFT's normative values | The time of gender adjustment of PFT's normative values (PFTs results correlate most closely with patient's gender than with their sex-assigned at birth) in response to gender-affirming hormone therapy in transgender and gender diverse (TGD) patients. | Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up |