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

NCT05587751 | Recruiting FDA Device

• 1 other identifier: 22-007173
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.

Conditions

Hormonal Gender-Affirming Therapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Time of "gender adjustment" of PFT's normative values

  Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up

Study Arms (1)

Pulmonary Function in Transgender and Gender Diverse Patients

EXPERIMENTAL

Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function

Diagnostic Test: Spirometry; Diagnostic Test: Plethysmography

Interventions

Spirometry DIAGNOSTIC_TEST

Pulmonary function test to measure lung function

Pulmonary Function in Transgender and Gender Diverse Patients

Plethysmography DIAGNOSTIC_TEST

Pulmonary function test to measure lung volume

Pulmonary Function in Transgender and Gender Diverse Patients

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Spirometry; Plethysmography

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Gustavo Cortes Puentes, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla Quinn, MS

CONTACT

800-752-1606; quinn.kayla2@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 20, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)