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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hormonal Gender-Affirming Therapy
• Intervention / Treatment: Diagnostic test: Spirometry; Diagnostic test: Plethysmography

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kayla MacDonald, MS; Phone Number: 800-752-1606; Email: macdonald.kayla@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
      • Contact: Kayla L Macdonald; Phone Number: 507-538-0595; Email: macdonald.kayla@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Gustavo Cortes Puentes, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-007173

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: Yes