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

Not Applicable

Recruiting

• Conditions: Hormonal Gender-Affirming Therapy
• Interventions: Diagnostic Test: Spirometry; Diagnostic Test: Plethysmography

• Registration Number: NCT05587751
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-20
• Study Start: 2023-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Function in Transgender and Gender Diverse Patients	Plethysmography	Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function
Pulmonary Function in Transgender and Gender Diverse Patients	Spirometry	Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time of "gender adjustment" of PFT's normative values	Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up	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.

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States