Clinical trial NCT05587751: Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients
Official title: Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hormonal Gender-Affirming Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 44
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)
timeFrame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
measure: Change in forced expiratory volume
timeFrame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
measure: Change in forced vital capacity
timeFrame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
measure: Change in peak expiratory flow
timeFrame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
measure: Change in maximal mid-expiratory flow rate
timeFrame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Secondary outcomes:
measure: Time of "gender adjustment" of PFT's normative values
timeFrame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gustavo Cortes Puentes, MD
role: PRINCIPAL_INVESTIGATOR
References: