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The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirometry | Diagnostic Test | Pulmonary function test to measure lung function |
|
| 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 |
| 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 |
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Inclusion Criteria:
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):
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla Quinn, MS | Contact | 800-752-1606 | quinn.kayla2@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gustavo Cortes Puentes, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D013147 | Spirometry |
| D010991 | Plethysmography |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Plethysmography | Diagnostic Test | Pulmonary function test to measure lung volume |
|
| D003935 | Diagnostic Techniques, Cardiovascular |