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

Mayo Clinic2 个研究点分布在 1 个国家目标入组 44 人开始时间: 2023年2月1日最近更新: 2026年5月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Mayo Clinic
入组人数: 44
试验地点: 2
主要终点: Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 14 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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).

排除标准

•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.

研究组 & 干预措施

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

干预措施: Spirometry (Diagnostic Test)

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

干预措施: Plethysmography (Diagnostic Test)

结局指标

主要结局

Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)