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

Официальное название

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

Обзор

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

Вмешательства

• Диагностический тест Spirometry
  Pulmonary function test to measure lung function
• Диагностический тест Plethysmography
  Pulmonary function test to measure lung volume

Первичные конечные точки

• Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume) [Срок оценки: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up]
• Change in forced expiratory volume [Срок оценки: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up]
• Change in forced vital capacity [Срок оценки: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up]
• Change in peak expiratory flow [Срок оценки: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up]
• Change in maximal mid-expiratory flow rate [Срок оценки: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up]

Вторичные конечные точки (1)

• Time of "gender adjustment" of PFT's normative values [Срок оценки: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Mayo Clinic Rochester — Rochester

Идентификаторы

NCT: NCT05587751 · 22-007173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗