None listed
Conditions
Brief summary
Gender affirming hormone therapy is used by many transgender (trans) individuals and results in considerable changes in sex hormone levels (testosterone and estrogen). These hormonal changes affect skeletal muscle mass, but the underlying effects on physiological measures, such as aerobic fitness and muscle strength, as well as molecular markers such as epigenetics are unclear. Given the use of gender affirming hormone therapy by trans individuals is rising, it is critical that we further examine the short and long-term impacts of these therapies, with potential for research in this area to improve outcomes and personalise care for trans people and promote the fair inclusion of trans communities into sports commonly separated by gender. The aim of this project is to further understand the effects of gender affirming hormone therapy on physiological and molecular measures of skeletal muscle health and function. This study will include transgender participants commencing gender affirming hormone treatment, as well as of cisgender participants not undergoing any treatment, with all participants followed up over 12 months. The study involves participants undertaking aerobic and strength fitness tests and body composition scans and providing de-identified blood and muscle samples for analyses. Multiple outcomes will be assessed over 12 months, including changes in fitness tests, body composition, and epigenetic and blood markers such as DNA methylation and blood glucose. Outcomes will be compared before and after 6 and 12 months of hormone therapy in transgender individuals, and compared to outcomes in cisgender individuals, allowing us to assess the effects of gender affirming hormone treatments in depth.
Interventions
This is a prospective matched observational study in adults undergoing gender affirming hormone therapy, and age-matched controls. Participants undergoing gender affirming hormone therapy would have received these therapies regardless of their involvement in the study.
Assessments will take place at three timepoints for adults undergoing gender affirming therapy; prior to beginning gender affirming hormone treatment (baseline) and then at 6 and 12 months into treatment. Age-matched controls wil
This is a prospective matched observational study in adults undergoing gender affirming hormone therapy, and age-matched controls. Participants undergoing gender affirming hormone therapy would have received these therapies regardless of their involvement in the study. Assessments will take place at three timepoints for adults undergoing gender affirming therapy; prior to beginning gender affirming hormone treatment (baseline) and then at 6 and 12 months into treatment. Age-matched controls will be assessed at baseline and followed up after 12 months. Each timepoint will be divided into three examination days; day one: aerobic fitness tests (1.5-2 hour face-to-face session), day 2: muscle strength assessments (1.5-2 hour face-to-face session), and day three: body composition (DEXA) scans (only conducted at 0 and 12 months) and muscle and blood sampling (1-1.5 hour face-to-face session). Aerobic fitness tests and muscle strength assessments will be conducted by study researchers at Victoria University, with DEXA scans performed by a qualified technician and muscle/blood sampling performed by a medical doctor.
Sponsors
Victoria University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For participants commencing gender affirming hormone therapy: • Adults aged 18 years and over. • Willingness to consent and comply with study requirements • Diagnosed with gender dysphoria who are about to commence gender affirming hormone therapy For matched cisgender participants: • Adults aged 18 years and over. • Willingness to consent and comply with study requirements • Age-matched to participating individual about to commence gender affirming hormone therapy
Exclusion criteria
• Prior use of gender affirming hormone therapy. • Prior hypogonadism including previous oophorectomy or orchidectomy. • Past medical history of cardiovascular conditions, dizziness or fainting during exertion, significant chronic or recurrent respiratory condition, significant neuromuscular, major musculoskeletal problems interfering with ability to cycle, uncontrolled endocrine and metabolic disorders or diabetes requiring insulin and other therapies, infectious blood borne disease, disorders or use of medications that will affect blood clotting and allergies to anaesthetic. • Active cigarette use. • Language difficulties.
Outcome results
None listed