Effects of hormone therapy on muscle physiology in transgender and gender diverse individuals
Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People
This study is testing how hormone therapy affects muscle health in transgender and gender diverse individuals who have been on treatment for at least 10 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06083766 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate how gender-affirming hormone therapy (GAHT) influences muscle physiology in transgender and gender diverse (TGD) individuals. Participants will undergo a screening visit followed by two study visits, which include blood draws, urine testing, exercise testing, and muscle biopsies. During the study, participants will consume provided meals and wear activity monitors to track their physical activity. The study seeks to enroll individuals who have been on GAHT for over 10 months with minimal interruptions.
Who should consider this trial
Good fit: Ideal candidates are transgender and gender diverse individuals aged 18-40 who have been on hormone therapy for more than 10 months.
Not a fit: Patients who are pregnant or have undergone gender-affirming gonadal surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the physiological effects of hormone therapy, potentially improving treatment protocols for TGD individuals.
How similar studies have performed: While there is ongoing research in this area, this specific approach to studying muscle physiology in TGD individuals undergoing GAHT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-40yrs * BMI 18.5-38 kg/m2 * Fasting glucose \< 100 mg/dL * No gender affirming gonadal surgery We seek to enroll 6 patients in each group who have been on GAHT for more than 10 months with minimal interruptions in treatment. Exclusion Criteria: * Pregnancy * Use of hormonal forms of birth control within the previous 3 months * Use of glucocorticoids, estradiol, testosterone, progestin, antiandrogens, or antiestrogens besides those received as part of a supervised hormone therapy. * Gender-affirming gonadal surgery * Prior use of gonadotropin releasing hormone (GnRH) analogues during puberty * Coronary artery disease or heart failure. * A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: * Inpatient psychiatric treatment in the past 6 months * Presence of a known adrenal disorder * Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function * Abnormal renal function test results (calculated GFR \<45 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty * Active gastroparesis * If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study * Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise * Abuse of alcohol or recreational drugs * Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis). * Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg) at the time of screening. * A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol (exercise testing or muscle biopsy). * Medications that may impact study end points such as mitochondrial biology e.g. beta blockers * Anti-hyperglycemic drugs including metformin * Any other medication that the investigator believes is a contraindication to the subject's participation.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer R Hewlett, M.D.
- Email: Hewlett.Jennifer@mayo.edu
- Phone: 507-266-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.