Mayo clinic launches study on hormone therapy's impact on muscle in transgender individuals
NCT ID NCT06083766
First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This study from Mayo Clinic looks at how gender-affirming hormone therapy (GAHT) changes muscle metabolism and function in transgender and gender diverse people. Researchers will measure muscle energy use and overall physical health in 24 adults aged 18-40 who have been on GAHT for at least 10 months. The goal is to better understand the body's response to hormone therapy, not to test a new drug or treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gender-affirming hormone therapy
- What this could lead to
- If successful, this study could help doctors better understand how hormone therapy affects muscle health, potentially improving care for transgender and gender diverse people.
- What could go wrong
- This is a small, early-stage observational study with only 24 participants. It is designed to gather knowledge, not to test a new treatment, so direct health benefits are not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Transgender and Gender Diverse People Residents within a 100-mile radius of Mayo Clinic, Rochester, MN.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States