Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People (NCT06083766) | Clinical Trial Compass
RecruitingNot Applicable
Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People
United States24 participantsStarted 2024-01-04
Plain-language summary
The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.