Effects of GAHT, on Skeletal Muscle in TGDNCT06083766
Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People
An observational study of Effects of GAHT, on Skeletal Muscle in TGD, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of GAHT, on Skeletal Muscle in TGD
- What is being tested?
- hormone therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2024to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Transgender and Gender Diverse People Residents within a 100-mile radius of Mayo Clinic, Rochester, MN.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine Klaus contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jennifer R Hewlett, M.D., 507-266-9479, Hewlett.Jennifer@mayo.edu
Katherine Klaus, klaus.katherine@mayo.edu
About this study
The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology.
Read the detailed description
Study participation involves a screening visit and two study visits. The screen includes blood draws, and urine testing. The first visit requires a collection of breath, exercise testing, and body scans. Between visits participant are to eat three days of provided meals and wear an activity monitor. The second study visit will be 3-14 days after the first and includes blood draws, a meal test, and a muscle biopsy. If individuals are not on gender affirming hormone therapy at the time of participation, they may be able to participate again if you decide to pursue gender affirming hormone therapy later on.
- Being tested
- hormone therapy
- Keywords
- Transgender, Gender Diverse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hormone therapyBehavioural
Determine how gender affirming hormone therapy affects muscle physiology
| Study group | Role | What they receive |
|---|---|---|
| Transmasculine/transfeminine individuals and/or transgender men/women (whom are NOT receiving GAHT) | Not described Receives: Behavioral: hormone therapy | |
| Transmasculine/transfeminine individuals and/or transgender men/women (whom ARE receiving GAHT) | Not described Receives: Behavioral: hormone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1
To identify the impact of gender-affirming hormone therapy (GAHT) on skeletal muscle mitochondrial metabolism in transgender and gender diverse individuals.
Measured: 2 weeks
Secondary outcomes (1)
Aim 2
To determine changes in important parameters of physiologic and functional health following gender-affirming hormone therapy (GAHT) in and gender diverse people.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start4 Jan 2024
- Primary completionApr 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of GAHT, on Skeletal Muscle in TGDStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Sreekumaran Nair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083766
- Sponsor's protocol ID
- 23-006826
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People
- ClinicalTrials.gov ID
- NCT06083766
- Acronym / sponsor ID
- 23-006826
- Keywords
- Transgender, Gender Diverse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology.
Detailed description
Study participation involves a screening visit and two study visits. The screen includes blood draws, and urine testing. The first visit requires a collection of breath, exercise testing, and body scans. Between visits participant are to eat three days of provided meals and wear an activity monitor. The second study visit will be 3-14 days after the first and includes blood draws, a meal test, and a muscle biopsy. If individuals are not on gender affirming hormone therapy at the time of participation, they may be able to participate again if you decide to pursue gender affirming hormone therapy later on.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmasculine/transfeminine individuals and/or transgender men/women (whom are NOT receiving GAHT) | – | Behavioral: hormone therapy |
| Transmasculine/transfeminine individuals and/or transgender men/women (whom ARE receiving GAHT) | – | Behavioral: hormone therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Transgender and Gender Diverse People Residents within a 100-mile radius of Mayo Clinic, Rochester, MN.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hormone therapyDetermine how gender affirming hormone therapy affects muscle physiology | Behavioural | Transmasculine/transfeminine individuals and/or transgender men/women (whom ARE receiving GAHT), Transmasculine/transfeminine individuals and/or transgender men/women (whom are NOT receiving GAHT) |
Primary outcome
Aim 1
Time frame: 2 weeks
To identify the impact of gender-affirming hormone therapy (GAHT) on skeletal muscle mitochondrial metabolism in transgender and gender diverse individuals.
1 secondary outcome
Aim 2
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Klaus contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of GAHT, on Skeletal Muscle in TGD, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer R Hewlett, M.D. (507-266-9479, Hewlett.Jennifer@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.