Recruiting

Hormone Therapy

Sponsor:

Mayo Clinic

Code:

NCT06083766

Conditions

Effects of GAHT, on Skeletal Muscle in TGD

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

hormone therapy

Study Details

Brief summary:

The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology.

Conditions

Effects of GAHT, on Skeletal Muscle in TGD

Study ID

NCT06083766

Start date

Jan 4, 2024

Status verified date

Jul, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

Transmasculine/transfeminine individuals and/or transgender men/women (whom are NOT receiving GAHT)

Transmasculine/transfeminine individuals and/or transgender men/women (whom ARE receiving GAHT)

Interventions

hormone therapy

Determine how gender affirming hormone therapy affects muscle physiology

Primary outcome measure

  • Aim 1 [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Jennifer R Hewlett, M.D.

507-266-9479Hewlett.Jennifer@mayo.edu

Katherine Klaus

klaus.katherine@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jennifer R Hewlett, M.D.

507-266-9479Hewlett.Jennifer@mayo.edu

Katherine Klaus

klaus.katherine@mayo.edu

Principal Investigator:

K S Nair, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Keywords

  • Transgender
  • Gender Diverse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.