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Recruiting NCT06083766

Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People

— Observational Effects of GAHT, on Skeletal Muscle in TGD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hormone therapy.
Who it may be relevant to
Registry conditions: Effects of GAHT, on Skeletal Muscle in TGD. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral hormone therapy
    Determine how gender affirming hormone therapy affects muscle physiology

Primary outcome measures

  • Aim 1 [Time frame: 2 weeks]
Secondary outcome measures (1)
  • Aim 2 [Time frame: 2 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06083766 · 23-006826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗