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

NCT06083766 | Recruiting

• 1 other identifier: 23-006826
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Transgender; Gender Diverse

Outcome Measures

Primary Outcomes (1)

• Aim 1

  To identify the impact of gender-affirming hormone therapy (GAHT) on skeletal muscle mitochondrial metabolism in transgender and gender diverse individuals.

  2 weeks

Secondary Outcomes (1)

• Aim 2

  2 weeks

Study Arms (2)

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

Interventions

hormone therapy BEHAVIORAL

Determine how gender affirming hormone therapy affects muscle physiology

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)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Transgender and Gender Diverse People Residents within a 100-mile radius of Mayo Clinic, Rochester, MN.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine, tissue

Central Study Contacts

Jennifer R Hewlett, M.D.

CONTACT

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

Rose A Decker

CONTACT

507-255-6770; bilderback.rose@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: January 4, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)