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

January 17, 2024 updated by: K. Sreekumaran Nair, Mayo Clinic
The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transmasculine/transfeminine individuals and/or transgender men/women (whom are NOT receiving GAHT)
Behavioral: hormone therapy
Determine how gender affirming hormone therapy affects muscle physiology
Transmasculine/transfeminine individuals and/or transgender men/women (whom ARE receiving GAHT)
Behavioral: hormone therapy
Determine how gender affirming hormone therapy affects muscle physiology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 2
Time Frame: 2 weeks
To determine changes in important parameters of physiologic and functional health following gender-affirming hormone therapy (GAHT) in and gender diverse people.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-006826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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