RECRUITING

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

Conditions

Effects of GAHT, on Skeletal Muscle in TGD Transgender Gender Diverse

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-01-04

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06083766

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.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* age 18-40yrs * BMI 18.5-38 kg/m2 * Fasting glucose \< 100 mg/dL * No gender affirming gonadal surgery	* 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.

Inclusion Criteria

Exclusion Criteria

* age 18-40yrs
* BMI 18.5-38 kg/m2
* Fasting glucose \< 100 mg/dL
* No gender affirming gonadal surgery

* 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.

Contacts and Locations

Study Contact

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 Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-01-04

Study Completion Date2026-07

Study Record Updates

Study Start Date2024-01-04

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Transgender
Gender Diverse

Additional Relevant MeSH Terms

Effects of GAHT, on Skeletal Muscle in TGD