Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

Sponsor

St. Louis University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04551144

Collaborator

(none)

Enrollment

Location

38.8

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to find out if hormone therapy in transgender subjects' changes hormone receptors in blood, muscle and fat; fat production; muscle production; and inflammation processes.

Condition or Disease	Intervention/Treatment	Phase
Gender Incongruence Transgenderism	Drug: testosterone cypionate Drug: Estradiol Valerate

Detailed Description

Throughout recorded history, some men and women have experienced emotional distress at being physically "trapped" in wrong gender. Gender incongruence refers to the state where one's internal sense of gender differs from the gender assigned at birth. Advances in psychology and in our understanding of human sexuality have permitted the recognition of gender incongruence (also called transgender) as a biological phenomenon. The acceptance by the society has led to an expansion of health care services available to these individuals for supportive treatment. Gender affirming hormone therapy, usually provided by endocrinologists, is pivotal for the transition of these individuals into their desired gender. This therapy typically consists of testosterone or estrogen (male and female sex hormones) to transition into transmen or transwomen, respectively. The hormone treatment results in a "second puberty", wherein biological men receiving estrogen gain fat around hips and thighs, lose muscle and develop breasts. Biological women receiving testosterone lose fat, gain muscle, stop having menses and develop a deeper voice. However, our knowledge of the mechanisms of these hormones at the tissue level in transgender population is lacking. In this study, we plan to evaluate

hormone receptors that carry out the action of sex hormones in fat tissue and mononuclear cells (a type of immune cell in blood) following gender affirming therapy.
the mechanism that lead to growth or suppression of fat mass or lean mass
effect on inflammation (a cardiovascular risk marker) The hormone treatment of gender incongruence is a relatively untested therapy. The treatment is based on extrapolations and assumptions from hormone treatment in hypogonadal (hormone deficient) in cis-gender (same gender, no incongruence) individuals. We expect that our mechanistic studies will initiate an understanding into the actions of transgender therapy at the cellular level.

Study Design

Study Type:

Observational

Actual Enrollment :

4 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Transgender Therapy on Hormone Receptors, Adipogenesis, Myogenesis and Inflammation

Actual Study Start Date :

Oct 6, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Transmen Subjects starting testosterone therapy as part of standard of care for gender incongruence	Drug: testosterone cypionate intramuscular injection every 2 weeks. Dose will be titrated based on blood levels
transwomen Subjects starting estradiol therapy as part of standard of care for gender incongruence	Drug: Estradiol Valerate intramuscular injection every week. Dose will be titrated based on blood levels

Arm

Intervention/Treatment

Transmen

Subjects starting testosterone therapy as part of standard of care for gender incongruence

Drug: testosterone cypionate

intramuscular injection every 2 weeks. Dose will be titrated based on blood levels

transwomen

Subjects starting estradiol therapy as part of standard of care for gender incongruence

Drug: Estradiol Valerate

intramuscular injection every week. Dose will be titrated based on blood levels

Outcome Measures

Primary Outcome Measures

Androgen receptor [6 months]
change in Androgen receptor expression in subcutaneous adipose tissue in transmen

Secondary Outcome Measures

Estrogen receptor and aromatase [6 months]
Expression and protein content of estrogen receptor alpha and aromatase in muscle and fat of transmen and transwomen
inflammation [6 months]
expression of inflammatory mediators in fat tissue and circulating levels in serum
autophagy [6 months]
Assessment of autophagic flux in fat and muscle biopsies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Diagnosed with gender incongruence by a mental health professional and willing to start gender affirming therapy

Exclusion Criteria:

Used hormone therapy in last 6 months,
Pregnancy,
Planning to have biological children in the next one year,
HIV Additional exclusion criteria for transmen: 1) hematocrit >50% for transmen, 2) transmen with allergy to cottonseed oil (component of intramuscular testosterone injection), 3) uncompensated heart failure, 4) renal failure Additional exclusion criteria for transwomen: 1) allergy to castor oil (component of intramuscular estradiol injection), 2) Known or suspected estrogen-dependent neoplasia, 3) Active deep vein thrombosis, pulmonary embolism or a history of these conditions, 4) Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction), 5) Liver enzymes (AST or ALT) >3 times the upper limit of normal, 6) Known or suspected pregnancy