Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

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

Sponsors

Lead Sponsor: St. Louis University

Source St. Louis University
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.

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 1. 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. 2. the mechanism that lead to growth or suppression of fat mass or lean mass 3. 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.

Overall Status Recruiting
Start Date October 6, 2020
Completion Date December 31, 2023
Primary Completion Date December 31, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Androgen receptor 6 months
Secondary Outcome
Measure Time Frame
Estrogen receptor and aromatase 6 months
inflammation 6 months
autophagy 6 months
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: testosterone cypionate

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

Arm Group Label: Transmen

Intervention Type: Drug

Intervention Name: Estradiol Valerate

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

Arm Group Label: transwomen

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Gender Based: Yes

Gender Description: 2 groups based on gender identity: transowmen and transmen

Minimum Age: 18 Years

Maximum Age: 50 Years

Overall Official
Last Name Role Affiliation
Sandeep Singh Dhindsa F.A.C.E, MD Principal Investigator St. Louis University
Overall Contact

Last Name: Sandeep Dhindsa, MD

Phone: 7165981544

Email: [email protected]

Location
Facility: Status: Contact: Saint Louis Univeristy Bobby Campbell
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: St. Louis University

Investigator Full Name: Sandeep Singh Dhindsa, M.D., F.A.C.E

Investigator Title: Professor of Medicine

Has Expanded Access No
Condition Browse
Arm Group

Label: Transmen

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

Label: transwomen

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

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov