Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

NCT ID: NCT04551144

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2023-01-18

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.

Conditions

Gender Incongruence; Transgenderism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Transmen

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

testosterone cypionate

Intervention Type: DRUG

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

Estradiol Valerate

Intervention Type: DRUG

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

Interventions

testosterone cypionate

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

Intervention Type: DRUG

Estradiol Valerate

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

Intervention Type: DRUG

Eligibility 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Sandeep Singh Dhindsa, M.D., F.A.C.E

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandeep Dhindsa, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

Saint Louis Univeristy

St Louis, Missouri, United States

Countries

United States

Other Identifiers

31184

Identifier Type: -

Identifier Source: org_study_id