Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

Transgenderism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04551144
• Other study ID #: 31184
• Status: Terminated
• Start date: October 6, 2020
• Est. completion date: January 18, 2023

Study information

• Verified date: January 2024
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gender Dysphoria
• Gender Incongruence
• Transgenderism

Intervention

Drug:
• testosterone cypionate
intramuscular injection every 2 weeks. Dose will be titrated based on blood levels
• Estradiol Valerate
intramuscular injection every week. Dose will be titrated based on blood levels

Locations

Country	Name	City	State
United States	Saint Louis Univeristy	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Androgen receptor	change in Androgen receptor expression in subcutaneous adipose tissue in transmen	6 months
Secondary	Estrogen receptor and aromatase	Expression and protein content of estrogen receptor alpha and aromatase in muscle and fat of transmen and transwomen	6 months
Secondary	inflammation	expression of inflammatory mediators in fat tissue and circulating levels in serum	6 months
Secondary	autophagy	Assessment of autophagic flux in fat and muscle biopsies	6 months