Clinical trial NCT02185274: Observational Study on Metabolism and Psychopathology in Transsexual Patients
Official title: Observational Study on the Short- and Long-term Effects of Cross-sex-hormone Treatment on Metabolism and Psychopathology in Transsexuals Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transsexualism
Keywords: Transsexualism
Cross-sex hormone treatment
Sex hormones
Mood
Stress
Cortisol
Cardiovascular
Metabolome
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
Collaborators: name: University of Erlangen-Nürnberg Medical School
name: Institute for Sex Research and Forensic Psychiatry, Hamburg, Germany
name: Hormon-und Stoffwechselzentrum München, Munich, Germany
First posted: 2014-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the outpatient clinics of the corresponding centres. Every patient is eligible who has not yet received any cross-sex hormone treatment. Patients will be invited to participate at the regular visit after which it is planned to start hormone treatment. Further visits will follow the regular check-up visits in the corresponding centers.

Brief summary: Gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. Most patients therefore undergo so called cross-sex hormone treatment. Treatment protocols follow international consensus statements but vary considerably between different centres and countries since no prospective and controlled trials are available on this subject and recommendations are mainly based on retrospective data analysis and experience of the individual centres. Applying high doses of testosterone to biological females and vice versa high doses of estradiol to biological males definitely impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. Especially in male-to-female-transsexuals there seems to be an increased risk for the development of mood disorders and cardiometabolic comorbidities. In this multi-center observational study we want to investigate, if there is any difference with regard to these outcomes, according to the varying standards of cross-sex hormone treatment between the different centers. Different outcome measures described below will be assessed each time during routine visits at the different centers.


Eligibility criteria: Inclusion criteria

* Patients with the diagnosis gender identity disorder (ICD-10: F64.0), who have given written informed consent following adequate oral and written information.

General Exclusion criteria

* Patients below the age of 18
* Legally incompetent patients
* Prior intake of cross-sex hormones
* Missing written informed consent
* Intersexuality

Primary outcomes:
measure: Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment
timeFrame: Up to 5 years
measure: Differences in the effects of the different treatment types on cardiometabolic parameters
timeFrame: Up to 5 years
Secondary outcomes:
measure: Effects of cross-sex hormone treatment on cortisol secretion by hair cortisol measurements
timeFrame: Up to 5 years
measure: Effects of cross-sex hormone treatment on stress-response by means of Dex/CRH-testing
timeFrame: Up to 5 years
measure: Genetic predictors for treatment response
timeFrame: Up to 5 years
measure: Effects of cross-sex hormone treatment on the metabolome
timeFrame: Up to 5 years
measure: Effects of cross-sex hormone treatment on peripheral neurotrophins
timeFrame: Up to 5 years
measure: Association of hair cortisol and cortisol response during dex/crh-testing with psychopathology-scores assessed by clinical interview and questionnaires
timeFrame: Up to 5 years
measure: Predictive value of hair cortisol and cortisol response in dex/crh-testing treatment for depression and anxiety
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Gynaecological department of the University hospital of Erlangen
city: Hamburg
country: Germany
facility: Institute for Sex Research and Forensic Psychiatry
city: Munich
country: Germany
facility: Hormon- und Stoffwechselzentrum München
Study officials:
affiliation: Max Planck Insitute of Psychiatry, Department of Neuroendocrinology
name: Matthias K Auer, MD
role: PRINCIPAL_INVESTIGATOR
References: