Observational Study on Metabolism and Psychopathology in Transsexual Patients

NCT02185274 | Completed

• 1 other identifier: MPIP-ENDO1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Transsexualism

Keywords

Transsexualism; Cross-sex hormone treatment; Sex hormones; Mood; Stress; Cortisol; Cardiovascular; Metabolome

Outcome Measures

Primary Outcomes (2)

• Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment

  Incidence of depressive and anxious symptoms by means of clinical interview and questionnaires in the the study period defined by different cut-off points in the point scales of the corresponding questionnaire (Beck Depression Inventory II = BDII and Symptomcheckliste bei psychischen Störungen = SCL90 for depression and State and Trait Anxiety Inventory = STAI-X1, X2 for anxiety). A comparison will then be done between the different treatment modes.

  Up to 5 years

• Differences in the effects of the different treatment types on cardiometabolic parameters

  Differences in the effects of the different treatment types (differing in dose, application route and type of antiandrogen used) on cardiometabolic risk-parameters such as BMI, body-composition, fasting Insulin, fasting glucose, triglycerides, cholesterol, intima media thickness.

  Up to 5 years

Secondary Outcomes (7)

• Effects of cross-sex hormone treatment on cortisol secretion by hair cortisol measurements

  Up to 5 years

• Effects of cross-sex hormone treatment on stress-response by means of Dex/CRH-testing

  Up to 5 years

• Genetic predictors for treatment response

  Up to 5 years

• Effects of cross-sex hormone treatment on the metabolome

  Up to 5 years

• Effects of cross-sex hormone treatment on peripheral neurotrophins

  Up to 5 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead
• University of Erlangen-Nürnberg Medical School: collaborator
• Institute for Sex Research and Forensic Psychiatry, Hamburg, Germany: collaborator
• Hormon-und Stoffwechselzentrum München, Munich, Germany: collaborator

Study Sites (3)

Gynaecological department of the University hospital of Erlangen

Erlangen, 91054, Germany

Location

Institute for Sex Research and Forensic Psychiatry

Hamburg, 20246, Germany

Location

Hormon- und Stoffwechselzentrum München

Munich, 80333, Germany

Location

Related Publications (1)

• Liwinski T, Auer MK, Schroder J, Pieknik I, Casar C, Schwinge D, Henze L, Stalla GK, Lang UE, von Klitzing A, Briken P, Hildebrandt T, Desbuleux JC, Biedermann SV, Holterhus PM, Bang C, Schramm C, Fuss J. Gender-affirming hormonal therapy induces a gender-concordant fecal metagenome transition in transgender individuals. BMC Med. 2024 Sep 2;22(1):346. doi: 10.1186/s12916-024-03548-z.

  PMID: 39218875 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* 2 x 10ml serum * 10ml urine * Hair sample * 7,5ml EDTA-Blood for DNA and plasma * 2,5ml blood for mRNA-Analysis * 8,5ml stabilized serum * Stool sample (2-5ml)

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• Matthias K Auer, MD

  Max Planck Insitute of Psychiatry, Department of Neuroendocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: July 9, 2014
• Study Start: October 1, 2013
• Primary Completion: October 31, 2019
• Study Completion: November 30, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

DE (3)