- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518009
GEnder Dysphoria Treatment in Sweden (GETS)
Phenotype Modulations Following Treatment With Contrary Sex Hormones
Gender dysphoria (DSM-5) or transsexualism (ICD10) is a condition in which a person's feeling of gender identity is not congruent with the physical body. The hormonal treatment includes inhibition of one's own sex hormone production followed by treatment with testosterone or estrogen levels that are normal for the opposite sex. Seen as experimental model, this is a process that provides an opportunity to study the sex hormone dependent influences that explain differences in morbidity in men and women respectively. The differences that are especially significant but not well known is 1) metabolic changes in the regulation of glucose homeostasis and lipid metabolism 2) regulation of vascular function and structural effects on the heart and arteries 3) regulation of skeletal muscle mass and fat tissue 4) morphological and functional effects on discrete areas of the brain.
Therefore, the investigators will follow these patients for a year to study how the heart, blood vessels, brain, and risk factors for cardiovascular disease affected by altered sex hormone patterns and studying what happens in the muscles and fat in both the short and long term with respect to particular gene expression and epigenetic changes and link it to metabolic changes and body composition.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
At the Centre for andrology and sexual medicine at Karolinska University Hospital about 30 genetic males (MtF) and 25 genetic females (FtM) every year start hormone replacement therapy. This hormonal treatment includes inhibition of one's own sex hormone production (down regulation of the gonadal axis) followed by treatment with testosterone or estrogen levels that are normal for the opposite sex. Seen as experimental model, this is a process that provides an opportunity to study the sex hormone dependent influences that explain differences in morbidity in men and women respectively. Furthermore, the constitutional differences distinguish them from those that are dynamically addressable through change in the hormonal milieu. The differences that are especially significant but not well known is 1) metabolic changes in the regulation of glucose homeostasis and lipid metabolism 2) regulation of vascular function and structural effects on the heart and arteries 3) regulation of skeletal muscle mass and fat tissue 4) morphological and functional effects on discrete areas of the brain.
It is well known that testosterone has a dose-response effect on body composition in men while conditions are less well known in women. Thus, it is not known how the adult woman's body responds to male levels of testosterone, and if the dose response relation is similar or different than that of men. The clinical impression is that women have less effect of androgen on muscle mass than men. Furthermore, it is not known whether the qualitative properties are comparable, i.e. muscle force/unit area. The basic hypothesis is that there are no constitutional sex differences in androgen response. If there are differences, we are looking to identify differences in gene expression. Another hypothetical regulatory mechanism is epigenetic differences which are not dynamically modifiable by androgen exposition. Difference in cardiovascular morbidity between men and women is well known, but there is considerable confusion if and how radical changes of sex hormone levels affects the function of the cardiovascular system both with acute and chronic exposure. Radical change of estrogen and testosterone levels can also affect the risk for metabolic disorders (lipid, carbohydrate and protein metabolism) which can cause hazard for both metabolic diseases such as diabetes and cardiovascular disease in the long term but also be a risk for future muscle weakness and osteoporosis. Effects on the central nervous system as a result of changes of sex hormone profile are not well known. However, we have several observations indicating that changes in sex hormone levels have visual effects (shown by MRI and PET) on distinctive features of the central nervous system.
Therefore, we will follow these patients for a year to study how the heart, blood vessels, brain, and risk factors for cardiovascular disease affected by altered sex hormone patterns and studying what happens in the muscles and fat in both the short and long term with respect to particular gene expression and epigenetic changes and link it to metabolic changes and body composition. Forty volunteers with gender dysphoria, 20 MtF and 20 FtM, are studied before the onset of sex hormone therapy, after a four-week shutdown of endogenous sex hormones and during one year of sex hormone treatment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 14186
- Karolinska Institutet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Otherwise healthy
Exclusion Criteria:
- Infectious disease
- Treatment with Warfarin or other anti coagulants.
- History of cardiovascular disease.
- Serious illness or mental disorder.
- Diabetes type 1
- Language difficulties
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Men with gender dysphoria
Genetic men treated with estrogen
|
Observational during estrogen treatment
|
Women with gender dysphoria
Genetic women treated with androgen
|
Observational during androgen treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiological changes in peripheral tissues
Time Frame: 5 years
|
Expression level and changes in epigenetics in skeletal muscle, skin and adipose tissue and associate to metabolism, insulin sensitivity, muscle strength, adipokines and adipose tissue morphology changes and body composition.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arterial stiffness, endothelial function and structural and functional effects of the heart
Time Frame: 5 years
|
5 years
|
Regulation of skeletal muscle mass and fat tissue with effect on body composition
Time Frame: 5 years
|
5 years
|
Systemic immune system changes
Time Frame: 5 years
|
5 years
|
Metabolic changes in the regulation of glucose homeostasis and lipid metabolism
Time Frame: 5 years
|
5 years
|
Morphological and functional effects on discrete areas of the brain
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna M Wiik, PhD, Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KI GETS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Transsexualism
-
Curtin UniversityBeyondblue (The National Depression Initiative)Completed
-
Medical University of ViennaCompleted
-
University Hospital, GhentOrganonCompleted
-
Max-Planck-Institute of PsychiatryUniversity of Erlangen-Nürnberg Medical School; Institute for Sex Research... and other collaboratorsCompletedTranssexualismGermany
-
Medical University of ViennaCompleted
-
Unita Complessa di Ostetricia e GinecologiaSchering-PloughCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloRecruitingHematologic Diseases | Transsexualism | TestosteroneBrazil
-
Medical University of GrazRecruitingGender Dysphoria | Body Image | Sexuality | Transsexualism | Gender Identity DisorderAustria
-
Universitätsklinikum Hamburg-EppendorfCompletedGender Dysphoria | Gender Identity | Transsexualism | Gender Identity Disorder | Gender IncongruenceGermany
-
Universitätsklinikum Hamburg-EppendorfUnknownGender Dysphoria | Gender Identity | Transsexualism | Gender Identity DisorderGermany
Clinical Trials on Genetic men treated with estrogen
-
Beckman Coulter, Inc.Completed
-
Centers for Disease Control and PreventionNew York Blood Center; The New York Academy of MedicineCompletedHIV InfectionsUnited States
-
Yuan-hong GaoCompletedNasopharyngeal Carcinoma
-
Reykjavik UniversityThe Icelandic Research Fund; The Icelandic Cancer SocietyCompleted
-
University of VirginiaNot yet recruitingGenetic Predisposition | Gene Mutation-Related Cancer
-
Philipps University Marburg Medical CenterCompleted
-
Johns Hopkins UniversityNational Human Genome Research Institute (NHGRI)Enrolling by invitationGenetic Counseling | Inherited Cardiac DiseaseUnited States
-
Endo PharmaceuticalsCompletedEdematous Fibrosclerotic PanniculopathyUnited States
-
Henry Ford Health SystemRecruiting