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Trial record 1 of 1 for:    NCT02518009
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GEnder Dysphoria Treatment in Sweden (GETS)

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ClinicalTrials.gov Identifier: NCT02518009
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : June 10, 2022
Sponsor:
Collaborator:
Region Stockholm
Information provided by (Responsible Party):
Thomas Gustafsson Assoc Prof, Karolinska Institutet

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Transsexualism Other: Genetic men treated with estrogen Other: Genetic women treated with androgen

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 Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phenotype Modulations Following Treatment With Contrary Sex Hormones
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2021
Actual Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Groups and Cohorts
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Group/Cohort Intervention/treatment
Men with gender dysphoria
Genetic men treated with estrogen
 Other: Genetic men treated with estrogen
Observational during estrogen treatment
Women with gender dysphoria
Genetic women treated with androgen
 Other: Genetic women treated with androgen
Observational during androgen treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Arterial stiffness, endothelial function and structural and functional effects of the heart [ Time Frame: 5 years ]
  2. Regulation of skeletal muscle mass and fat tissue with effect on body composition [ Time Frame: 5 years ]
  3. Systemic immune system changes [ Time Frame: 5 years ]
  4. Metabolic changes in the regulation of glucose homeostasis and lipid metabolism [ Time Frame: 5 years ]
  5. Morphological and functional effects on discrete areas of the brain [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Tissue samples from blood, skin, muscle and fat

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects that are under investigation for gender dysphoria that have been accepted but not yet started their treatment with contrary sex hormones are asked if they want to participate.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518009


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Region Stockholm
Investigators
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Principal Investigator: Anna M Wiik, PhD Karolinska Institutet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Gustafsson Assoc Prof, PhD, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02518009    
Other Study ID Numbers: KI GETS
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Estrogens
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs