GEnder Dysphoria Treatment in Sweden
GETS
Phenotype Modulations Following Treatment With Contrary Sex Hormones
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
August 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJune 10, 2022
June 1, 2022
6.7 years
May 12, 2015
June 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Physiological changes in peripheral tissues
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 Outcomes (5)
Arterial stiffness, endothelial function and structural and functional effects of the heart
5 years
Regulation of skeletal muscle mass and fat tissue with effect on body composition
5 years
Systemic immune system changes
5 years
Metabolic changes in the regulation of glucose homeostasis and lipid metabolism
5 years
Morphological and functional effects on discrete areas of the brain
5 years
Study Arms (2)
Men with gender dysphoria
Genetic men treated with estrogen
Women with gender dysphoria
Genetic women treated with androgen
Interventions
Observational during estrogen treatment
Observational during androgen treatment
Eligibility Criteria
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.
You may qualify if:
- Otherwise healthy
You may not qualify if:
- Infectious disease
- Treatment with Warfarin or other anti coagulants.
- History of cardiovascular disease.
- Serious illness or mental disorder.
- Diabetes type 1
- Language difficulties
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Region Stockholmcollaborator
Study Sites (1)
Karolinska Institutet
Stockholm, 14186, Sweden
Related Publications (2)
Subramanian N, Wiik A, Rullman E, Melin M, Lundberg TR, Flanagan J, Holmberg M, Dekanski A, Dhejne C, Arver S, Gustafsson T, Laurencikiene J, Andersson DP. Adipokine secretion and lipolysis following gender-affirming treatment in transgender individuals. J Endocrinol Invest. 2024 Sep;47(9):2249-2260. doi: 10.1007/s40618-024-02323-4. Epub 2024 Mar 9.
PMID: 38460092DERIVEDWiik A, Lundberg TR, Rullman E, Andersson DP, Holmberg M, Mandic M, Brismar TB, Dahlqvist Leinhard O, Chanpen S, Flanagan JN, Arver S, Gustafsson T. Muscle Strength, Size, and Composition Following 12 Months of Gender-affirming Treatment in Transgender Individuals. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz247. doi: 10.1210/clinem/dgz247.
PMID: 31794605DERIVED
Biospecimen
Tissue samples from blood, skin, muscle and fat
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna M Wiik, PhD
Karolinska Institutet
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
May 12, 2015
First Posted
August 7, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2021
Study Completion
May 1, 2022
Last Updated
June 10, 2022
Record last verified: 2022-06