Clinical Trial: GEnder Dysphoria Treatment in Sweden

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Phenotype Modulations Following Treatment With Contrary Sex Hormones

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.


Detailed Summary:

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 exposit
Sponsor: Karolinska Institutet

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: May 12, 2015
Date Started: April 2015
Date Completion: April 2020
Last Updated: September 8, 2016
Last Verified: August 2016