None listed
Conditions
Brief summary
Biological differences between males and females are well known in terms of reproductive functioning. However, it is becoming increasingly well recognised that non-communicable chronic diseases, such as diabetes, cardiovascular disease, and many neurological and mental health disorders display sexual dimorphisms in their pathogenesis and presentation. Females are somewhat protected against both the development of insulin resistance and cardiovascular disease compared with males of a similar age. However, this difference between sexes diminishes after women reach menopause. Much of this sexual dimorphism has been attributed to the regulatory effects of the steroid sex hormones testosterone, oestrogen and progesterone. Cross-sex hormones (CSH) are a treatment option used to treat gender dysphoria (DSM V) and facilitate transition from their natal sex (i.e. sex assigned at birth) to their identified gender. Feminisation typically requires administration of androgen-blockers and co-administration of oestrogen hormones, whereas masculinisation requires administration of testosterone treatment. Treatment with CSH is usually lifelong. Evidence shows that transgender persons are at an increased risk of mental distress and chronic disease. In addition to the physical changes induced by cross-sex hormone therapy commonly associated with puberty (such as changes to body hair, skin appearance), cross-sex hormones have been shown to influence factors such as body composition. The overall effect of cross-sex hormone treatment on cardiovascular and diabetes risk is still unclear. Cross-sex hormone treatment has been reported to both improve and impair various CVD risk factors, such as fasting glucose and insulin levels, plasma docosahexaenoic acid (DHA) levels, adipokines and C-reactive protein. Studying the effect of cross-sex hormones on DHA status and other risk factors for CVD and diabetes in transgender persons undergoing hormone therapy allows a unique opportunity to investigate the contribution of sex hormones to the sexual dimorphisms apparent in both these conditions. Furthermore, investigating metabolic changes in response to cross-sex hormone treatment may help to inform dietary and/or pharmaceutical strategies for minimizing the health risks associated with receiving CSH in this at risk group. Therefore the aim of this observational study is to measure the effect of cross-sex hormone therapy on metabolic risk factors for both diabetes and CVD in transgender individuals undergoing hormone therapy.
Interventions
Potential participants will be invited to the study if they are scheduled to commence male-to-female (feminising) or female-to-male (masculinising) cross-sex hormone treatment. Cross-sex hormones are used to facilitate the gender affirmation process in transgender individuals. Feminising therapy initially begins with administration of androgen blockers, with oestrodiol (oral or transdermal) added after 6 - 12 weeks, with the dose titrated to maximal dose or until biochemical targets are met. Mas
Potential participants will be invited to the study if they are scheduled to commence male-to-female (feminising) or female-to-male (masculinising) cross-sex hormone treatment. Cross-sex hormones are used to facilitate the gender affirmation process in transgender individuals. Feminising therapy initially begins with administration of androgen blockers, with oestrodiol (oral or transdermal) added after 6 - 12 weeks, with the dose titrated to maximal dose or until biochemical targets are met. Masculinisng therapy involves adminstration of transdermal testosterone, beginning at 1/4 dose on alternating days and titrated up over 8-12 weeks until maximal dose is reached. After biochemical treatments are met, transition to injectable testosterone treatment may be considered. Treatments are individualised and may vary according to individual response. Study appointments will be before commencing treatment (baseline), 3 months, 6 months and 12 months. Each appointment will take 40-60 minutes to complete, and will be scheduled alongside the routine appointments with the Endocrinologist, At each time-point routine clinical measurements will be recorded (fasting glucose, blood lipid profile, FBC, LFT, & UEC ). In addition to these, the following outcomes will be measured: Body composition using biometric impedance analysis and dual-energy xray absorpiometry (DEXA); dietary intake, physical activity, and self-perceived health & wellbeing will be measured using questionnaires; and a small blood sample will be collected to measure fasting insulin, erythrocyte and plasma fatty acid profile, adipokines and inflammatory markers.
Sponsors
University of Newcastle
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants will be invited to join the study if they are: - Aged 18 years or older - Commencing cross-sex hormone treatment at John Hunter Hospital
Exclusion criteria
The following people will be excluded from volunteering from the study: - Children and young people less than 18 years - People who regularly consume more than 2 serves / week (250g) oily fish or taking fish oil capsules - People with an intellectual or mental impairment who cannot give informed consent
Outcome results
None listed