Neuroactive Sex Steroids And Their Influence In Glutamatergic Neurotransmission - Effects in Memory and Cognition in Transgender People
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glutamate concentration in the left hippocampus
研究概览
简要总结
Transgender women (male-to-female) were invited to participate in this study to test the impact of Cross-Sex Hormone Therapy (CSHT) in the brain.
Neuroimaging and cognitive assessment were performed in different time-points to compare the impact of CSHT in the brain.
详细描述
Sex hormones are known to exert several effect on the brain white matter, cerebral cortex, functional connectivity and neurotransmission. Furthermore, in transgender people, CSHT is know to induce anatomical and functional changes in the brain. However, only a few studies have already been conducted to investigate the effects of sex hormones on the brain accounting for the interference of endogenous gonadal hormones. Also, there is a lack of knowledge about the importance of CSHT after Gender Affirming Surgery (GAS) regarding induced hypogonadism that follows this surgical procedure. Therefore, neuroimaging studies designed to isolate the effect of endogenous gonadal hormones in people with GD urge to be developed.
To fulfil this purpose, transgender women that have already performed GAS and/or were under Gonadotrophin Release Hormone analogues treatment (in order to induce hypogonadism similar to GAS) were invited to interrupt CSHT for at least 30 days to promote sex hormones washout. At the end of the washout, participants performed magnetic resonance imaging, laboratorial analyses for sex hormones and neuro-cognitive assessment. After this first time-point, participants received a new prescription for CSHT containing estradiol (without progesterone) to be used continuously for 60 days, when the same assessments from the end of washout were repeated 60 days after CSHT to compare brain and cognitive longitudinal changes.
At all the time-points, variations in depression scores and anxiety levels were assessed with specific scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Transgender women
- •Age 18 to 60 years old.
排除标准
- •Use of psychostimulant drugs
- •Use of Antidepressive, Mood Stabiliser, Anti-psychotic, Benzodiazepines, anti-convulsivants, Anorexigenic
- •Endocrinological disease (other than diabetes)
- •Arterial Hypertensive Disease of Diabetes Mellitus out of control target
- •Neurological disease, including stroke or recent cranial trauma with loss or consciousness
- •HIV with low CD4 or high viral charge or symptomatic AIDS
- •Neoplasia
研究组 & 干预措施
Transgender Women
Transgender women who already completed GAS or that agreed to start gonadotropin release hormone analogue to suppress endogenous sex hormones.
If the participants were using CSHT in the moment of the study assignment, they were asked to stop hormones for 30 days to evaluate the impact of hypogonadism in the brain.
After this first assessment, they received prescriptions for Estradiol (equine conjugated oestrogen, or estradiol valerate, or topic 17-beta estradiol formulations) for 60 days, and the impact of CSHT was evaluated again to compare to washout condition.
干预措施: Estradiol (Drug)
结局指标
主要结局
Glutamate concentration in the left hippocampus
时间窗: 90 days
Proton Spectroscopy - magnetic resonance imaging; Glutamate concentration in the left hippocampus will be primarily correlated to working memory scores.
次要结局
- Cortical Thickness(90 days)
- functional connectivity(90 days)
- Diffusion track imaging(90 days)
- Cognition(90 days)
- Glutamate concentration in the anterior cingulate cortex and left dorsolateral prefrontal cortex(90 days)
- Language (Verbal Fluency)(90 days)
- Operational memory(90 days)
- Verbal memory(90 days)
- Executive function(90 days)