North Jersey Community Research Initiative (NJCRI) Study on Transgender Liver Health
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assess disparities in liver health outcomes among transgender individuals
研究概览
简要总结
Primary Objective:
Assess disparities in liver health outcomes among transgender individuals on GAHT by evaluating liver function markers (transaminases, bilirubin levels, etc), as well as liver elasticity and presence of liver steatosis or Nonalcoholic Fatty Liver Disease (NAFLD) through FibroScan. A total of 60 participants will be recruited throughout the study, with a ratio of 1:1 between transgender participants who have been on GAHT more than 6 months ( = or > 182 days), and transgender participants who have been on GAHT for less than 6 months ( < 181 days) at the start of the study.
Secondary Objectives:
Assess liver health-related risk factors (e.g. obesity, alcohol consumption) in transgender population.
Investigate the association between specific hormone regimens and liver function in transgender individuals.
Explore potential modifiers of liver health outcomes, such as age, social barriers determinants of health, duration of hormone therapy and adherence to medical guidelines.
Change in Quality of Life from baseline to last study visit.
详细描述
Gender-affirming hormone therapy (GAHT) plays a crucial role in the healthcare of transgender individuals, aligning their physical characteristics with their gender identity. GAHT has been recognized for its positive impact on mental health and well-being of transgender individuals. Research consistently demonstrates that a GAHT is associated with improvement in gender dysphoria, psychological distress and overall quality of life. Hormone therapy facilities the alignment of physical characteristics with gender identity, alleviating feelings of gender incongruence and enhancing self-esteem and body satisfaction. Additionally, GAHT has been shown to reduce symptoms of depression, anxiety, providing transgender individuals with opportunity to live authentically and comfortably in their affirmed gender. These findings underscore the importance of access to comprehensive transgender healthcare, including hormone therapy, in promoting the mental health and well-being of transgender population.
Extant literature supports the conclusion that GAHT improves various aspects of mental health and quality of life for transgender people. Additional, though limited, research exploring the physical effects of GAHT suggests that GAHT may have both positive and negative effects on metabolism, bone health, cardiovascular health, and cancer risk. However, the impact of GAHT on liver health remains a topic of ongoing investigation. Some studies suggest that GAHT may influence liver function markers, potentially increasing the risk of liver-related complications, though results are mixed on the clinical significance . Understanding these effects is essential for optimizing the healthcare of transgender populations and ensuring the safety and efficacy of hormone therapy regimens.
NJCRI, having an established gender affirming care clinic since 2017, is interested in studying the liver health in our transgender population. Our aim is to identify risk factors that can affect liver health in this community.
STUDY DESIGN:
This is an observational prospective case-control study conducted at NJCRI over a period of 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Transgender individuals (18 years or older).
- •Individuals who are able to write and/or read in English. -
排除标准
- •Inability to provide informed consent
- •Individuals with known decompensated liver cirrhosis.
研究组 & 干预措施
Transgender >6 months on GAHT and Transgender <6 months on GAHT
A total of 60 participants will be recruited throughout the study, with a ratio of 1:1 between transgender participants who have been on GAHT more than 6 months ( = or > 182 days), and transgender participants who have been on GAHT for less than 6 months ( < 181 days) at the start of the study
结局指标
主要结局
Assess disparities in liver health outcomes among transgender individuals
时间窗: Baseline through December 2027
Assess disparities in liver health outcomes among transgender individuals
Assess Elasticity of liver
时间窗: Baseline through December 2027
GAHT by evaluating liver function markers by Fibroscan
次要结局
- Assess Liver Health Risk Factors(baseline to December 2027)
- Liver function in Transgender individuals(baseline to December 2027)
- Explore potential modifiers of liver health outcomes(baseline to December 2027)
- Change in Quality of Life at baseline visit(baseline to December 2027)
- Change in Quality of Life at last visit(baseline to December 2027)
研究者
Corey DeStefano
Director of Research
North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)