Body Composition Adaptations Following Initiation of Gender-Affirming Hormone Therapy in Transgender Populations.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Examine the increase in skeletal muscle mass after one year of testosterone treatment on body composition in transgender men using bioelectrical impedance vector analysis.
研究概览
简要总结
Gender-affirming hormone therapy (GAHT) is a fundamental component of medical transition in transgender men, promoting body composition changes that align physical characteristics with gender identity and alleviate gender dysphoria. In adults, GAHT typically involves testosterone administration, whereas adolescents may receive gonadotropin-releasing hormone agonists to suppress puberty before initiating testosterone.
Despite its general safety when appropriately monitored, findings on GAHT-related changes in body composition and potential cardiovascular implications are inconsistent. Accurate assessment of skeletal muscle mass and fat redistribution is clinically relevant, as conventional anthropometric measures may fail to capture these changes.
This study evaluates body composition changes after one year of testosterone therapy in transgender men using bioelectrical impedance vector analysis (BIVA), and explores the utility of muscle ultrasound as an accessible tool for monitoring skeletal muscle and potential differences among testosterone formulations.
详细描述
Gender-affirming hormone therapy (GAHT) is a central component of medical transition in transgender men, and aims to induce body composition changes that align physical appearance with gender identity and reduce gender dysphoria. In adults, GAHT typically consists of testosterone administration, whereas, in adolescents, gonadotropin-releasing hormone agonists (GnRHa) may be used to suppress puberty before initiating testosterone. GAHT has been associated with improvements in psychological well-being, social integration, and quality of life, although evidence remains limited due to the lack of randomized clinical trials. Moreover, body composition changes have been linked to psychological health in this population.
GAHT is considered safe when adequately monitored and individualized according to cardiovascular risk profile and pre-existing conditions. However, current evidence regarding its effects on body composition and potential implications for cardiovascular risk is inconsistent. Clinically, it is particularly relevant to determine the extent to which GAHT supports gains in skeletal muscle mass and fat redistribution, given their influence on body satisfaction and cardiometabolic risk. Importantly, relying on basic anthropometric measures such as body weight may lead to an underestimation of cardiovascular risk by failing to capture changes in key body compartments.
Reference techniques such as DXA or magnetic resonance imaging have been used to characterize these changes, although their limited accessibility restricts their routine application in clinical follow-up. In this context, bioelectrical impedance vector analysis (BIVA) and muscle ultrasound emerge as accessible alternatives for assessing skeletal muscle mass. However, the lack of population-specific reference values may hinder interpretation, underscoring the need to develop dedicated standards and validate these methods in transgender populations.
To examine the effect of one year of testosterone treatment on body composition in transgender men, different parameters will be assessed using BIVA. Additionally, the utility of muscle ultrasound as a feasible tool for monitoring skeletal muscle during masculinization will be explored, as well as if there are differences in body composition between different types of testosterone formulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Transgender men with confirmed gender dysphoria according to DSM-V criteria by an experienced sexologist.
- •Testosterone-naïve status
- •≥14 years
- •Absence of prior or planned mastectomy or genital surgery during the study period
排除标准
- •Diagnosed eating disorders, severe illness, neuromuscular or malignant disease, cardiovascular disease, and/or diabetes mellitus
- •Conditions contraindicating bioelectrical impedance analysis (pregnancy, lactation, or pacemaker)
- •Started GAHT prior to inclusion.
结局指标
主要结局
Examine the increase in skeletal muscle mass after one year of testosterone treatment on body composition in transgender men using bioelectrical impedance vector analysis.
时间窗: 5 years
To assess if there is a significant skeletal muscle mass gain after one year of testosterone treatment, skeletal muscle mass will be predicted using predictive equations with both resistance and resistence measured using bioelectrical impedance vector analysis. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval.
Explore the utility of muscle ultrasound as a feasible tool for monitoring skeletal muscle during masculinization hormonal treatment
时间窗: 5 years
Muscle ultrasound will be performed on a subsample using a DP-50 Expert Mobile Ultrasound System (Mindray®) equipped with a 5-10 MHz linear transducer. Examinations will be conducted at baseline, 6 months, and 12 months. Participants will be positioned supine with legs extended and instructed to refrain from exercise for at least 30 minutes before testing. Images will be obtained at the midpoint between the anterior superior iliac spine and the patella. Bilateral quadriceps muscle thickness (right and left; RQU and LQU) will be measured as the distance between the superficial and deep aponeuroses. Thickness of the rectus femoris and vastus intermedius will be recorded along the transverse axis. To check if RQU and LQU can predict skeletal muscle mass gain, regression models will be performed (square R coefficient \> 0,6). Acceptable sensitivity and specificity from RQU and LQU as predictors of skeletal muscle mass will be considered if their values are above 70%.
Assess significant changes in skeletal muscle mass gain according to type of testosterone formulation used
时间窗: 5 years
Skeletal muscle mass gain will be assessed by calculating the difference between final and baseline values obtained from body composition evaluations. Significant differences between types of testosterone formulations will be considered when notable differences in mean values between groups are observed, as determined by a p-value \< 0.05 using multiple pairwise comparisons followed by post hoc analysis, with a 95% confidence interval.
次要结局
- Evaluate significant changes in visceral fat after one year of testosterone treatment(4 years)
- Quantify skeletal muscle mass gain through one year of testosterone treatment(4 years)
- Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after one year of testosterone treatment.(4 years)
- Evaluate if there is a significant reduction after one year of testosterone treatment in HOMA-IR levels.(4 years)
- Analyze the changes in ApoB/ApoA1 ratio after one year of gender-affirming hormone therapy.(4 years)
- Evaluate significant changes in anti-mullerian hormone levels after one year of testosterone treatment.(4 years)
- Evaluate the changes in inhibin B levels after one year of gender-affirming hormone therapy.(4 years)
- Evaluate significant changes in hand grip strength after one year of testosterone treatment.(5 years)
研究者
Celia Bañuls
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana