Changes in Energy Expenditure (EE) in Transsexuals Undergoing Hormonal Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- RESTING METABOLIC RATE
研究概览
简要总结
Examining Metabolic Rate in Transgender individuals before starting hormonal treatment and 6-12 months after initiation
详细描述
Study Objective
- To assess energy expenditure including: resting energy expenditure (RER), - in transgender subjects undergoing hormonal gender affirming treatment.
- To assess change in Physical Activity (PA) before and after treatment. Methods Study design: A pilot observational prospective study, recruiting 20 transsexuals: 10 transwomen (TW) and 10 transmen (TM).
Criteria for inclusion
- TW and TM with no prior hormonal therapy in the last one year.
- Stable weight in last six months (<±5% weight change),
Criteria for exclusion
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •TW and TM with no prior hormonal therapy in the last one year.
- •Stable weight in last six months (<±5% weight change),
排除标准
- •Postmenopausal TM.
- •Oral contraceptive use.
- •Pregnancy or breastfeeding.
- •Glucocorticosteroid treatment
- •Uncontrolled thyroid disorders
- •Use of drugs that potentially impact body metabolism
结局指标
主要结局
RESTING METABOLIC RATE
时间窗: 6-12 months
Methods Study design: A pilot observational prospective study, recruiting 34 transsexuals: 17 transwomen (TW) and 17 transmen (TM). Criteria for inclusion 1. TW and TM with no prior hormonal therapy in the last one year. 2. Stable weight in last six months (\<±5% weight change), Criteria for exclusion 1. Postmenopausal TM. 2. Oral contraceptive use. 3. Pregnancy or breastfeeding. 4. Glucocorticosteroid treatment 5. Uncontrolled thyroid disorders 6. Use of drugs that potentially impact body metabolism Follow up will be for 6 months. Baseline tests and after 3 and 6 months of treatment: 1. Anthropometrics: 1. Body weight will be measured to the nearest 10 g on a digital scale (Seca, 'mBCA') after 12 hours of overnight fast. 2. Height will be measured with a wireless digital stadiometer (Seca 274) to the nearest 0.1 cm at baseline. 3. Changes in body composition, including Fat and Fat Free Mass, will be evaluated by multi-frequency bioelectrical impedance analysis (BIA) after 12 hour
次要结局
未报告次要终点