Investigation of the Effects of Testosterone and Estrogen on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System in Transsexual Patients Undergoing Cross-sex Hormone Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Energy expenditure
研究概览
简要总结
Current study aims to characterize five highly interconnected physiological systems in patients undergoing cross-sex hormone therapy - namely glucose and lipid metabolism, energy balance, eating behavior, functional brain networks involved in the regulation of eating behavior and the cardiovascular system - to gain novel insights into the effects of sex hormones on the human body. Gathered information will help to identify pathophysiological mechanisms for the development of overeating/obesity, insulin resistance, and cardiovascular disease. Secondarily, the relationships between the gut and oral microbiomes and metabolomes and circulating bacterial signatures will be investigated in relation to the other pervasive physiological systems.
Current study is an observational study. The decision if the patient's request for cross-sex hormone therapy can complied with (i.e., if cross-sex hormone therapy is medically indicated) is made prior to the first contact with the study center and with the outpatients clinic for Endocrinology at the University Hospital in Leipzig. Decision ifor treatment is made according to national and international guidelines. Treatment of study participants with testosterone and estradiol/antiandrogens is not affected by the study. During the course of the study no invasive interventions are being performed.
详细描述
- Introduction 1.1. Transsexualism Transsexualism is a condition in which an individual's gender identity is incongruent with the assigned sex at birth. Many transsexuals suffer from severe psychological problems caused by this this incongruence, referred to as gender dysphoria. Supporting transsexuals in living in the sex with which they identify leads to amelioration of psychological problems and medical problems. In sex reassignment therapy, cross-sex hormone therapy is an essential element.
1.2. Cross-sex hormone therapy in transsexual patients In many patients, cross sex hormone therapy is used to conduct sex change. In transmen (biological women with perceived male sex), testosterone is used for gender reassignment. In transwomen (biological men with perceived female sex), the most commonly used medication is estrogen. Successful therapy leads to the development of typical secondary sex characteristics. Data and knowledge regarding the effects of cross-sex hormone therapy on the human body, additionally to the desired sex affirming changes, is scarce.
1.3. Investigation of the effects of estrogen and testosterone on the human body Investigating the effects of cross-sex hormone therapy provides further information on the effects of testosterone and estradiol on the human body. One of the most recognized differences between men and women regarding health is the increased cardiovascular risk of men as compared to women. In transmen, testosterone therapy leads to an increased risk for myocardial infarction. Data from the diabetes prevention program suggest that in males the probability of developing diabetes mellitus type 2, a major risk factor for cardiovascular disease is positively correlated with serum concentrations of estradiol and negatively correlated with concentrations of testosterone. Furthermore, previous studies pointed to differences in the regulation of eating behavior of men and women potentially contributing to the development of obesity and type-2-diabetes.
Moreover, while the microbiota, known to affect host homeostasis, immunity, and metabolism, shows sex-related variations, the impact of sex hormones and gender transition on the different microbiome niches and related metabolic processes, remains largely unexplored.
The above mentioned findings are just examples of plentiful dissimilarities in health and disease of the two sexes with unknown causes. To date studies assessing e.g. markers of cardiometabolic disease in cross-sex hormone therapy remain inconclusive.
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
- •transsexual patients undergoing cross-sex hormone therapy versus controls
- •able to give informed consent, if <18 years from all legal guardians
- •only for part B (patients will participate in all other study parts): weight stable (± 5%) for last 3 months, BMI ≤ 30 kg/m2
排除标准
- •severe medical impairments (e.g., uncontrolled cardiovascular disease, severe heart failure, uncontrolled hypertension, cerebral insult, active malign disease, etc.)
- •self-initiated cross-sex hormone therapy before study start only for part B (patients will participate in all other study parts): Insufficiently controlled endocrine disorders (Cushing's disease, other uncontrolled pituitary disorders, uncontrolled hypothyroidism, hyperthyroidism, etc.)
- •Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only will be allowed to enter the study (provided use of these agents is not required for 1 week before
- •Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study entry).
- •History of HIV infection or ongoing chronic infection (such as tuberculosis)
- •only for part D (patients will participate in all other study parts): Contraindication against performance of an MRI scan (i.e., presence of metal in body, tattoos in head/neck region, claustrophobia etc.)
结局指标
主要结局
Energy expenditure
时间窗: up to one year
To examine short-term and longer-term effects of cross-sex hormone therapy on changes in resting energy expenditure (kcal/d).
Weight change
时间窗: up to one year
To examine short-term and longer-term effects of cross-sex hormone therapy on weight change (change from baseline in kg).
Vascular stiffness
时间窗: up to five years
To examine short-term and longer-term effects of cross-sex hormone therapy on changes in vascular stiffness (change from baseline using cm/s to assess arterial stiffness).
Insulin sensitivity
时间窗: up to five years
To examine short-term and longer-term effects of cross-sex hormone therapy on changes in insulin sensitivity (change from baseline using HOMA-IR to assess insulin sensitivity).
Food intake
时间窗: up to one year
To examine short-term and longer-term effects of cross-sex hormone therapy on changes ad libitum food intake (change from baseline in kcal).
次要结局
- Olfaction(up to five years)
- Gut, oral and circulating microbiomes and metabolomes(up to five years)
- Taste perception(up to five years)
研究者
Sascha Heinitz
Principal investigator
University of Leipzig