Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in relative species abundance of intestinal bacteria compared
研究概览
简要总结
The XCVD study investigates the influence of sex hormones on the composition of the gut microbiome and the possible emergence of cardiovascular risk factors. It will follow 200 healthy transgender individuals for five years during their hormone replacement therapy (HRT) and analyze them for the possible emergence of cardiovascular risk factors in relation to changes in the gut microbiome, metabolome, and immunome. We would also like to phenotype cardiovascular disease.
详细描述
Conducting this innovative study using established scientific methods such as omics platforms, systems biology, and careful CVD phenotyping will allow, for the first time, extensive data collection on the influence of sex hormones on the development of CVD risk factors as well as the role of the gut microbiome. In doing so, the influence of circulating sex hormones can also be quantified to potentially predict CVD risk markers.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50
- •Language requirements: German, English
- •Previous gender hormone replacement therapy (HRT).
- •Ability to give consent and written consent to participate.
- •Health insurance (for clarification of incidental findings)
排除标准
- •Diseases or functional disorders that, in the opinion of the study physician, preclude participation in the study.
- •Incapacity or other circumstances that do not allow study participants to fully understand the nature, significance and scope of this study.
结局指标
主要结局
Changes in relative species abundance of intestinal bacteria compared
时间窗: Baseline, 2 years Follow Up (optional: after 1 year Follow Up)
baseline and 2 years after initiation of hormone replacement therapy. stool samples: Analysis with 16s rRNA sequencing
次要结局
- Changes in BMI(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in physical activity(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in quality of life(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in depression(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in cardio marker(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in Immune cell marker / regulatory T-cells(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in mental health(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in chrono type / sleep-wake behaviour(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in hormone parameters(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in immune marker(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in Perceived Stress(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in socio-demographics(Baseline, 2 years Follow Up)
- Documentation of HRT(Baseline - HRT start, 6, 12, 18 and 24 months Follow Up)
- Changes in the concentration of of cortisol, progesterone, testosterone and dehydroepiandrosterone(Baseline, 2 years Follow Up)
- Changes in Proteomics(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in dietary habits(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in CVD risk scores(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in the oral species abundance(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in Epigenomics(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in Metabolomics(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in relative species abundance of skin microbioma(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in circumference(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Gender identity(Baseline, 6, 12, 18 and 24 months Follow Up)
- Changes in vital signs(Baseline, 2 years Follow Up (optional: after 1 year Follow Up))
- Changes in life style risk parameters(Baseline, 2 years Follow Up)
研究者
Dr. Lajos Marko
Dr.
Charite University, Berlin, Germany