Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach (XCVD)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Gut Microbiome; Transgender; Cardiovascular Risk Factors; Immune System

Study type: Observational

Funder types: Other

Identifiers

NCT05334888

ChariteU - ECRC XCVD

Details and patient eligibility

About

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 two 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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.