NCT05334888

Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach

Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Transgender
• Gut Microbiome
• Immune System
• Cardiovascular Risk Factors

Timeline

• Start date: 2022-08-29
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2022-04-19
• Last updated: 2024-02-09

Locations

1 site across 1 country: Germany