Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach
Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Apr 13, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The XCVD study is looking at how hormone replacement therapy (HRT) affects the gut microbiome—this is the community of bacteria and other microorganisms living in our intestines—and how these changes might relate to heart health in transgender individuals. Over two years, researchers will follow 200 healthy transgender people aged 18 to 50 who are undergoing HRT, examining how their gut health might influence the risk of developing heart disease.
To participate in this study, individuals need to be between 18 and 50 years old, speak either German or English, and have previously received gender hormone therapy. Participants will need to provide written consent and have health insurance to cover any unexpected findings during the study. Throughout the trial, participants can expect regular check-ups and tests to monitor their health, specifically looking at their gut microbiome, immune system, and potential cardiovascular risk factors. This study aims to help us better understand the relationship between hormones, gut health, and heart disease, which could lead to improved healthcare for transgender individuals in the future.
Gender
ALL
Eligibility criteria
- 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.
About Charite University, Berlin, Germany
Charité - Universitätsmedizin Berlin is a leading academic medical center in Germany, renowned for its commitment to excellence in research, education, and patient care. As one of Europe's largest university hospitals, Charité integrates cutting-edge clinical practices with innovative research initiatives, fostering interdisciplinary collaboration across various medical fields. The institution is dedicated to advancing healthcare through rigorous clinical trials, contributing to the development of new therapies and treatment protocols. With a strong emphasis on translational medicine, Charité aims to bridge the gap between scientific discovery and practical application, ultimately enhancing patient outcomes and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Berlin, , Germany
Patients applied
Trial Officials
Sofia Forslund, Dr.
Study Director
Max-Delbrück-Center
Lajos Marko
Principal Investigator
Charite - Universitätsmedizin Berlin
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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