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Search / Trial NCT05334888

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

Transgender Medicine

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.

Locations

Berlin, , Germany

Patients applied

0 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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