RecruitingNCT05334888

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.


Sponsor

Charite University, Berlin, Germany

Enrollment

200 participants

Start Date

Aug 29, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

  • 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 Criteria2

  • 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.

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Locations(1)

Experimental and Clinical Research Center, Clinical Research Unit

Berlin, Germany

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NCT05334888


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