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NCT05334888
Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach
Conditions: Transgender, Gut Microbiome, Immune System, Cardiovascular Risk Factors
Sex: All
Ages: 18 Years – 50 Years
Enrollment: 200
Sponsor: Charite University, Berlin, Germany
Location: Experimental and Clinical Research Center, Clinical Research Unit Berlin
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 five 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 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.
Source: ClinicalTrials.gov (NCT05334888). StuddyBuddy aggregates publicly available trial information.