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
Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Changes in relative species abundance of intestinal bacteria compared — Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) baseline and 2 years and 5 years after initiation of hormone replacement therapy.
stool samples: Analysis with 16s rRNA sequencing
Trial sites (1)
Facility
City
Region
Status
Experimental and Clinical Research Center, Clinical Research Unit
Berlin
Germany
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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