Sex-differential Host-microbiome CVD Risk – A Longitudinal Cohort Approach

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Description

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.

Study Overview

Start Date
August 29, 2022
Completion Date
December 31, 2027
Enrollment
200
Date Posted
April 19, 2022
Gender
All

Locations

Full Address
Experimental and Clinical Research Center, Clinical Research Unit
Berlin 13125, Germany

Eligibility

Study Population
Healthy transgender individuals during their gender hormone replacement therapy (HRT)
Minimum Age (years)
18
Maximum Age (years)
50
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.

Study Contact Info

Study Contact Name
Sofia Forslund, Prof. Dr.; Lajos Marko, Dr.
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
Conducting this innovative study using established scientific methods such as omics platforms, systems biology, and careful CVD phenotyping will allow, for the first time, extensive data collection on the influence of sex hormones on the development of CVD risk factors as well as the role of the gut microbiome. In doing so, the influence of circulating sex hormones can also be quantified to potentially predict CVD risk markers.
NCTid (if applicable)
NCT05334888