Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach
XCVD
Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedStudy Start
First participant enrolled
August 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedFebruary 9, 2024
February 1, 2024
3.3 years
April 4, 2022
February 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in relative species abundance of intestinal bacteria compared
baseline and 2 years after initiation of hormone replacement therapy. stool samples: Analysis with 16s rRNA sequencing
Baseline, 2 years Follow Up (optional: after 1 year Follow Up)
Secondary Outcomes (25)
Changes in cardio marker
Baseline, 2 years Follow Up (optional: after 1 year Follow Up)
Changes in hormone parameters
Baseline, 2 years Follow Up (optional: after 1 year Follow Up)
Changes in immune marker
Baseline, 2 years Follow Up (optional: after 1 year Follow Up)
Changes in the concentration of of cortisol, progesterone, testosterone and dehydroepiandrosterone
Baseline, 2 years Follow Up
Changes in the oral species abundance
Baseline, 2 years Follow Up (optional: after 1 year Follow Up)
- +20 more secondary outcomes
Eligibility Criteria
Healthy transgender individuals during their gender hormone replacement therapy (HRT)
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Experimental and Clinical Research Center, Clinical Research Unit
Berlin, 13125, Germany
Related Publications (3)
Fromentin S, Forslund SK, Chechi K, Aron-Wisnewsky J, Chakaroun R, Nielsen T, Tremaroli V, Ji B, Prifti E, Myridakis A, Chilloux J, Andrikopoulos P, Fan Y, Olanipekun MT, Alves R, Adiouch S, Bar N, Talmor-Barkan Y, Belda E, Caesar R, Coelho LP, Falony G, Fellahi S, Galan P, Galleron N, Helft G, Hoyles L, Isnard R, Le Chatelier E, Julienne H, Olsson L, Pedersen HK, Pons N, Quinquis B, Rouault C, Roume H, Salem JE, Schmidt TSB, Vieira-Silva S, Li P, Zimmermann-Kogadeeva M, Lewinter C, Sondertoft NB, Hansen TH, Gauguier D, Gotze JP, Kober L, Kornowski R, Vestergaard H, Hansen T, Zucker JD, Hercberg S, Letunic I, Backhed F, Oppert JM, Nielsen J, Raes J, Bork P, Stumvoll M, Segal E, Clement K, Dumas ME, Ehrlich SD, Pedersen O. Microbiome and metabolome features of the cardiometabolic disease spectrum. Nat Med. 2022 Feb;28(2):303-314. doi: 10.1038/s41591-022-01688-4. Epub 2022 Feb 17.
PMID: 35177860RESULTTalmor-Barkan Y, Bar N, Shaul AA, Shahaf N, Godneva A, Bussi Y, Lotan-Pompan M, Weinberger A, Shechter A, Chezar-Azerrad C, Arow Z, Hammer Y, Chechi K, Forslund SK, Fromentin S, Dumas ME, Ehrlich SD, Pedersen O, Kornowski R, Segal E. Metabolomic and microbiome profiling reveals personalized risk factors for coronary artery disease. Nat Med. 2022 Feb;28(2):295-302. doi: 10.1038/s41591-022-01686-6. Epub 2022 Feb 17.
PMID: 35177859RESULTFranz K, Marko L, Mahler A, Chakaroun R, Heinitz S, Schlogl H, Sacher J, Steckhan N, Dechend R, Adams N, Andersen M, Glintborg D, Viehweger M, Bahr LS, Forslund-Startceva SK. Sex hormone-dependent host-microbiome interactions and cardiovascular risk (XCVD): design of a longitudinal multi-omics cohort study. BMJ Open. 2025 Jan 9;15(1):e087982. doi: 10.1136/bmjopen-2024-087982.
PMID: 39788783DERIVED
Related Links
Biospecimen
Sera Plasma Whole blood Feces Saliva Hair Skin
Study Officials
- STUDY DIRECTOR
Sofia Forslund, Dr.
Max-Delbrück-Center
- PRINCIPAL INVESTIGATOR
Lajos Marko
Charite - Universitätsmedizin Berlin
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 19, 2022
Study Start
August 29, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
February 9, 2024
Record last verified: 2024-02