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Recruiting NCT05334888

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

— Observational Transgender Gut Microbiome Immune System Cardiovascular Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Transgender, Gut Microbiome, Immune System, Cardiovascular Risk Factors. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.

Overview

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.

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.

Primary outcome measures

  • Changes in relative species abundance of intestinal bacteria compared [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
Secondary outcome measures (12)
  • Changes in cardio marker [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in hormone parameters [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in immune marker [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in the concentration of of cortisol, progesterone, testosterone and dehydroepiandrosterone [Time frame: Baseline, 2 years and 5 years Follow Up (optional: one year follow up)]
  • Changes in the oral species abundance [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in Immune cell marker / regulatory T-cells [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in Epigenomics [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in Proteomics [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in Metabolomics [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in relative species abundance of skin microbioma [Time frame: Baseline, 2 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in BMI [Time frame: Baseline, 2 years Follow Up (optional: after 1 year Follow Up)]
  • Changes in circumference [Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Experimental and Clinical Research Center, Clinical Research Unit — Berlin

Publications

  • 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, Ro PMID 35177860
  • Talmor-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. PMID 35177859
  • Franz 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 39788783

Identifiers

NCT: NCT05334888 · ChariteU - ECRC XCVD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗