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Sex hormone-dependent host-microbiome interactions and cardiovascular risk (XCVD): Design of a longitudinal multi-omics cohort study.
BMJ Open 15:e087982 (2025)
Introduction Cardiovascular diseases (CVDs) present differently in women and men, influenced by host-microbiome interactions. The roles of sex hormones in CVD outcomes and gut microbiome in modifying these effects are poorly understood. The XCVD study examines gut microbiome mediation of sex hormone effects on CVD risk markers by observing transgender participants undergoing gender-affirming hormone therapy (GAHT), with findings expected to extrapolate to cisgender populations. Methods and analyses This observational, longitudinal cohort study includes baseline, 1- and 2-year follow-ups with transgender participants beginning GAHT. It involves comprehensive phenotyping and microbiome genotyping, integrating computational analyses of high-dimensional data. Microbial diversity will be assessed using gut, skin, and oral samples via 16S rRNA and shotgun metagenomic sequencing of gut samples. Blood measurements will include sex hormones, CVD risk markers, cardiometabolic parameters, cytokines, and immune cell counts. Hair samples will be analysed for cortisol. Participants will complete online questionnaires on physical activity, mental health, stress, quality of life, fatigue, sleep, pain, and gender dysphoria, tracking medication use and diet to control for confounders. Statistical analyses will integrate phenomic, lifestyle, and multi-omic data to model health effects, testing gut microbiome mediation of CVD risk as the endocrine environment shifts between that typical for cisgender men to women and vice versa. Ethics and dissemination The study adheres to Good Clinical Practice and the Declaration of Helsinki. The protocol was approved by the Charit & eacute; Ethical Committee (EA1/339/21). Signed informed consent will be obtained. Results will be published in peer-reviewed journals and conferences and shared as accessible summaries for participants, community groups, and the public, with participants able to view their data securely after public and patient involvement review for accessibility. Trial registration number The XCVD study was registered on ClinicalTrials.gov (NCT05334888) as 'Sex-differential host-microbiome CVD risk - a longitudinal cohort approach (XCVD)" on 4 April 2022. Data set link can be found at https://classic.clinicaltrials.gov/ct2/show/NCT05334888.
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Publication type
Article: Journal article
Document type
Scientific Article
Keywords
Cardiovascular Disease; MICROBIOLOGY; Transgender Persons; MOLECULAR BIOLOGY; BIOTECHNOLOGY & BIOINFORMATICS; Nutrition; Transgender People; Health; Testosterone; Disease; Validation; Therapy; Events; Life; Men
ISSN (print) / ISBN
2044-6055
e-ISSN
2044-6055
Journal
BMJ Open
Quellenangaben
Volume: 15,
Issue: 1,
Article Number: e087982
Publisher
BMJ Publishing Group
Publishing Place
British Med Assoc House, Tavistock Square, London Wc1h 9jr, England
Non-patent literature
Publications
Reviewing status
Peer reviewed
Institute(s)
Helmholtz Institute for Metabolism, Obesity and Vascular Research (HI-MAG)
Grants
ECRC clinical study fund
Charite- Universitaetsmedizin Berlin
Charite- Universitaetsmedizin Berlin