Evidence map›Paper›PMID 39788783›Full record

Observational studyBMJ open2025

Sex hormone-dependent host-microbiome interactions and cardiovascular risk (XCVD): design of a longitudinal multi-omics cohort study.

Kristina Franz, Lajos Markó, Anja Mähler, Rima Chakaroun, Sascha Heinitz, Haiko Schlögl, Julia Sacher, Nico Steckhan, Ralf Dechend, Noah Adams and 5 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05334888 (Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05334888 recruitingnot on this map

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

Typeobservational_patient_registrySponsorCharite University, Berlin, GermanyRan2022 to 2030Enrolled200ConditionsTransgender, Gut Microbiome, Immune System, Cardiovascular Risk Factors
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Kristina FranzExperimental and Clinical Research Center, Charité - Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine, Berlin, Germany kristina.franz@charite.de.ORCID http://orcid.org/0000-0002-3819-9671
Lajos MarkóExperimental and Clinical Research Center, Charité - Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine, Berlin, Germany.
Anja MählerExperimental and Clinical Research Center, Charité - Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine, Berlin, Germany.
Rima ChakarounMedical Department III Endocrinology Nephrology Rheumatology, University of Leipzig Medical Center, Leipzig, Germany.
Sascha HeinitzMedical Department III Endocrinology Nephrology Rheumatology, University of Leipzig Medical Center, Leipzig, Germany.
Haiko SchlöglMedical Department III Endocrinology Nephrology Rheumatology, University of Leipzig Medical Center, Leipzig, Germany.
Julia SacherClinic for Cognitive Neurology, University of Leipzig Medical Center, and Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, Max-Planck-Institut fur molekulare Physiologie, Dortmund, Germany.
Nico SteckhanDigital Health - Connected Healthcare, Hasso Plattner Institute, University of Potsdam, Potsdam, Germany.
Ralf DechendExperimental and Clinical Research Center, Charité - Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine, Berlin, Germany.
Noah AdamsUniversity of Toronto, Toronto, Ontario, Canada.
Marianne AndersenDepartment of Endocrinology, Odense Universitetshospital, Odense, Denmark.
Dorte GlintborgInstitute of Clinical Research, University of Southern Denmark, Odense, Syddanmark, Denmark.
Martin ViehwegerViRo, Berlin, Germany.
Lina Samira Bahr *Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine, Berlin, Germany.
Sofia Kirke Forslund-Startceva *Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine, Berlin, Germany.ORCID http://orcid.org/0000-0003-4285-6993

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCardiovascular 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 Charité 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.

Indexed as

Cardiovascular DiseasesGastrointestinal MicrobiomeGonadal Steroid HormonesAdultFemaleGender-Affirming ProceduresHeart Disease Risk FactorsHost Microbial InteractionsHumansLongitudinal StudiesMaleMultiomicsResearch DesignTransgender PersonsGonadal Steroid HormonesBIOTECHNOLOGY & BIOINFORMATICSCardiovascular DiseaseMICROBIOLOGYMOLECULAR BIOLOGYNutritionTransgender Persons

Identifiers

PMID39788783
PMCPMC11751863

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.