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NCT Number: NCT05334888

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

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.

Recruiting

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Key information

Conditions

Transgender Cardiovascular Risk Factors Gut Microbiome Immune System

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

    baseline and 2 years and 5 years after initiation of hormone replacement therapy.

    stool samples: Analysis with 16s rRNA sequencing

Secondary outcomes

  1. Changes in cardio marker

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    sera: following cardio marker can be determined by Electro Chemiluminescence Immuno-Assay: BNP and hs-troponin.

  2. Changes in hormone parameters

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    sera: following hormones can be determined by mass spectrometry: Free Androgen Index (fAI), Beta-CrossLaps (BCTX), Carboxy-terminal Propeptide of Procollagen I (P1CP), Luteinizing Hormone, Oestradiol, Progesterone, Testosterone, Free Testosterone, Sex Hormone Binding Globulin, Dihydrotestosterone, Oestron, Free Oestriol.

  3. Changes in immune marker

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    sera: pro- and anti-inflammatory cytokines using cytokine - multiplex panel and Immune cell populations with shotgun sequencing

  4. 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)

    Hair sample: Hair steroid analysis with Immunoassay and LC-MS/MS

  5. Changes in the oral species abundance

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    saliva sample / oral / mouth: species abundance of oral bacteria (sequencing)

  6. Changes in Immune cell marker / regulatory T-cells

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    Whole blood samples for Immune cell populations and peripheral blood mononuclear cells RNA isolation for whole-transcriptome shotgun sequencing.

  7. Changes in Epigenomics

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    Whole blood samples for Immune cell populations and peripheral blood mononuclear cells RNA isolation for whole-transcriptome shotgun sequencing.

  8. Changes in Proteomics

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    sera: MS and ELISA

  9. Changes in Metabolomics

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    sera: MS and ELISA

  10. Changes in relative species abundance of skin microbioma

    Time frame: Baseline, 2 years Follow Up (optional: after 1 year Follow Up)

    skin swab: DNA - sequencing

  11. Changes in BMI

    Time frame: Baseline, 2 years Follow Up (optional: after 1 year Follow Up)

    body mass index (kg/m²)

  12. Changes in circumference

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    circumference measurement (cm): waist and hip

  13. Gender identity

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    questionnaire: Transgender Congruence Scale (TCS) & gender dysphoria

  14. Changes in physical activity

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    questionnaire: International Physical Activity Questionnaire / IPAQ

  15. Changes in mental health

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    questionnaire: Generalized Anxiety Disorder / GAD-7

  16. Changes in Perceived Stress

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    questionnaire: Perceived Stress Questionnaire / PSQ

  17. Changes in quality of life

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    questionnaire: quality of life / PROMIS

  18. Changes in depression

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    questionnaire: Beck-Depressions-Inventar Revision / BDI II & The Patient Health Questionnaire (PHQ-9)

  19. Changes in chrono type / sleep-wake behaviour

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    questionnaire: Munich ChronoType Questionnaire (MCTQ)

  20. Changes in dietary habits

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    Food Frequency Quenstionnaire /FFQ, special diet and intake of dietary supplements, prebiotics and probiotics

  21. Changes in socio-demographics

    Time frame: Baseline, 12, 24, 48 and 60 months Follow Up

    Family status, education level, current working status, and living situation

  22. Documentation of HRT

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    HRT medication, dosing, regimes, and progress as well as all transition -relevant surgery and physical changes

  23. Changes in vital signs

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    Systolic and diastolic blood pressure and heart rate

  24. Changes in life style risk parameters

    Time frame: Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up

    Smoking status, alcohol consumption and use of recreational drugs

  25. Changes in CVD risk scores

    Time frame: Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)

    Framingham risk scores (FRS) and Systematic Coronary Risk Evaluation (SCORE)

  26. Changes in FVC (in liters)

    Time frame: Baseline, 2 years & 5 years Follow Up (optional: one year follow up)

    Lung function: spirometry

  27. Changes in FEV1 (in liters)

    Time frame: Baseline, 2- and 5 years follow-up (optional: one year follow up)

    lung function: spirometry

  28. Changes FEV1/FVC (in %)

    Time frame: Baseline, 2- and 5 years follow-up (optional: one year follow up)

    Lung function: spirometry

  29. Changes in fatmass (kg)

    Time frame: Baseline, 2 years and 5 years Follow up (optional: one year follow up)

    Body composition

  30. Changes in fatmass (%)

    Time frame: Baselie, 2- and 5 years follow-up (optional: one year follow up)

    Body composition

  31. Changes in fat-free mass (in kg)

    Time frame: Baseline, 2- and 5 years follow-up (optional: one year follow-up)

    Body composition

  32. Changes in fat-free mass (in %)

    Time frame: Baseline, 2- and 5 years follow-up (optional: one year follow-up)

    Body composition

  33. Changes in body cell mass (in kg)

    Time frame: Baseline, 2- and 5 years follow-up (optional: one year follow-up)

    Body composition

  34. Changes in total body water (in liters)

    Time frame: Baseline, 2- and 5 years follow-up (optional: one year follow-up)

    Body composition

Study contacts

Contact information is provided by the study sponsor or research team.

Lajos Marko, Dr.

CONTACT

[email protected]

Sofia Forslund, Prof. Dr.

CONTACT

[email protected]

+49 30 450540649

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

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

Acronym: XCVD

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 19, 2022
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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