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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in relative species abundance of intestinal bacteria compared | baseline and 2 years and 5 years after initiation of hormone replacement therapy. stool samples: Analysis with 16s rRNA sequencing | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cardio marker | sera: following cardio marker can be determined by Electro Chemiluminescence Immuno-Assay: BNP and hs-troponin. | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in hormone parameters |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy transgender individuals during their gender hormone replacement therapy (HRT)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Forslund, Prof. Dr. | Contact | +49 30 450540649 | sofia.forslund@mdc-berlin.de | |
| Lajos Marko, Dr. | Contact | lajos.marko@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Sofia Forslund, Dr. | Max-Delbrück-Center | Study Director |
| Lajos Marko | Charite - Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental and Clinical Research Center, Clinical Research Unit | Recruiting | Berlin | 13125 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35177860 | Result | 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. | |
| 35177859 |
| Label | URL |
|---|---|
| Short proposal of the study | View source |
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Sera Plasma Whole blood Feces Saliva Hair Skin
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.
| Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in immune marker | sera: pro- and anti-inflammatory cytokines using cytokine - multiplex panel and Immune cell populations with shotgun sequencing | 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 | Hair sample: Hair steroid analysis with Immunoassay and LC-MS/MS | Baseline, 2 years and 5 years Follow Up (optional: one year follow up) |
| Changes in the oral species abundance | saliva sample / oral / mouth: species abundance of oral bacteria (sequencing) | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in Immune cell marker / regulatory T-cells | Whole blood samples for Immune cell populations and peripheral blood mononuclear cells RNA isolation for whole-transcriptome shotgun sequencing. | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in Epigenomics | Whole blood samples for Immune cell populations and peripheral blood mononuclear cells RNA isolation for whole-transcriptome shotgun sequencing. | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in Proteomics | sera: MS and ELISA | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in Metabolomics | sera: MS and ELISA | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in relative species abundance of skin microbioma | skin swab: DNA - sequencing | Baseline, 2 years Follow Up (optional: after 1 year Follow Up) |
| Changes in BMI | body mass index (kg/m²) | Baseline, 2 years Follow Up (optional: after 1 year Follow Up) |
| Changes in circumference | circumference measurement (cm): waist and hip | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Gender identity | questionnaire: Transgender Congruence Scale (TCS) & gender dysphoria | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in physical activity | questionnaire: International Physical Activity Questionnaire / IPAQ | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in mental health | questionnaire: Generalized Anxiety Disorder / GAD-7 | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in Perceived Stress | questionnaire: Perceived Stress Questionnaire / PSQ | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in quality of life | questionnaire: quality of life / PROMIS | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in depression | questionnaire: Beck-Depressions-Inventar Revision / BDI II & The Patient Health Questionnaire (PHQ-9) | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in chrono type / sleep-wake behaviour | questionnaire: Munich ChronoType Questionnaire (MCTQ) | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in dietary habits | Food Frequency Quenstionnaire /FFQ, special diet and intake of dietary supplements, prebiotics and probiotics | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in socio-demographics | Family status, education level, current working status, and living situation | Baseline, 12, 24, 48 and 60 months Follow Up |
| Documentation of HRT | HRT medication, dosing, regimes, and progress as well as all transition -relevant surgery and physical changes | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in vital signs | Systolic and diastolic blood pressure and heart rate | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in life style risk parameters | Smoking status, alcohol consumption and use of recreational drugs | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up |
| Changes in CVD risk scores | Framingham risk scores (FRS) and Systematic Coronary Risk Evaluation (SCORE) | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) |
| Changes in FVC (in liters) | Lung function: spirometry | Baseline, 2 years & 5 years Follow Up (optional: one year follow up) |
| Changes in FEV1 (in liters) | lung function: spirometry | Baseline, 2- and 5 years follow-up (optional: one year follow up) |
| Changes FEV1/FVC (in %) | Lung function: spirometry | Baseline, 2- and 5 years follow-up (optional: one year follow up) |
| Changes in fatmass (kg) | Body composition | Baseline, 2 years and 5 years Follow up (optional: one year follow up) |
| Changes in fatmass (%) | Body composition | Baselie, 2- and 5 years follow-up (optional: one year follow up) |
| Changes in fat-free mass (in kg) | Body composition | Baseline, 2- and 5 years follow-up (optional: one year follow-up) |
| Changes in fat-free mass (in %) | Body composition | Baseline, 2- and 5 years follow-up (optional: one year follow-up) |
| Changes in body cell mass (in kg) | Body composition | Baseline, 2- and 5 years follow-up (optional: one year follow-up) |
| Changes in total body water (in liters) | Body composition | Baseline, 2- and 5 years follow-up (optional: one year follow-up) |
| Result |
| 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. Epub 2022 Feb 17. |
| 39788783 | Derived | 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. |