Cardiovascular Risk Factors, Gut Microbiome, Immune System, Transgender
Conditions
Keywords
Transgender Medicine
Brief summary
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in relative species abundance of intestinal bacteria compared | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in cardio marker | 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. |
| Changes in hormone parameters | 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. |
| Changes in immune marker | 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 |
| Changes in the concentration of of cortisol, progesterone, testosterone and dehydroepiandrosterone | Baseline, 2 years and 5 years Follow Up (optional: one year follow up) | Hair sample: Hair steroid analysis with Immunoassay and LC-MS/MS |
| Changes in the oral species abundance | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) | saliva sample / oral / mouth: species abundance of oral bacteria (sequencing) |
| Changes in Immune cell marker / regulatory T-cells | 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. |
| Changes in Epigenomics | 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. |
| Changes in Proteomics | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) | sera: MS and ELISA |
| Changes in Metabolomics | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) | sera: MS and ELISA |
| Changes in relative species abundance of skin microbioma | Baseline, 2 years Follow Up (optional: after 1 year Follow Up) | skin swab: DNA - sequencing |
| Changes in BMI | Baseline, 2 years Follow Up (optional: after 1 year Follow Up) | body mass index (kg/m²) |
| Changes in circumference | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) | circumference measurement (cm): waist and hip |
| Gender identity | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up | questionnaire: Transgender Congruence Scale (TCS) \& gender dysphoria |
| Changes in physical activity | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up | questionnaire: International Physical Activity Questionnaire / IPAQ |
| Changes in mental health | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up | questionnaire: Generalized Anxiety Disorder / GAD-7 |
| Changes in Perceived Stress | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up | questionnaire: Perceived Stress Questionnaire / PSQ |
| Changes in quality of life | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up | questionnaire: quality of life / PROMIS |
| Changes in depression | 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) |
| Changes in chrono type / sleep-wake behaviour | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up | questionnaire: Munich ChronoType Questionnaire (MCTQ) |
| Changes in dietary habits | 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 |
| Changes in socio-demographics | Baseline, 12, 24, 48 and 60 months Follow Up | Family status, education level, current working status, and living situation |
| Documentation of HRT | 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 |
| Changes in vital signs | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) | Systolic and diastolic blood pressure and heart rate |
| Changes in life style risk parameters | Baseline, 6, 12, 18, 24, 36, 48 and 60 months Follow Up | Smoking status, alcohol consumption and use of recreational drugs |
| Changes in CVD risk scores | Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up) | Framingham risk scores (FRS) and Systematic Coronary Risk Evaluation (SCORE) |
| Changes in FVC (in liters) | Baseline, 2 years & 5 years Follow Up (optional: one year follow up) | Lung function: spirometry |
| Changes in FEV1 (in liters) | Baseline, 2- and 5 years follow-up (optional: one year follow up) | lung function: spirometry |
| Changes FEV1/FVC (in %) | Baseline, 2- and 5 years follow-up (optional: one year follow up) | Lung function: spirometry |
| Changes in fatmass (kg) | Baseline, 2 years and 5 years Follow up (optional: one year follow up) | Body composition |
| Changes in fatmass (%) | Baselie, 2- and 5 years follow-up (optional: one year follow up) | Body composition |
| Changes in fat-free mass (in kg) | Baseline, 2- and 5 years follow-up (optional: one year follow-up) | Body composition |
| Changes in fat-free mass (in %) | Baseline, 2- and 5 years follow-up (optional: one year follow-up) | Body composition |
| Changes in body cell mass (in kg) | Baseline, 2- and 5 years follow-up (optional: one year follow-up) | Body composition |
| Changes in total body water (in liters) | Baseline, 2- and 5 years follow-up (optional: one year follow-up) | Body composition |
Countries
Germany
Contacts
CONTACTSofia Forslund, Prof. Dr.
CONTACTLajos Marko, Dr.
STUDY_DIRECTORSofia Forslund, Dr.
Max-Delbrück-Center
PRINCIPAL_INVESTIGATORLajos Marko
Charite - Universitätsmedizin Berlin
Outcome results
None listed