Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach
- Conditions
- Immune SystemTransgenderCardiovascular Risk FactorsGut Microbiome
- Registration Number
- NCT05334888
- Lead Sponsor
- Charite University, Berlin, Germany
- 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 two 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in relative species abundance of intestinal bacteria compared Baseline, 2 years Follow Up (optional: after 1 year Follow Up) baseline and 2 years after initiation of hormone replacement therapy. stool samples: Analysis with 16s rRNA sequencing
- Secondary Outcome Measures
Name Time Method Changes in the oral species abundance Baseline, 2 years Follow Up (optional: after 1 year Follow Up) saliva sample / oral / mouth: species abundance of oral bacteria (sequencing)
Changes in BMI Baseline, 2 years Follow Up (optional: after 1 year Follow Up) body mass index (kg/m²)
Changes in physical activity Baseline, 6, 12, 18 and 24 months Follow Up questionnaire: International Physical Activity Questionnaire / IPAQ
Changes in quality of life Baseline, 6, 12, 18 and 24 months Follow Up questionnaire: quality of life / PROMIS
Changes in depression Baseline, 6, 12, 18 and 24 months Follow Up questionnaire: Beck-Depressions-Inventar Revision / BDI II \& The Patient Health Questionnaire (PHQ-9)
Changes in cardio marker Baseline, 2 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 Immune cell marker / regulatory T-cells Baseline, 2 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 mental health Baseline, 6, 12, 18 and 24 months Follow Up questionnaire: Generalized Anxiety Disorder / GAD-7
Changes in chrono type / sleep-wake behaviour Baseline, 6, 12, 18 and 24 months Follow Up questionnaire: Munich ChronoType Questionnaire (MCTQ)
Changes in hormone parameters Baseline, 2 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 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 Perceived Stress Baseline, 6, 12, 18 and 24 months Follow Up questionnaire: Perceived Stress Questionnaire / PSQ
Changes in socio-demographics Baseline, 2 years Follow Up Family status, education level, current working status, and living situation
Changes in the concentration of of cortisol, progesterone, testosterone and dehydroepiandrosterone Baseline, 2 years Follow Up Hair sample: Hair steroid analysis with Immunoassay and LC-MS/MS
Changes in Proteomics Baseline, 2 years Follow Up (optional: after 1 year Follow Up) sera: MS and ELISA
Changes in dietary habits Baseline, 6, 12, 18 and 24 months Follow Up Food Frequency Quenstionnaire /FFQ, special diet and intake of dietary supplements, prebiotics and probiotics
Changes in CVD risk scores Baseline, 2 years Follow Up (optional: after 1 year Follow Up) Framingham risk scores (FRS) and Systematic Coronary Risk Evaluation (SCORE)
Changes in Epigenomics Baseline, 2 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 Metabolomics Baseline, 2 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 circumference Baseline, 2 years Follow Up (optional: after 1 year Follow Up) circumference measurement (cm): waist and hip
Gender identity Baseline, 6, 12, 18 and 24 months Follow Up questionnaire: Transgender Congruence Scale (TCS) \& gender dysphoria
Changes in vital signs Baseline, 2 years Follow Up (optional: after 1 year Follow Up) Systolic and diastolic blood pressure and heart rate
Changes in life style risk parameters Baseline, 2 years Follow Up Smoking status, alcohol consumption and use of recreational drugs
Documentation of HRT Baseline - HRT start, 6, 12, 18 and 24 months Follow Up HRT medication, dosing, regimes, and progress as well as all transition -relevant surgery and physical changes
Trial Locations
- Locations (1)
Experimental and Clinical Research Center, Clinical Research Unit
🇩🇪Berlin, Germany