Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorCharite University, Berlin, Germany
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-50
Language requirements: German, English
Previous gender hormone replacement therapy (HRT).
Ability to give consent and written consent to participate.
Disqualifiers
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.
Trial population
Healthy transgender individuals during their gender hormone replacement therapy (HRT)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)Secondary outcomes
1
Changes in cardio marker
sera: following cardio marker can be determined by Electro Chemiluminescence Immuno-Assay: BNP and hs-troponin.
Time frame
Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)2
Changes in hormone parameters
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.
Time frame
Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)3
Changes in immune marker
sera: pro- and anti-inflammatory cytokines using cytokine - multiplex panel and Immune cell populations with shotgun sequencing
Time frame
Baseline, 2 years and 5 years Follow Up (optional: after 1 year Follow Up)4
Changes in the concentration of of cortisol, progesterone, testosterone and dehydroepiandrosterone
Hair sample: Hair steroid analysis with Immunoassay and LC-MS/MS
Time frame
Baseline, 2 years and 5 years Follow Up (optional: one year follow up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Charite University, Berlin, Germany
Lead sponsor
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Collaborator
Source ClinicalTrials.gov