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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05334888

Collaborator

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

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The XCVD pilot 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.

Condition or Disease	Intervention/Treatment	Phase
Transgender Gut Microbiome Immune System Cardiovascular Risk Factors

Detailed Description

Conducting this innovative pilot 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2026

Outcome Measures

Primary Outcome Measures

Changes in relative species abundance of intestinal bacteria compared [two visits: Baseline, 2 years Follow Up]
baseline and 2 years after initiation of hormone replacement therapy. stool samples: Analysis with 16s rRNA sequencing

Secondary Outcome Measures

Changes in cardio marker [two visits: Baseline, 2 years Follow Up]
sera: following cardio marker can be determined by Electro Chemiluminescence Immuno-Assay: BNP and hs-troponin.
Changes in hormone parameters [two visits: Baseline, 2 years 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 [two visits: Baseline, 2 years Follow Up]
sera: pro- and anti-inflammatory cytokines using cytokine - multiplex panel and Immune cell populations with shotgun sequencing
Changes in the concentration of cortisol [two visits: Baseline, 2 years Follow Up]
Hair sample: Hair steroid analysis with Immunoassay and LC-MS/MS
Changes in Transcriptomics [two visits: Baseline, 2 years Follow Up]
Capillary blood sample for Immune cell populations: RNA isolation for whole-transcriptome shotgun sequencing.
Changes in Proteomics [two visits: Baseline, 2 years Follow Up]
sera: MS and ELISA
Changes in Metabolomics [two visits: Baseline, 2 years Follow Up]
sera: MS and ELISA
Changes in relative species abundance of skin microbioma [two visits: Baseline, 2 years Follow Up]
skin swab: DNA - sequencing
Changes in BMI [two visits: Baseline, 2 years Follow Up]
body mass index (kg/m²)
Changes in circumference [two visits: Baseline, 2 years Follow Up]
circumference measurement (cm)
Changes in physical activity [two visits: Baseline, 2 years Follow Up]
questionnaire: International Physical Activity Questionnaire / IPAQ
Changes in mental health [two visits: Baseline, 2 years Follow Up]
questionnaire: Generalized Anxiety Disorder / GAD-7
Changes in Perceived Stress [two visits: Baseline, 2 years Follow Up]
questionnaire: Perceived Stress Questionnaire / PSQ
Changes in quality of life [two visits: Baseline, 2 years Follow Up]
questionnaire: quality of life / PROMIS
Changes in depression [two visits: Baseline, 2 years Follow Up]
questionnaire: Beck-Depressions-Inventar Revision / BDI II
Changes in dietary habits [two visits: Baseline, 2 years Follow Up]
Food Frequency Quenstionnaire /FFQ

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Charite University, Berlin, Germany
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Investigators

Study Director: Sofia Forslund, Dr., Max-Delbrück-Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Short proposal of the study

Publications

None provided.

Responsible Party:

Dr. Lajos Marko, Dr., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT05334888

Other Study ID Numbers:

ChariteU - ECRC XCVD

First Posted:

Apr 19, 2022

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Lajos Marko, Dr., Charite University, Berlin, Germany

Transgender Medicine

Study Results

No Results Posted as of Apr 19, 2022