Investigating how sex hormones affect gut microbiome and heart health in transgender individuals
Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.
This study tests how sex hormones affect gut health and heart risks in transgender individuals receiving hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05334888 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of sex hormones on the gut microbiome and the potential development of cardiovascular risk factors in transgender individuals undergoing hormone replacement therapy. Over two years, 200 healthy participants will be monitored for changes in their microbiome, metabolome, and immune system, while also assessing cardiovascular disease phenotypes. Utilizing advanced scientific methods, the study aims to quantify the influence of sex hormones on cardiovascular risk markers for the first time.
Who should consider this trial
Good fit: Ideal candidates are healthy transgender individuals aged 18-50 who are undergoing hormone replacement therapy.
Not a fit: Patients with significant health issues or those unable to understand the study's nature may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in transgender individuals.
How similar studies have performed: While the approach is innovative, similar studies have not been extensively documented, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Berlin
- Experimental and Clinical Research Center, Clinical Research Unit — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Lajos Marko — Charite - Universitätsmedizin Berlin
- Study coordinator: Sofia Forslund, Prof. Dr.
- Email: sofia.forslund@mdc-berlin.de
- Phone: +49 30 450540649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.