Actively Recruiting

Age: 18Years - 50Years
All Genders
ID05334888

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

Led by Charite University, Berlin, Germany · Updated on 2024-02-09

200

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

D

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how sex hormones affect the gut microbiome and the development of cardiovascular risk factors in healthy transgender individuals. This observational study will follow 200 participants undergoing hormone replacement therapy (HRT) for two years, aiming to understand the relationship between hormone changes, the microbiome, immune system, and cardiovascular disease risk. The study uses advanced scientific methods like omics platforms and systems biology to collect comprehensive data. Participants will be monitored at baseline and at multiple follow-up points, including an optional one-year check, with analyses of gut bacteria, hormone levels, immune markers, and cardiovascular indicators. The study also tracks changes in physical activity, mental health, diet, and quality of life during the two-year period. Participants will undergo regular assessments including microbiome analysis, blood tests, mental health questionnaires, and physical measurements at baseline, 6, 12, 18, and 24 months. Researchers will document hormone therapy details, lifestyle factors, and cardiovascular risk scores over time. The study aims to provide detailed insights into how sex hormones and the gut microbiome interact to influence cardiovascular health in transgender individuals.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 50 years
  • Ability to speak German or English
  • Previous gender hormone replacement therapy (HRT)
  • Ability to give informed consent and provide written consent
  • Having health insurance for clarification of incidental findings
Not Eligible

You will not qualify if you...

  • Diseases or functional disorders that prevent participation as determined by the study physician
  • Inability to fully understand the nature, significance, and scope of the study due to incapacity or other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 2 years

Participants are observed over time to collect data on cardiovascular risk factors, hormone levels, gut microbiome, and lifestyle changes.

Visits at baseline, 6, 12, 18, and 24 months with optional 1 year follow-up assessments

Trial Site Locations

Total: 1 location

1

Experimental and Clinical Research Center, Clinical Research Unit

Berlin, Germany, 13125

Actively Recruiting

Loading map...

Research Team

S

Sofia Forslund, Prof. Dr.

L

Lajos Marko, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

A First in Human Phase 1 Trial of OX118 in Healthy Volunteer...

Immune System

Actively Recruiting

1 location

A Non-Interventional Pilot Study to Explore the Role of Gut ...

Gut Microbiome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Sex hormone-dependent host-microbiome interactions and cardiovascular risk (XCVD): design of a longitudinal multi-omics cohort study.

Kristina Franz, Lajos Markó, Anja Mähler...

https://pubmed.ncbi.nlm.nih.gov/39788783