Microbiome and metabolome features of the cardiometabolic disease spectrum.
Sebastien Fromentin, Sofia K Forslund, Kanta Chechi...
https://pubmed.ncbi.nlm.nih.gov/35177860Actively Recruiting
Led by Charite University, Berlin, Germany · Updated on 2024-02-09
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
C
Charite University, Berlin, Germany
Lead Sponsor
D
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Collaborating Sponsor
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
Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Total: 1 location
1
Experimental and Clinical Research Center, Clinical Research Unit
Berlin, Germany, 13125
Actively Recruiting
S
Sofia Forslund, Prof. Dr.
L
Lajos Marko, Dr.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Have more questions? Get in touch with our team for quick support
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
Sebastien Fromentin, Sofia K Forslund, Kanta Chechi...
https://pubmed.ncbi.nlm.nih.gov/35177860Yeela Talmor-Barkan, Noam Bar, Aviv A Shaul...
https://pubmed.ncbi.nlm.nih.gov/35177859Kristina Franz, Lajos Markó, Anja Mähler...
https://pubmed.ncbi.nlm.nih.gov/39788783