FINRISK 2002 Re-examination

Completed

• Conditions: Cardiovascular Diseases; Cardiometabolic Syndrome
• Interventions: Other: Questionnaire and fecal sampling; Other: Health examination

• Registration Number: NCT06284772
• Lead Sponsor: University of Turku

Brief Summary

The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of \~2300 Finnish individuals who gave stool samples in the year 2002. In addition, \~300 individuals will undergo a in-depth health examination in 2024.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-13
• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-02-29
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Participation in FINRISK 2002 fecal sampling

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FINRISK 2002 re-examination health examination	Health examination	The \~800 still-living participants from the Turku and Loimaa area will be also asked to participate in a health examination.
FINRISK 2002 re-examination health examination	Questionnaire and fecal sampling	The \~800 still-living participants from the Turku and Loimaa area will be also asked to participate in a health examination.
FINRISK 2002 re-examination cohort	Questionnaire and fecal sampling	All still-living FINRISK 2002 participants (\~6000) will be invited do participate in a re-examination \>20 years after the initial fecal sampling.

Primary Outcome Measures

Name	Time	Method
Gut microbiome change between 2002-2024	2002-2024	Individual-level changes in the metagenome-sequenced gut microbiome between 2002 and 2024. The microbiome indices of interest are: 1. Alpha diversity; 2. Beta diversity; 3. Taxonomy

Secondary Outcome Measures

Name	Time	Method
Correlates of gut microbiome change between 2002-2024	2002-2024	Questionnaire-, biochemistry-, and health examination-derived correlates of gut microbiome change between 2002-2024.

Trial Locations

Locations (1)

University of Turku; 🇫🇮 Turku, Finland