FINRISK 2002 Re-examination

Cardiovascular Diseases Clinical Trial

Official title:

FINRISK 2002 Re-examination

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06284772
• Other study ID #: 4457/2023
• Status: Enrolling by invitation
• Start date: November 13, 2023
• Est. completion date: June 25, 2024

Study information

• Verified date: February 2024
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2300
• Est. completion date: June 25, 2024
• Est. primary completion date: June 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 47 Years to 96 Years

Eligibility

Inclusion Criteria:

• Participation in FINRISK 2002 fecal sampling

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Cardiovascular Diseases
• Metabolic Syndrome

Intervention

Other:
• Questionnaire and fecal sampling
The participants will be mailed a fecal collection kit and a 20-page health questionnaire. This questionnaire will include the similar questions concerning health, lifestyles, and diet as in 2002.
• Health examination
This examination will include measurements for anthropometrics, cognition (MoCA, Stroop, DSST), and blood pressure. The participants will undergo blood draw for laboratory analyses of CMD risk factors, such as blood lipids, glucose metabolism (fasting glucose, HbA1c, and fasting insulin), liver enzymes (GGT, ALT, and AST), inflammation (hs-CRP), and cardiac markers (proBNP and hs-TnI). We will perform ultrasound imaging for hepatic fibrosis.

Locations

Country	Name	City	State
Finland	University of Turku	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Finnish Institute for Health and Welfare

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Borodulin K, Tolonen H, Jousilahti P, Jula A, Juolevi A, Koskinen S, Kuulasmaa K, Laatikainen T, Mannisto S, Peltonen M, Perola M, Puska P, Salomaa V, Sundvall J, Virtanen SM, Vartiainen E. Cohort Profile: The National FINRISK Study. Int J Epidemiol. 2018 Jun 1;47(3):696-696i. doi: 10.1093/ije/dyx239. No abstract available. — View Citation

Salosensaari A, Laitinen V, Havulinna AS, Meric G, Cheng S, Perola M, Valsta L, Alfthan G, Inouye M, Watrous JD, Long T, Salido RA, Sanders K, Brennan C, Humphrey GC, Sanders JG, Jain M, Jousilahti P, Salomaa V, Knight R, Lahti L, Niiranen T. Taxonomic signatures of cause-specific mortality risk in human gut microbiome. Nat Commun. 2021 May 11;12(1):2671. doi: 10.1038/s41467-021-22962-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiome change between 2002-2024	Individual-level changes in the metagenome-sequenced gut microbiome between 2002 and 2024. The microbiome indices of interest are: Alpha diversity; Beta diversity; Taxonomy	2002-2024
Secondary	Correlates of gut microbiome change between 2002-2024	Questionnaire-, biochemistry-, and health examination-derived correlates of gut microbiome change between 2002-2024.	2002-2024