FINRISK 2002 Re-examination

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cardiometabolic Syndrome
• Intervention / Treatment: Other: Questionnaire and fecal sampling; Other: Health examination

• Study Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20100
    • University of Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The FINRISK 2002 cohort (N=7,237 participants with sequenced fecal samples) was originally examined in 2002. The FINRISK 2002 cohort is a random sample of the Finnish population, aged 25-74 years in the year 2002, from 6 geographic regions in Finland.

Description

Inclusion Criteria:

• Participation in FINRISK 2002 fecal sampling

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FINRISK 2002 re-examination cohort; All still-living FINRISK 2002 participants (~6000) were invited do participate in a re-examination >20 years after the initial fecal sampling. 2500 took part in the study.	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.
FINRISK 2002 re-examination health examination; The ~800 still-living participants from the Turku and Loimaa area were asked to participate in a health examination. 269 individuals took part in the health examination.	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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlates of gut microbiome change between 2002-2024	Questionnaire-, biochemistry-, and health examination-derived correlates of gut microbiome change between 2002-2024.	2002-2024

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: Finnish Institute for Health and Welfare
• Investigators: Principal Investigator: Teemu Niiranen, MD, Department of Internal Medicine, University of Turku

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: 4457/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No