FINRISK 2002 Re-examination

NCT06284772 | Completed

• 1 other identifier: 4457/2023
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Syndrome; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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: 1. Alpha diversity 2. Beta diversity 3. Taxonomy

  2002-2024

Secondary Outcomes (1)

• Correlates of gut microbiome change between 2002-2024

  2002-2024

Study Arms (2)

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

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; Other: Health examination

Interventions

Questionnaire and fecal sampling OTHER

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 cohort; FINRISK 2002 re-examination health examination

Health examination OTHER

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.

FINRISK 2002 re-examination health examination

Eligibility Criteria

• Age: 47 Years - 96 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participation in FINRISK 2002 fecal sampling

Sponsors & Collaborators

• University of Turku: lead
• Finnish Institute for Health and Welfare: collaborator

Study Sites (1)

University of Turku

Turku, 20100, Finland

Location

Related 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.

  PMID: 29165699 BACKGROUND

• 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.

  PMID: 33976176 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples for 2500 individuals. Serum and plasma samples for 269 individuals who took part in the health examination.

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases

Interventions

Surveys and Questionnaires; Nutrition Surveys

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Epidemiologic Measurements

Study Officials

• Teemu Niiranen, MD

  Department of Internal Medicine, University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 29, 2024
• Study Start: November 13, 2023
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)