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OpenTrials
Completed

NCT Number: NCT06284772

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.

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Key information

Conditions

Cardiometabolic Syndrome Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

47 year–96 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Turku

Turku, 20100, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in FINRISK 2002 fecal sampling

Treatment and study plan

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.

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.

Primary outcomes

  1. Gut microbiome change between 2002-2024

    Time frame: 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

Secondary outcomes

  1. Correlates of gut microbiome change between 2002-2024

    Time frame: 2002-2024

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

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Finnish Institute for Health and Welfare

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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