Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi FinTerveys Study

NCT03650127 | Unknown

• 1 other identifier: 1474/6.00.00/2018
• Study Type: observational
• Target: 3,449
• Locations: 1 country
• Sites: 1

Brief Summary

P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). The hypothesis of the study is that 1) combining genetic and metabolic risk with traditional risk factors adds value to the personal risk assessment of these diseases, 2) such risk information can be provided to individuals using a web based user portal in an easily understandable and useful format, and 3) receiving genetic and metabolomic risk information has an effect on the health of the study participants. The study is a continuation of FinHealth 2017 -study, which involved more than 7,000 Finns from around the country. The participants of FinHealth were invited to participate in P5.fi -study. The new research utilises information, samples, and measurements obtained in the FinHealth Study. Prospective clinical significance of selected genetic and metabolomic risk scores will be studied in 30.000 Finnish individuals. The study will analyze the genetic and metabolomic profile of the P5.fi participants and develop and test a protocol for returning them health related risk information. The impact of the intervention will by followed up by questionnaires and national health registers for five years.

Conditions

Coronary Heart Disease; Type 2 Diabetes; Deep Vein Thrombosis

Keywords

Genetic risk score; metabolic risk score; health promotion; web-based; intervention

Outcome Measures

Primary Outcomes (1)

• Coronary heart disease/Type 2 diabetes/Venous thromboembolism diagnosis

  Disease diagnosis observed from the national hospitalization and death registries.

  Measure is assessed after a year from the start of the study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population of FinHealth 2017 -study represent the general population of Finland. All participants are over 18 years of age and have been selected randomly from the population registry. All FinHealth 2017 participants with DNA sample and permission for a re-contact were invited to P5.fi study.

You may qualify if:

• \- Only participants of FinHealth 2017 -study are eligible for the study

You may not qualify if:

• \- Participants not part of FinHealth 2017 -study are not eligible

Sponsors & Collaborators

• Markus Perola: lead
• University of Helsinki: collaborator
• Institute for Molecular Medicine: collaborator

Study Sites (1)

National Institute of Health and Welfare

Helsinki, Uusimaa, 00271, Finland

Location

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus, Type 2; Venous Thrombosis; Genetic Risk Score

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Thrombosis; Embolism and Thrombosis; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Perola, MD, PhD

  National Institute of Health and Welfare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: February 2, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

FI (1)