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

Type 2 Diabetes Clinical Trial

— P5  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03650127
• Other study ID #: 1474/6.00.00/2018
• Status: Active, not recruiting
• Start date: February 2, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Finnish Institute for Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3449
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Deep Vein Thrombosis
• Heart Diseases
• Myocardial Ischemia
• Thrombosis
• Type 2 Diabetes
• Venous Thrombosis

Locations

Country	Name	City	State
Finland	National Institute of Health and Welfare	Helsinki	Uusimaa

Sponsors (3)

Lead Sponsor	Collaborator
Markus Perola	Institute for Molecular Medicine, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.