Gene-lifestyle interactions and complex traits Involved in elevated disease risk

ISRCTN	ISRCTN35275922
DOI	https://doi.org/10.1186/ISRCTN35275922
Secondary identifying numbers	Dnr 2015-197-32M

Submission date: 05/10/2017
Registration date: 17/11/2017
Last edited: 17/11/2017

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Since 1986, all residents of the northern Swedish county of Västerbotten who turned 40, 50 and/or 60 years are invited to visit the primary care centre. The aim of this study is to use the extensive data collected as part of this ongoing health survey in order to address questions related to lifestyle and genetic risk factors in cardiometabolic disease (e.g., heart disease and type 2 diabetes).

Who can participate?
Adults aged 40, 50, and 60 from Västerbotten

What does the study involve?
Patients complete a detailed lifestyle questionnaire and provide blood samples. The blood sample is used to measure blood glucose (sugar), blood lipids (fat, cholesterol), and genetic information. The data is used to find out whether lifestyle/environmental factors affect the link between genetics and human character (e.g. body mass index, blood glucose).

What are the possible benefits and risks of participating?
Participants receive some health-related advice as part of the background study, which may be perceived as a benefit. Risks include those related to the handling of sensitive personal data. There are no significant treatment-related risks.

Where is the study run from?
Primary Care Center in Västerbotten (Sweden)

When is the study starting and how long is it expected to run for?
January 1986 to December 2025

Who is funding the study?
1. Swedish Research Council (Sweden)
2. Novo Nordisk (Denmark)
3. Swedish Heart-Lung Foundation (Sweden)
4. Swedish Diabetes Association (Sweden)

Who is the main contact?
Prof. Paul Franks

Contact information

Prof Paul Franks
Scientific

Department of Clinical Sciences, Genetic and Molecular Epidemiology
CRC, Building 91, Level 10
Jan Waldenströms gata 35
Skåne University Hospital Malmö
Malmö
21428
Sweden

Study information

Study design	Prospective population-based cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Gene-lifestyle interactions and complex traits involved in elevated disease risk: a prospective population-based cohort study
Study acronym	GLACIER
Study objectives	The GLACIER study was designed to estimate the separate and combined effects of genetic and lifestyle factors in cardiometabolic disease.
Ethics approval(s)	The Regional Ethics Review Board in Umeå, 21/10/2010, ref: Dnr 2015-197-32M
Health condition(s) or problem(s) studied	Cardiovascular disease and type 2 diabetes
Intervention	All participants are asked to complete a questionnaire concerning various lifestyle factors including diet and to donate a blood sample for for later research purposes. The blood samples were then measured for blood glucose, blood lipid profiles (e.g. triglyceride, HDL-cholesterol) and for genetic information. Body weight and height were measured. The study is focused on whether lifestyle/environmental factors influence the association between genetics and human character (e.g. body mass index, blood glucose).
Intervention type	Mixed
Primary outcome measure	Many hundreds of exposure and outcome variables including type 2 diabetes, myocardial infarction and stroke, derived from health survey data every 10 years
Secondary outcome measures	Secondary outcomes include quantitative cardiometabolic traits (e.g., blood pressure, glucose, and lipids, and anthropometry) usually assessed in the year of each participant’s 40, 50, 60th or 70th birthdays. Examinations occurred between 1986 and 2007
Overall study start date	01/01/1986
Completion date	31/12/2025

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	100000
Key inclusion criteria	All individuals 40, 50, and 60 years of age in the county’s population are invited
Key exclusion criteria	People who are not able to consent or not living in the county
Date of first enrolment	01/01/1986
Date of final enrolment	01/01/2020

Locations

Countries of recruitment

Sweden

Study participating centre

Primary Care Center in Västerbotten

SE-901 87

Sponsor information

Umeå University Department of Biobank Research
University/education

Department of Biobank Research
Umeå University
Umeå
SE-901 87
Sweden

Website	http://www.biobank.umu.se/biobank/
"ROR"	https://ror.org/05kb8h459

Funders

Funder type

Government

Vetenskapsrådet
Government organisation / National government

Alternative name(s): Swedish Research Council, VR
Location: Sweden

Novo Nordisk
Private sector organisation / For-profit companies (industry)

Alternative name(s): Novo Nordisk Global
Location: Denmark

Hjärt-Lungfonden
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Swedish Heart-Lung Foundation
Location: Sweden

Diabetesförbundet
Private sector organisation / Associations and societies (private and public)

Alternative name(s): Swedish Diabetes Foundation, Svenska Diabetesförbundet
Location: Sweden

Results and Publications

Intention to publish date	31/12/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Papers are published on an ongoing basis in peer reviewed biomedical journals.
IPD sharing plan	The datasets generated during and/or analysed during the current study is not expected to be made available due to consenting constraints.