Condition category
Circulatory System
Date applied
05/10/2017
Date assigned
17/11/2017
Last edited
17/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Franks

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Dnr 2015-197-32M

Study information

Scientific title

Gene-lifestyle interactions and complex traits involved in elevated disease risk: a prospective population-based cohort study

Acronym

GLACIER

Study hypothesis

The GLACIER study was designed to estimate the separate and combined effects of genetic and lifestyle factors in cardiometabolic disease.

Ethics approval

The Regional Ethics Review Board in Umeå, 21/10/2010, ref: Dnr 2015-197-32M

Study design

Prospective population-based cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/01/1986

Overall trial end date

31/12/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All individuals 40, 50, and 60 years of age in the county’s population are invited

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

100000

Participant exclusion criteria

People who are not able to consent or not living in the county

Recruitment start date

01/01/1986

Recruitment end date

01/01/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Primary Care Center in Västerbotten
SE-901 87

Sponsor information

Organisation

Umeå University Department of Biobank Research

Sponsor details

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

Sponsor type

University/education

Website

http://www.biobank.umu.se/biobank/

Funders

Funder type

Government

Funder name

Vetenskapsrådet

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Sweden

Funder name

Novo Nordisk

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Denmark

Funder name

Hjärt-Lungfonden

Alternative name(s)

Swedish Heart-Lung Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

Diabetesförbundet

Alternative name(s)

Svenska Diabetesförbundet

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Sweden

Results and Publications

Publication and dissemination plan

Papers are published on an ongoing basis in peer reviewed biomedical journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study is not expected to be made available due to consenting constraints.

Intention to publish date

31/12/2026

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes