Plain English Summary
Background and study aims
Type 2 diabetes is a chronic (long-term) disorder where blood glucose (sugar) levels are too high. The prevalence of type 2 diabetes is increasing worldwide, bringing a high risk of complications of the eyes, kidneys and foot, and cardiovascular (heart) diseases. Many risk factors for diabetes have been identified. However, many factors are involved in type 2 diabetes and questions remain on interactions between risk factors. The aim of this study is to assess the prevalence and risk factors of impaired glucose metabolism (a pre-diabetic state) and diabetes in the general population.
Who can participate?
Men and women aged 50–75 randomly selected from the municipal registry in the year 1989
What does the study involve?
The participants visit the centre six times over 25 years to provide blood and urine samples, to be tested for diabetes, to be measured, and to complete questionnaires. Participants are followed up using the municipality register to check for the occurrence of chronic diseases.
What are the possible benefits and risks of participating?
There is minimal risk of participating, except for some bruising from blood drawn.
Where is the study run from?
Diabetes Zorgsysteem locatie Hoorn (Netherlands)
When is the study starting and how long is it expected to run for?
January 1989 to January 2080
Who is funding the study?
1. VU University Medical Center of Amsterdam
2. Nederlandse Organisatie voor Wetenschappelijk Onderzoek
3. ZonMw
4. European Union
5. Novartis Pharma
6. Diabetes Fonds
7. Netherlands Heart Foundation
Who is the main contact?
1. Dr Joline Beulens
j.beulens@vumc.nl
2. Dr Femke Rutters
f.rutters@vumc.nl
Study website
Contact information
Type
Scientific
Contact name
Dr Joline Beulens
ORCID ID
Contact details
De Boelelaan 1089a
Amsterdam
1081 HV
Netherlands
+31 (0)20 4440367
j.beulens@vumc.nl
Type
Scientific
Contact name
Dr Femke Rutters
ORCID ID
Contact details
De Boelelaan 1089a
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 5860
f.rutters@vumc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Prospective observational study on the prevalence and determinants of glucose intolerance in a Dutch caucasian population: the Hoorn Study
Acronym
Study hypothesis
The Hoorn study was initiated to study the prevalence and risk factors of impaired glucose metabolism and diabetes in an elderly Caucasian population. This initially cross-sectional study has been extended to a prospective cohort over the past decades, to study the risk factors for disturbances in glucose metabolism and complications associated with disturbances in glucose metabolism.
Ethics approval(s)
Ethics Review Committee of the VU University Medical Center Amsterdam, 27/06/1989, ref: 89/092
Study design
Prospective observational study with five follow-up visits during a 25-year period, and ongoing registry of morbidity and mortality
Primary study design
Observational
Secondary study design
Longitudinal study
Study setting(s)
Community
Study type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Impaired glucose metabolism and type 2 diabetes
Intervention
Between the years 1989 and 1992, a population-based survey of glucose tolerance was performed in the Dutch city of Hoorn in the West-Friesland region of the Netherlands. During this baseline measurement, information was obtained on, among others, glucose metabolism, diabetes-related risk factor levels and complaints, lifestyle, dietary intake, and demographic variables.
Physical re-examinations, repeating the measurements at baseline with additional extensive measurement to assess diabetes complications, were conducted in 1990-1991, 1996-1998, 2000-2001, 2005-2007, and 2007-2009.
All visits have corresponding measurements, including glucose metabolism determined by fasting plasma glucose, 75-g Oral Glucose Tolerance Test and HbA1c; anthropometrics; blood plasma lipid levels; albumin/creatinine ratio; blood pressure; family history of diabetes, self-reported medication use, disease history, diabetes-related complaints, lifestyle determinants and socio-economic status.
Finally, in addition to physical follow-up visits, all participants are still actively followed up for vital status by linkage with the municipality register and for occurrence of cardiovascular disease, cancer and cause-specific mortality, by checking their medical records.
In subsamples of the cohort, extensive physical diabetes complications have been measured, such as a retinopathy screening, autonomic function tests, peripheral neuropathy, ankle-arm pressure-ratio, echo-doppler scanning van de carotis and electrocardiography. In all visits additional measurements have been conducted, which vary from visit to visit.
Intervention type
Other
Primary outcome measure
Disturbances in glucose metabolism, measured by fasting plasma glucose, 75-g Oral Glucose Tolerance Test and HbA1c at baseline and at the two follow-up measurements in 2010-2011 and 2013-2015
Secondary outcome measures
1. Depressive symptoms, measured using CES-D questionnaire at baseline and 7 year follow up
2. Quality of life, measured using questionnaires at baseline and 7 year follow up
3. Cardiovascular complications of diabetes, measured by a check of the medical records of the participants every 3 years
Overall study start date
01/01/1989
Overall study end date
01/01/2080
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women
2. Aged 50–75 years
3. Randomly selected from the municipal registry
Participant type(s)
All
Age group
Senior
Sex
Both
Target number of participants
2484
Participant exclusion criteria
Participants with a non-Caucasian background
Recruitment start date
01/01/1989
Recruitment end date
12/12/1992
Locations
Countries of recruitment
Netherlands
Study participating centre
Diabetes Zorgsysteem locatie Hoorn
Maelsonstraat 7
Hoorn
1624 NP
Netherlands
Sponsor information
Organisation
VU University Medical Center of Amsterdam
Sponsor details
De Boelelaan 1089a
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 5860
j.beulens@vumc.nl
Sponsor type
University/education
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
VU University Medical Center of Amsterdam
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nederlandse Organisatie voor Wetenschappelijk Onderzoek
Alternative name(s)
Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek), NWO:Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO), Dutch Research Council, Dutch Research Council, Netherlands, NWO
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Netherlands
Funder name
ZonMw
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Netherlands
Funder name
European Union
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novartis Pharma
Alternative name(s)
Novartis Deutschland GmbH, Novartis Pharma GmbH, Novartis Deutschland
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Germany
Funder name
Diabetes Fonds
Alternative name(s)
Dutch Diabetes Research Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Netherlands
Funder name
Netherlands Heart Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publications in high-impact peer reviewed journals
Intention to publish date
01/01/2081
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Joline Beulens (J.beulens@vumc.nl)
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|