Study on the prevalence and determinants of glucose intolerance in a Dutch caucasian population: the Hoorn Study
| ISRCTN | ISRCTN33032170 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33032170 |
- Submission date
- 16/12/2016
- Registration date
- 03/04/2017
- Last edited
- 20/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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. Prof Dr Joline Beulens
J.beulens@amsterdamumc.nl
2. Dr Femke Rutters
f.rutters@amsterdamumc.nl
Contact information
Scientific
De Boelelaan 1089a
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 4440367 |
|---|---|
| J.beulens@amsterdamumc.nl |
Scientific
De Boelelaan 1089a
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 5860 |
|---|---|
| f.rutters@amsterdamumc.nl |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prospective observational study on the prevalence and determinants of glucose intolerance in a Dutch caucasian population: the Hoorn Study |
| Study acronym | Hoorn study |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/01/2080 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 2484 |
| Key inclusion criteria | 1. Men and women 2. Aged 50–75 years 3. Randomly selected from the municipal registry |
| Key exclusion criteria | Participants with a non-Caucasian background |
| Date of first enrolment | 01/01/1989 |
| Date of final enrolment | 12/12/1992 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hoorn
1624 NP
Netherlands
Sponsor information
University/education
De Boelelaan 1089a
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 5860 |
|---|---|
| J.beulens@amsterdamumc.nl | |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- Amsterdam UMC, Amsterdam University Medical Centres, AUMC
- Location
- Netherlands
Government organisation / National government
- 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
- Location
- Netherlands
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novartis Deutschland GmbH, Novartis Pharma GmbH, Novartis Deutschland
- Location
- Germany
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Diabetes Research Foundation
- Location
- Netherlands
No information available
Results and Publications
| Intention to publish date | 01/01/2081 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publications in high-impact peer reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Joline Beulens (J.beulens@amsterdamumc.nl) |
Editorial Notes
20/06/2025: Acronym added and study contacts updated.
12/07/2017: Internal edit.
