Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/12/2016
Date assigned
03/04/2017
Last edited
12/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joline Beulens

ORCID ID

Contact details

De Boelelaan 1089a
Amsterdam
1081 HV
Netherlands
+31 (0)20 4440367
j.beulens@vumc.nl

Type

Scientific

Additional contact

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 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

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

Trial setting

Community

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/1989

Overall trial end date

01/01/2080

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women
2. Aged 50–75 years
3. Randomly selected from the municipal registry

Participant type

All

Age group

Senior

Gender

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

Trial 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

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, NWO

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

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

corporate

Location

Germany

Funder name

Diabetes Fonds

Alternative name(s)

Dutch Diabetes Research Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

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)

Intention to publish date

01/01/2081

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2017: Internal edit.