Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/12/2016
Date assigned
24/03/2017
Last edited
10/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). T2DM is a multi-factorial disease, meaning that it is associated with the effects of multiple genes in combination with lifestyle and environmental factors. The aim of this study is to look at the prevalence (commoness) and risk factors of impaired glucose metabolism (sugar breakdown) and diabetes in the general population.

Who can participate?
Men and women, aged between 40 and 65 years, registered at the municipal population registry of Hoorn.

What does the study involve?
In the year 2006, participants are asked to join the cohort (collection of participants). In the past 10 years, they visit the study centre three times, whilst being actively followed up for vital status by linking with the municipality register and for occurrence of long-term diseases. When they visit the centre, participants have a number of blood and urine samples taken to assess their blood sugar control, are weighted and measured, and fill out several questionnaires.

What are the possible benefits and risks of participating?
There are no notable benefits of participating. There is a small risk of pain and bruising following blood tests.

Where is the study run from?
The Diabetes Care and research Center in Hoorn (Netherlands)

When is study starting and how long is it expected to run for?
January 2006 to January 2050

Who is funding the study?
VU University Medical Center (Netherlands)

Who is the main contact?
1. Dr Joline Beulens (scientific)
j.beulens@vumc.nl
2. Dr Femke Rutters (scientific)
f.rutters@vumc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joline Beulens

ORCID ID

Contact details

VU University Medical Center
De Boelelaan 1089a
Amsterdam
1081HV
Netherlands
+31 20 4445860
j.beulens@vumc.nl

Type

Scientific

Additional contact

Dr Femke Rutters

ORCID ID

Contact details

VU University Medical Center
De Boelelaan 1089a
Amsterdam
1081HV
Netherlands
+31 20 4445860
f.rutters@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

A population-based study on glucose tolerance: the New Hoorn Study

Acronym

Study hypothesis

The aim of this study is to investigate whether the increasing rates of longevity, physical inactivity and obesity affected the prevalence and risk factors of disturbances in glucose metabolism.

Ethics approval

Medical Ethics Committee of the VU University Medical Center Amsterdam, 11/05/2006, ref: 2006/93

Study design

Observational prospective cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Community

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Type 2 diabetes

Intervention

Participants are enrolled from the Hoorn study, a population-based survey carried out in the city of Hoorn between 2006-2007. The first visit takes place in 2006-2007. In a subgroup, around 250 participants a follow up visit takes place after three years. The third visit takes place 8 years after baseline in the entire cohort.

For each visit, participants are requested to refrain from eating and drinking (except water) from 8:00 P.M. the night before the visit and from drinking alcohol from 5:00 P.M. the day before the visit. They are instructed to follow their usual diet the day before each visit and to be consistent in their diet (both in content and in approximate timing of evening meals and snacks) and physical activities on the pre-visit days. In addition, participants are requested not to smoke on the morning of the visit and not to come by bicycle. Participants do not follow these instructions will be asked to reschedule the visit. Upon arrival at the Diabetes Research Center, written informed consent is obtained. During the visit, height and weight are measured without shoes and heavy clothes. Waist circumference, hip circumference and blood pressure is measured. Fasting whole blood glucose from a capillary vein in the finger was determined on the spot. In participants with a fasting whole blood glucose level <10 mmol/l, a standard 75-g OGTT is performed. Venous blood samples are drawn before and 120 min after glucose ingestion. Finally, participants fill out questionnaires on lifestyle, medication, disease and SES. During the visit three years after baseline, microvascular function will be determined using capillary videomicroscopy of the dorsal skin of the nail fold.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Disturbances in glucose metabolism is 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 are measured using CES-D questionnaire at baseline and 7 year follow up
2. Quality of life is measured using questionnaires at baseline and 7 year follow up
3. Cardiovascular complications of diabetes are measured by a check of the medical records of the participants every three years

Overall trial start date

01/12/2005

Overall trial end date

01/01/2050

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women
2. Aged 40-65 years
3. From the municipal registry in the city of Hoorn

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

2807

Participant exclusion criteria

No exclusion criteria

Recruitment start date

13/07/2006

Recruitment end date

01/11/2007

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

Sponsor details

De Boelelaan 1089a
Amsterdam
1081HV
Netherlands
+ 31 20 4445860
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

Novartis Pharma B.V

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

the European Union

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

the Innovative Medicine Initiative

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Joline Beulens (hoornstudy@vumc.nl)

Intention to publish date

01/01/2051

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/08/2017: Internal review.