Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
27/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H.J. de Koning

ORCID ID

Contact details

Erasmus Medical Center
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087723
h.dekoning@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Systematic screening for type 2 diabetes in high-risk obese subjects, identified from the general population, can significantly reduce the diabetes-related cardiovascular morbidity and mortality by at least 25% compared with not offering a screening program.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Diabetes Mellitus type 2 (DM type II)

Intervention

Subjects will be randomized into a screening group or a control group. All subjects who have been allocated to the screening group will be invited for screening which comprises a fasting plasma glucose (FPG) test. Additionally, serum triglycerides, total-cholesterol, high-density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol will be measured. LDL-cholesterol will be calculated using the Friedewald equation. Those subjects with diabetes (FPG of 7.0 mmol/l or higher) or impaired fasting glucose (FPG between 5.7-6.9 mol/l) will be referred to the general practitioner for further diagnostic testing and/or treatment for type 2 diabetes according to Dutch College of General Practitioners (NHG) guidelines. Individuals with normal FPG (5.6 mmol/l or lower) will be invited for re-screening after four years. All subjects in both groups will receive written lifestyle intervention advice.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Cardiovascular morbidity and mortality based on the first occurrence of a non-fatal cardiovascular event (coronary heart disease, cerebrovascular accident, and death from any other disease of the circulatory system)
2. All cause mortality

Secondary outcome measures

1. Prevalence of unknown type 2 diabetes detected by screening
2. Screening performance: attendance, referral and detection rates, and test characteristics
3. Contamination rates
4. Change over time in the level of blood parameters: glucose, lipids, glycated haemoglobin and blood pressure in diabetic subjects
5. Change or improvement in the cardiovascular risk profile after screen-detected diabetes and comparisons with control arm
6. Modifications in lifestyle (diet, physical activity level, smoking) in both type 2 diabetes cases and those with impaired fasting glucose (IFG)
7. Cost aspects

Overall trial start date

15/05/2006

Overall trial end date

15/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age (40 to 74 years inclusive)
2. Waist circumference
3. Accounting for ethnicity
4. Women: 80 cm or higher; men: 94 cm or higher
5. Long-term follow-up feasible
6. No presence of other chronic diseases that makes 5-year survival unlikely

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

62000

Participant exclusion criteria

Pre-existing type 1 or 2 diabetes

Recruitment start date

15/05/2006

Recruitment end date

15/05/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Center, Department of Public Health (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (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

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22900932
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23818042

Publication citations

  1. Results

    Klijs B, Otto SJ, Heine RJ, van der Graaf Y, Lous JJ, de Koning HJ, Screening for type 2 diabetes in a high-risk population: study design and feasibility of a population-based randomized controlled trial., BMC Public Health, 2012, 12, 671, doi: 10.1186/1471-2458-12-671.

  2. Results

    Willems JI, Otto SJ, Klijs B, de Koning HJ, Screening for type 2 diabetes in a high-risk population: effects of a negative screening test after 4 years follow-up., Ann Behav Med, 2014, 47, 1, 102-110, doi: 10.1007/s12160-013-9525-3.

Additional files

Editorial Notes