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
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
-
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.
-
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.