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Population based randomized controlled trial of screening for type 2 diabetes mellitus in high-risk subjects.


- candidate number2113
- NTR NumberNTR692
- ISRCTNISRCTN75983009
- Date ISRCTN created19-jul-2006
- date ISRCTN requested4-jul-2006
- Date Registered NTR31-mei-2006
- Secondary IDsN/A 
- Public TitlePopulation based randomized controlled trial of screening for type 2 diabetes mellitus in high-risk subjects.
- Scientific TitlePopulation based randomized controlled trial of screening for type 2 diabetes mellitus in high-risk subjects.
- ACRONYMN/A
- hypothesisSystematic 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus type 2 (DM type II)
- Inclusion criteria1. 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.
- Exclusion criteriaPre-existing type 1 or 2 diabetes.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 15-mei-2006
- planned closingdate15-mei-2016
- Target number of participants62000
- InterventionsSubjects will be randomized into a screening group and a control group. All subjects who have been allocated to the screening group will be invited for screening which comprises a fasting plasma glucose test (FPG). Additionally, serum triglycerides, total-cholesterol and HDL-cholesterol and 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 NHG-guidelines. Individuals with normal FPG (5.6 mmol/L or lower) will be invited for re-screening after 4 years. All subjects in both groups will receive written lifestyle intervention advice.
- Primary outcome1. 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 outcome1. 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/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 IFG; 7. Cost aspects.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. MD. H.J. Koning, de
- CONTACT for SCIENTIFIC QUERIESDr. MD. H.J. Koning, de
- Sponsor/Initiator Erasmus Medical Center, Department of Public Health, GGD (Municipal Health Service) Zuid Holland Zuid, GGD (Municipal Health Service) Rotterdam e.o.
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe aim of this study is to establish whether systematic screening for type 2 diabetes mellitus in high-risk obese subjects can significantly reduce the diabetes-related cardiovascular morbidity and mortality among diabetic patients by at least 25%, resulting in a 5% reduction of these endpoints within the entire overweight/obese population. The study will be a population-based RCT in a high-risk group and has a total duration of 10 years. In the first year, feasibility of the project will be assessed in 20% of the intended sample size. Inclusion criteria are age (40-74 years), self-reported waist circumference (>80cm for women and > 94cm for men), long-term follow-up feasible, i.e. no presence of other chronic diseases that makes 5-year survival unlikely and no previous diagnosis of type 1 or type 2 diabetes. After identification of the personal data from municipal registries, 450.000 people will receive an invitation letter, information brochure, questionnaire, tape-measure and consent form. We aim at including 62.000 men and women, to be equally randomized over two study arms. The screening arm will be invited for a fasting plasma glucose (FPG) measurement. Blood lipids and blood pressure in a subset of individuals will additionally be measured to evaluate the ‘overlap’ between these risk factors in the obese population. Participants with ‘diabetes’ or ‘impaired fasting glucose’ will be referred to their GP for further diagnostics and treatment. The control arm will not be invited for a FPG. Both groups will receive written information about beneficial effects of a healthy life style. The primary endpoint is based on the first occurrence, within the follow-up period after randomization, of a fatal or non-fatal cardiovascular event.
- Main changes (audit trail)
- RECORD31-mei-2006 - 23-aug-2006


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