Population based randomized controlled trial of screening for type 2 diabetes mellitus in high-risk subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NL-OMON23901
- Lead Sponsor
- Primary Sponsor: Erasmus MC, Department of Public Health. Secondary Sponsors: GGD (Municipal Health Service) Zuid Holland Zuid and GGD Rotterdam en omsreken.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 62000
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.
Exclusion Criteria
Pre-existing type 1 or 2 diabetes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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); <br>2. All cause mortality.
- Secondary Outcome Measures
Name Time Method 1. Prevalence of unknown type 2 diabetes detected by screening; <br>2. Screening performance: attendance, referral and detection rates, and test characteristics; <br>3. Contamination rates; <br>4. Change over time in the level of blood parameters: glucose, lipids, glycated haemoglobin and blood pressure in diabetic subjects; <br>5. Change/improvement in the cardiovascular risk profile after screen-detected diabetes and comparisons with control arm; <br>6. Modifications in lifestyle (diet, physical activity level, smoking) in both type 2 diabetes cases and those with IFG; <br>7. Cost aspects.