Population-based randomized controlled trial of screening for type 2 diabetes mellitus in high-risk subjects
Completed
- Conditions
- Diabetes Mellitus type 2 (DM type II)Nutritional, Metabolic, EndocrineDiabetes
- Registration Number
- ISRCTN75983009
- Lead Sponsor
- Erasmus Medical Center, Department of Public Health (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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 or 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 impaired fasting glucose (IFG)<br>7. Cost aspects