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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23901
Enrollment
62000
Registered
2006-05-31
Start date
2006-05-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Subjects 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 gluco

Sponsors

Primary Sponsor: Erasmus MC, Department of Public Health. Secondary Sponsors: GGD (Municipal Health Service) Zuid Holland Zuid and GGD Rotterdam en omsreken.
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Pre-existing type 1 or 2 diabetes.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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/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.

Contacts

Public ContactH.J. Koning, de

Erasmus Medical Center, Department of Public Health, P.O. Box 1738

h.dekoning@erasmusmc.nl+31 (0)10 4087723

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)