Population-based randomized controlled trial of screening for type 2 diabetes mellitus in high-risk subjects
| ISRCTN | ISRCTN75983009 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75983009 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center, Department of Public Health (The Netherlands) |
| Funder | Netherlands Organisation for Health Research and Development (ZonMw) |
- Submission date
- 19/07/2006
- Registration date
- 19/07/2006
- Last edited
- 27/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Erasmus Medical Center
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 4087723 |
|---|---|
| h.dekoning@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
1. Prevalence of unknown type 2 diabetes detected by screening |
| Completion date | 15/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 62000 |
| Key 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 |
| Key exclusion criteria | Pre-existing type 1 or 2 diabetes |
| Date of first enrolment | 15/05/2006 |
| Date of final enrolment | 15/05/2016 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3000 DR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/08/2012 | Yes | No | |
| Results article | results | 01/02/2014 | Yes | No |
