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 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H.J. de Koning
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| 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 | 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 outcome measures | 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 or 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 impaired fasting glucose (IFG) 7. Cost aspects |
| Overall study start date | 15/05/2006 |
| Completion date | 15/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Erasmus Medical Center
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Sponsor information
Erasmus Medical Center, Department of Public Health (The Netherlands)
University/education
University/education
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
