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11 February 2012
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| [ Print-friendly version ] |
| The European Diabetes Prevention Study |
| ISRCTN | ISRCTN15670600 |
| ClinicalTrials.gov identifier | |
| Public title | The European Diabetes Prevention Study |
| Scientific title | Reducing the burden of non-insulin dependent diabetes mellitus: a randomised controlled trial of behavioural interventions to modify diet and physical activity in people with impaired glucose tolerance Also from June 2011: A follow-up at 10 years of participants in the Newcastle Arm of the European Diabetes Prevention Study who remain free of type 2 diabetes at 10 years from baseline, based of diagnoses from within the trial or subsequent General Practitioner diagnoses: to assess the difference in incidence of type 2 diabetes between the intervention and control arms of the original study |
| Acronym | EDIPS-Newcastle. Also from June 2011: EDIPS2-Newcastle |
| Serial number at source | 057146, N0565163209 |
| Study hypothesis |
Reducing the burden of type two diabetes. To assess the effectiveness of a diet and exercise intervention programme to prevent or delay the onset of type two diabetes in people with Impaired Glucose Tolerance (IGT).
The null hypothesis is that there will be no difference in the proportions of intervention or control group subjects progressing to develop diabetes within five years. Please note that due to continuing follow-up the end date of this trial has been extended to 31/07/2007. The previous anticipated end date of this trial was 31/12/2006. Please note that as of 26/01/2009 this record was updated; due to further continuing follow-up the end date of this trial was extended to 31/12/2007. The initial anticipated end date of this trial was 31/12/2006. Please not that from June 2011 the original EDIPS-Newcastle participants, who remained free from type 2 diabetes,have been invited to return for a follow-up assessment at ten years from their original recruitment date. Participants for EDIPS-Newcastle were recruited from the UK. EDIPS-Newcastle is part of a European collaboration, participants in Finland have been recruited to the Finnish Diabetes Prevention study and participants in The Netherlands have been recruited to the SLIM study. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Newcastle and North Tyneside NHS Joint Ethics Committee (Local Research Ethics Committee 1) on 17/08/1999 (ref: 99/186)
Ethics approval for the follow-up study (EDIPS2) NRES Committee North East – Newcastle and North Tyneside on 16/03/2011 (ref: 11/NE/0036) |
| Study design | Multicentre, parallel design, randomised controlled study. Also from June 2011 a follow-up study at ten years. |
| Countries of recruitment | United Kingdom, Europe |
| Disease/condition/study domain | Diabetes |
| Participants - inclusion criteria |
1. Have IGT, defined as a mean two-hour plasma glucose value more than 7.8 and less than 11.1 mmol/l from two Oral Glucose Tolerance Tests (OGTTs), the second conducted one to 12 weeks after the first
2. Be aged 40 to 74 years on their last birthday, either sex 3. Be overweight (Body Mass Index [BMI] more than 25 kg/m^2) |
| Participants - exclusion criteria |
1. Previous diagnosis of diabetes according to World Health Organisation (WHO) 1999 criteria
2. Previous intensive treatment for IGT 3. Previous participation in a programme of vigorous physical activity |
| Anticipated start date | 20/07/2000 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 104 recruited as of 09/09/2003 |
| Interventions |
The study is a parallel design, randomised controlled study with one intervention arm and one control arm. Individuals with IGT are randomly allocated to receive either intensive behavioural intervention to promote dietary modification and increased physical activity or a control group which will receive minimal intervention consisting of widely available information on healthy lifestyle.
Sponsor for the follow-up study: Newcastle upon Tyne Hospitals NHS Foundation Trust Joint Research Office Level 6, Leazes Wing Royal Victoria Infirmary Queen Victoria Road Newcastle upon Tyne NE1 4LP Tel: 0191 282 5959 Fax: 0191 282 4524 e-mail: amanda.tortice@ncl.ac.uk |
| Primary outcome measure(s) |
Current primary outcome measure as of 26/01/2009:
Incidence of diabetes confirmed by two OGTTs (between one and 12 weeks apart). Previous primary outcome measure: Changes in new diabetes confirmed on two OGGTs |
| Secondary outcome measure(s) |
Current secondary outcome measures as of 26/01/2009:
Changes in: 1. Weight 2. Physical activity 3. Dietary fibre intake 4. Carbohydrate intake as a percentage of total dietary energy 5. Fat intake as a percentage of total dietary energy Previous secondary outcome measures: 1. The proportion of energy consumed from fat, protein, carbohydrates and saturated, monounsaturated, polyunsaturated fatty acids, fibre and cholesterol 2. Physical activity 3. Glucose tolerance 4. Insulin sensitivity 5. Cardiovascular risk factors 6. Cardiovascular morbidity and mortality 7. Quality of life |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 057146) |
| Trial website | http://www.newcastle-hospitals.org.uk/hospitals/royal-victoria-infirmary.aspx |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19758428 |
| Contact name | Prof Martin White |
| Address |
Institute of Health and Society
Baddiley-Clark building Richardson Road |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE2 4AX |
| Country | United Kingdom |
| Tel | +44 (0)191 222 6275 |
| Fax | +44 (0)191 222 6461 |
| Martin.White@ncl.ac.uk | |
| Sponsor | Newcastle Primary Care Trust (UK) |
| Address | Benfield Road 00A |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE6 4PF |
| Country | United Kingdom |
| Tel | +44 (0)191 219 6000 |
| Fax | +44 (0)191 219 6066 |
| alison.emslie@newacstle-pct.nhs.uk | |
| Sponsor website: | http://www.newcastlepct.nhs.uk |
| Date applied | 14/10/2005 |
| Last edited | 25/10/2011 |
| Date ISRCTN assigned | 14/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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