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The European Diabetes Prevention Study
ISRCTN ISRCTN15670600
DOI 10.1186/ISRCTN15670600
ClinicalTrials.gov identifier
EudraCT number
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 Lay summary under review 3
Ethics approval 1. Newcastle and North Tyneside NHS Joint Ethics Committee (Local Research Ethics Committee 1), 17/08/1999, ref: 99/186
2. Ethics approval for the follow-up study (EDIPS2) NRES Committee North East Newcastle and North Tyneside, 16/03/2011, ref: 11/NE/0036
Study design Multicentre parallel design randomised controlled study. Also from June 2011 a follow-up study at 10 years.
Countries of recruitment United Kingdom
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 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18616797
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
  Email 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
  Email alison.emslie@newacstle-pct.nhs.uk
  Sponsor website: http://www.newcastlepct.nhs.uk
Date applied 14/10/2005
Last edited 14/07/2014
Date ISRCTN assigned 14/10/2005
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