Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/10/2005
Date assigned
14/10/2005
Last edited
05/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Once of the main reasons why people develop T2DM is because they are overweight or obese. The increase in obesity in recent years has led to an increase in type 2 diabetes and it increasingly affects younger people as well. Many people who are overweight suffer from impaired glucose tolerance (IGT), a condition where blood sugar is raised but not enough for it to be classified as diabetes. People with IGT have a much greater risk of developing T2DM and so it is important to find an effective way of preventing this. Many studies have shown that losing weight, exercising more and eating a healthy, balanced diet all help to treat IGT and prevent it from developing into T2DM. The aim of this study is to find out whether a diet and exercise programme can help to prevent or delay the onset of T2M in people suffering from IGT.

Who can participate?
Overweight adults aged between 40 and 74 who have high blood sugar (IGT).

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group take part in an intensive programme designed to change their behaviour regarding diet and exercise. This involves attending a number of sessions with a trained dietician and a physiotherapist, in order to encourage calorie restriction, healthier eating and 30 minutes of moderate aerobic exercise (cardio) every day. Participants in the second group are given written standard health promotion advice about healthy eating and physical activity. At the start of the study and then again after 12 weeks, participants in both groups have their blood sugar levels, weight and diet and exercise habits measured in order to see if there have been any changes.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Institute of Health and Society, Newcastle upon Type (UK)

When is the study starting and how long is it expected to run for?
July 2000 December 2007

Who is funding the study?
Wellcome Trust (grant reference: 057146) (UK)

Who is the main contact?
Professor Martin White
Martin.White@ncl.ac.uk

Trial website

http://www.newcastle-hospitals.org.uk/hospitals/royal-victoria-infirmary.aspx

Contact information

Type

Scientific

Primary contact

Prof Martin White

ORCID ID

Contact details

Institute of Health and Society
Baddiley-Clark building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
+44 191 222 6275
Martin.White@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

057146, N0565163209

Study information

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

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.

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes

Intervention

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

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

20/07/2000

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

104 recruited as of 09/09/2003

Participant 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

Recruitment start date

20/07/2000

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health and Society
Baddiley-Clark Bldg
Newcastle upon Tyne
NE2 4AX
United Kingdom

Sponsor information

Organisation

Newcastle Primary Care Trust

Sponsor details

Benfield Road 00A
Newcastle upon Tyne
NE6 4PF
United Kingdom
+44 191 219 6000
alison.emslie@newacstle-pct.nhs.uk

Sponsor type

Government

Website

http://www.newcastlepct.nhs.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18616797
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19758428

Publication citations

  1. Results

    Penn L, Moffatt SM, White M, Participants' perspective on maintaining behaviour change: a qualitative study within the European Diabetes Prevention Study., BMC Public Health, 2008, 8, 235, doi: 10.1186/1471-2458-8-235.

  2. Results

    Penn L, White M, Oldroyd J, Walker M, Alberti KG, Mathers JC, Prevention of type 2 diabetes in adults with impaired glucose tolerance: the European Diabetes Prevention RCT in Newcastle upon Tyne, UK., BMC Public Health, 2009, 9, 342, doi: 10.1186/1471-2458-9-342.

Additional files

Editorial Notes

05/02/2016: Plain English summary added. Verifying study status with principal investigator.