Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/04/2016
Date assigned
14/04/2016
Last edited
14/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Type 2 diabetes is a condition where the concentration of glucose (sugar) in the blood is high, which may over time increase the risk of heart disease and damage to the blood vessels, nerves, eyes and kidneys. There are two types of diabetes - type 1 (which usually develops before the age of 40) and type 2 (adult onset, which is usually diagnosed over the age of 40). There are now more than 3 million people with type 2 diabetes in the UK, and many people with this condition pass through a stage where their blood sugar levels are elevated, but not quite to the level that means they have diabetes. This stage is sometimes called 'pre diabetes', and the aim of this study is to see if the risk of progressing from 'pre diabetes' to full diabetes can be reduced.

Who can participate?
We plan to check about 10,000 people for 'pre diabetes' with a blood test, and to find about 950 people with pre diabetes and about 300 people who have diabetes without knowing it.

What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group attend a single dietary and lifestyle education session which will last for 2 hours. Participants in the second group attend about 21 sessions over 4 years, including both education sessions and exercise classes. Participants in the third group attend the 21 sessions and also receive extra help and support from people with diabetes who have been trained to give diet and lifestyle advice. All participants provide blood samples to measure blood glucose levels at the start of the study and after 6, 12, 24, 36, 40 and 46 months. We also record the views of all participants on the value of this programme.

What are the possible benefits and risks of participating?
Detecting diabetes or ‘pre-diabetes’ in this way could offer some medical benefits as early detection allows early treatment and intervention. There are minimal risks associated with taking part in this study. Some people will be diagnosed with diabetes or ‘pre-diabetes’, which can be a shock, but the study team will be available to provide support and their GP will also be informed. There may be some discomfort from the needle prick when the blood samples are taken but this should ease almost immediately after the blood test. There may be a small bruise at the site of the needle prick but again this should fade quite quickly. Anyone who takes part in physical exercise can be at risk of common injuries. This risk can be reduced by gradually building up your levels of activity their own pace and patients will be guided by qualified fitness facilitators.

Where is the study run from?
The project is being run from the Clinical Research and Trials Unit (CRTU) at the University of East Anglia (UEA) in Norwich, and is running at several sites NHS hospitals and general practices in the East of England.

When is the study starting and how long is it expected to run for?
April 2011 to July 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Dr Melanie Pascale (melanie.pascale@nnuh.nhs.uk)
2. Prof. Mike Sampson

Trial website

www.norfolkdiabetespreventionstudy.nhs.uk

Contact information

Type

Public

Primary contact

Dr Melanie Pascale

ORCID ID

Contact details

NHS Clinical Research and Trials Unit
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 597284
melanie.pascale@nnuh.nhs.uk

Type

Scientific

Additional contact

Prof Mike Sampson

ORCID ID

Contact details

Norfolk and Norwich University Hospital
Norwich
NR94HN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 13.0 2nd Sepember 2014

Study information

Scientific title

Delivering a realistic diabetes prevention programme in a UK community: the Norfolk Diabetes Prevention Study (Norfolk DPS)

Acronym

NorfolkDPS/NDPS

Study hypothesis

The primary hypothesis which this programme will test is that the novel diet and lifestyle intervention programme that we have developed will significantly reduce the risk of developing type 2 diabetes (T2DM) compared to standard care in participants with impaired fasting glucose (IFG).

Ethics approval

Essex 1 RES, 13/01/2011, ref: 10/H0301/55

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

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

Condition

Type 2 diabetes, non-diabetic hyperglycaemia, impaired glucose regulation (IGR)

Intervention

The study design involves an NHS primary care based screening programme to detect and screen 10,000 subjects at increased risk of Type 2 diabetes, with randomisation of 'pre diabetes' groups into three arms (3:7:7 ratio):
1. A control group
2. An intervention group
3. An intervention group supplemented with additional support from lay trainers

Subjects with screen-detected Type 2 diabetes are also randomised into these intervention groups. The programme is coordinated from CRTU@UEA Norwich and the Norfolk and Norwich University Hospital, Norwich. Recruitment and intervention takes place at multiple sites across the East of England

Participants randomised into the intervention group(s) will initially attend 6 x 2 hour education session run by one Diabetes Prevention Faciliator (DPF). These 6 sessions are group sessions with randomised participants and will include:
1. An introduction to the programme, and to introduce the definitions of IFG and T2DM
2. The importance of diet and physical activity
3. Information session about exercise
4. Behavioural change
5. A review and evaluation of what participants have achieved, and whether their expectations have been met
6. How to plan to go forward after the programme ends
7. Explanation of future intervention sessions

Each education session will last 2 hours (12 hours total) and will take place every two weeks at the University of East Anglia (UEA) or at an alternative assessed site. After completing the education sessions, participants will attend up to 15 less intensive maintenance sessions which include exercise classes run by one DPF and one physiotherapist, over a follow-up period of up to 3.25 years. Each maintenance session will last for 2.5 hours and will take place every 8 weeks (total 37.5hrs) at the UEA or an alternative assessed site.

Staff called ‘Diabetes Prevention Facilitators’ (DPFs), will be recruited from multidisciplinary backgrounds to run the lifestyle part of the intervention and will work alongside specialised physical activity facilitators who will lead exercise sessions. More detailed information on the content of these sessions is given below, but overall we aim to encourage people to lose up to
7% of their body weight through a reduced fat intake and increased physical activity (largely walking).

A unique part of the Norfolk DPS will involve the recruiting and training of members of the public already diagnosed with T2DM to be lifestyle mentors, known as Diabetes Prevention Mentors (DPMs). In the intervention group with DPM, each participant also receives a 15-minute semi-structured telephone call from the DPM every 4 weeks during the education session phase (first twelve weeks of programme) and then every 8 weeks in between their maintenance and exercise sessions.

The control group will receive a single dietary and lifestyle education session which will last for 2 hours and which will take place at the UEA, NNUHFT or an alternative assessed site.

The participants in both intervention groups will have blood samples taken for FPG and HbA1c at: baseline (0) , 6, 12, 24, 36, 40 and exit (46 months). We will record the views of all participants in the Norfolk DPS using qualitative and quantitative methods on the value of this programme which will be used as part of the evaluation process.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Project 2 (prediabetes study):
Progression to type 2 diabetes (T2DM), determined by fasting plasma glucose analysis and/or HbA1c analysis, at baseline, 4 months, 6 months, 12 months, 24 months, 36 months 40 months, 46 months (EXIT).

Project 4 (diabetes study):
Difference in mean HbA1c at timepoints and Quality and Outcomes Framework (QOF) scores for diabetes based on the diabetes QoF dataset. QOF – target is based on 7.5% (58mmol/mol and 10% (86mmol/mol) HbA1 thresholds – we describe % above and below these thresholds by arm.

Secondary outcome measures

The secondary outcome measures are measured at baseline, 4 months, 6 months, 12 months, 24 months, 36 months 40 months and 46 months:

Project 2 (prediabetes study):
1. Change from baseline in HOMA estimate of insulin sensitivity
2. Change from baseline in HOMA estimate of B-cell function
3. Change from baseline in physical activity (objectively measured by accelerometer)
4. Change from baseline in physical activity (self-reported short form IPAQ questionnaire)
5. Change from baseline in resistance activity (self reported study specific questionnaire)
6. Change from baseline in dietary behaviour (self-reported by DBQ study specific designed questionnaire) change from baseline in weight
7. Change from baseline in BMI
8. Change from baseline in waist circumference
9. Change from baseline in body fat %
10. Change from baseline in body fat (kg)
11. Change from baseline in visceral fat
12. Change from baseline in WBQ12
13. Change from baseline in ADDQoL
14. Composite score of changes in weight, BMI, waist circumference and exercise levels

Project 4 (diabetes study):
1. Change from baseline in HOMA estimate of insulin sensitivity
2. Change from baseline in HOMA estimate of B-cell function
3. Change from baseline in physical activity (objectively measured by accelerometer)
4. Change from baseline in physical activity (self-reported short form IPAQ questionnaire)
5. Change from baseline in resistance activity (self reported study specific questionnaire)
6. Change from baseline in dietary behaviour (self-reported by DBQ study specific designed questionnaire)
7. Change from baseline in weight
8. Change from baseline in BMI
9. Change from baseline in waist circumference,
10. Change from baseline in body fat %
11. Change from baseline in body fat (kg)
12. Change from baseline in visceral fat
13. Change from baseline in WBQ12
14. Change from baseline in ADDQoL
15. Change from baseline in EQ-5D
16. Change from baseline in DMSES
17. Change from baseline in DTSQs
18. Composite score of changes in weight, BMI, waist circumference and exercise levels

Overall trial start date

01/04/2011

Overall trial end date

01/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Fasting plasma glucose 5.6 - 6.0 mmol/l AND HbA1c 42 - 47 inclusive on two occasions, OR fasting plasma glucose 6.1 - 6.9 inclusive on two occasions, both categories for the diabetes prevention project
2. Fasting plasma glucose > or = to 7.0 mmol/l on two occasions, OR HbA1c > or = to 48 mmol/mol on two occasions for the screen-detected Type 2 diabetes project
3. These criteria are gender independent, but main search criteria for subjects through primary care databases is 40 - 80 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000 in diabetes prevention project; 330 in screen detected Type 2 diabetes project

Participant exclusion criteria

1. Not able to provide GP details i.e. not registered with a GP or unwilling for their GP to be contacted
2. Unable to give informed consent due to lack of capacity through severe mental health, learning difficulties or significant cognitive impairment
3. Self-reported conditions which could adversely affect the trial results or patient clinical well being such as:
3.1. Terminal illness
3.2. Antipsychotic medication, which may affect glucose tolerance
3.3. High dose oral steroids (> 4 weeks or > 7.5 mg)
3.4. Active treatment for malignancy
3.5. Stage IV renal impairment or ongoing renal dialysis
3.6. Pregnant or lactating
3.7. Stage IV NYHA cardiac failure
4. Taking part in any research study which involves a dietary or lifestyle change intervention (exceptions are participants in observational research studies and EPIC*). Participation in other research studies will be assessed on an individual basis
5. Inability to attend or comply with the interventions or follow-up scheduling
6. Living with or related to someone in the programme team
7. GP advice on health grounds that the participant should not take part or be contacted

Recruitment start date

01/04/2011

Recruitment end date

01/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital NHS Trust and University of East Anglia
Colney Lane
Norwich
NR9 4HN
United Kingdom

Trial participating centre

Thetford Community Healthy Living Centre
Croxton Rd
Thetford
IP24 1JD
United Kingdom

Trial participating centre

James Paget University Hospital
Lowestoft Rd
Gorleston-on-Sea, Great Yarmouth, Norfolk
NR31 6LA
United Kingdom

Trial participating centre

Ipswich Hospital
Heath Rd
Ipswich, Suffolk
IP4 5PD
United Kingdom

Trial participating centre

St James' Clinic Norfolk Community Healthcare Trust
Extons Road
King's Lynn, Norfolk
PE30 5NU
United Kingdom

Trial participating centre

Rosedale Surgery
Ashburnham Way
Lowestoft
NR33 8LG
United Kingdom

Trial participating centre

Colchester Medical Practice
52 Wimpole Road
Colchester, Essex
CO1 2DL
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospital NHS Trust (UK)

Sponsor details

Colney Lane
Norwich
NR4 7UY
United Kingdom
+44 (0)1603 286286
lisa.chalkley@nnuh.nhs.uk

Sponsor type

Government

Website

www.nnuh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes