Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Tracey Scarpello

ORCID ID

Contact details

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4832

Study information

Scientific title

Acronym

DRN135 (Diabetes Prevention Programme: UEA-IFG Study)

Study hypothesis

This two year feasibility programme will screen for participants at risk of diabetes (impaired fasting glucose). For those participants at risk of diabetes, the second stage of the programme will be to investigate whether a structured diet and lifestyle programme (called UEA-IFG) can be developed and whether the programme reduces the risk of Type 2 Diabetes Mellitus. The end stage would be to develop a full RCT to test the intervention programme fully.

Ethics approval

MREC approved (ref: 08/H0301/102)

Study design

Single centre randomised interventional prevention and screening trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: All Diseases, Prevention/screening

Intervention

Diabetes Prevention Programme: Lifestyle programme based on the U.S. Diabetes Prevention Programme. Participant targets will be to:
1. Lose 7% of body weight
2. Build up to 2.5 hours of brisk physical activity each week
3. Build up to walking at least 10,000 steps a day
4. Eat more healthily by eating less fat

Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Transition to type 2 diabetes mellitus (fasting plasma glucose of 7.0 mmol/l or greater) after 17 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/12/2008

Overall trial end date

14/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female
2. Aged 45 - 70 years
3. One of the following:
3.1. First degree relative with type 2 diabetes
3.2. Body mass index (BMI) greater than 25 kg/m2
3.3. Waist circumference greater than 94 cm (male) or greater than 80 cm (female)
3.4. History of gestational diabetes
3.5. History of coronary heart disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 870; UK sample size: 870

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

08/12/2008

Recruitment end date

14/01/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Colney Lane
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)

Sponsor details

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Sponsor type

Government

Website

http://www.nnuh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes