A prevention programme for Type 2 Diabetes integrating identification, lifestyle intervention and community services

Plain English Summary

Background and study aims
Type 2 Diabetes Mellitus (T2DM) is an increasing chronic disease affecting over 2 million people in England alone. It shortens life and consumes 10% of NHS resources. At diagnosis many have established complications involving damage to the eyes, kidneys, feet and heart. There is a need to focus efforts to prevent this devastating disease. Certain factors such as being overweight, having a family history of diabetes or heart disease, having a previous history of raised blood sugar measurement or diabetes during pregnancy increase the risk of developing diabetes later in life. People who eat a high fat diet or have high blood pressure or smoke are also at high risk. When someone’s blood glucose levels are higher than normal but NOT high enough for a diagnosis of diabetes, we say they have pre-diabetes (it may also be referred to as Impaired Glucose Tolerance [IGT] or Impaired Fasting Glucose [IFG]), depending on which test was used to detect it. Pre-diabetes is a better way of explaining what it means to have higher than normal blood glucose levels. It means you are more likely to develop diabetes and may already be experiencing some health problems because of it. Just like someone with diabetes, if you have pre-diabetes, you are at higher risk of heart disease and/or stroke. If you are overweight, eating a high fat diet or are not very active, you could be increasing your risks. Some people who have diabetes in their family have an added risk factor. But there are things you can do to help yourself and the Let’s Prevent study is about helping us find out which of these are best. The good news is that everyone at risk of diabetes can do things to keep healthy and slow down or even stop the development of this serious disease. Recent studies have shown that lifestyle changes, such as being more active and changing your diet, could be more effective than medicines in helping to stop people developing Type 2 diabetes. But because we don’t yet know which of these ways of treating people is best, we need to compare them in a research study.

Who can participate?
Patients with •pre-diabetes•, aged 40 -– 75 if English-speaking European or 25 -– 75 if South Asian

What does the study involve?
People who have been identified as at risk will be invited to visit the diabetes research team at a local venue and this visit will take around 3 hours. We will participants to come to this visit fasting, but this does not obligate the person to take part. After an opportunity to meet the team and to ask any questions, informed consent will be taken. Following this, participants have oral glucose tolerance test (OGTT), blood tests (49ml of blood, this is the same as 10 teaspoons), body measurements, medical history, height/weight and blood pressure recorded. In between the two blood tests participants also complete a questionnaire about health, physical activity, eating habits and overall wellbeing. After this first visit, results will be analysed.
Only those with pre-diabetes enter into the main study and, depending on which GP surgery the participant attends, are randomly allocated to one of our two study groups. •Group 1 is what we call the ‘control’ group - receive the usual excellent care for pre-diabetes provided by their GP practice and some useful leaflets from us. •Group 2 is the ‘intensive’ group and will receive education sessions and continuous support to help the participant address the risks of developing diabetes. Regardless of which group the participant is in, once a year for the next 3 years, participants return for a full health screen, including an OGTT, height/weight and blood pressure readings.

What are the possible benefits and risks of participating?
We hope that all people in the study (who have already been identified as having pre-diabetes) will avoid progressing to diabetes. The information we get from this study may help us to prevent future people with pre-diabetes or at a high risk from developing the diabetes. Participants in this study will not be given any medication. Participants may suffer slight discomfort while the blood samples are being taken from their arm and some people do experience bruising after blood samples have been taken. The participant’s family doctor will be informed of all the results of the tests taken during the course of the study.

Where is the study run from?
The study is being conducted in Leicester, Leicestershire and Rutland (UK)

When is the study starting and how long is it expected to run for?
July 2009 to July 2014

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

Who is the main contact?
Stephanie Goldby
stephanie.goldby@uhl-tr.nhs.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

Website	http://www.uhl-tr.nhs.uk/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

26/01/2017: Publication reference added.
11/01/2017: Publication reference added.
13/07/2016: Publication reference added.
25/02/2013: The overall trial end date was changed from 01/01/2010 to 31/07/2014.