Providing support to help people with prediabetes make small changes to their lifestyle, diet and physical activity can almost halve the risk of developing type 2 diabetes, according the results of the Norfolk Diabetes Prevention Study (NDPS) the largest diabetes prevention research study in the world in the last 30 years.
The findings of the NDPS clinical trial, which ran over eight years and involved more than 1,000 people with prediabetes at high risk of developing type 2 diabetes, have just been published in the paper, ‘Lifestyle Intervention With or Without Lay Volunteers to Prevent Type 2 Diabetes in People With Impaired Fasting Glucose and/or Nondiabetic Hyperglycemia’, in JAMA Internal Medicine.
"We are delighted with the results of this trial, as until now no one was very sure if a real-world lifestyle program prevented type 2 diabetes in the prediabetes population we studied, as there have been no clinical trials that had shown this. We have now shown a significant effect in type 2 diabetes prevention, and we can be very optimistic that even a modest weight loss, and an increase in physical activity, in real world programmes like this have a big effect on the risk of getting type 2 diabetes,” said Professor Mike Sampson, NDPS Chief Investigator and Consultant in Diabetes at NNUH. “This is really great news for the eight million people in the UK with a prediabetes diagnosis. The results of this trial show that diabetes prevention is possible in the same prediabetes populations being treated in the NHS national diabetes prevention program. This is important to know, as the clinical methods for diagnosing diabetes and prediabetes have changed a lot in recent years."
The study found that support to make modest lifestyle changes, including losing two to three kilograms of weight and increased physical activity over two years, reduced the risk of type 2 diabetes by 40 to 47 percent for those categorised as having prediabetes.
"The NDPS intervention was delivered in groups which was far less expensive than individual-focused interventions which have previously shown to be effective under optimal conditions,” added Professor Max Bachmann, NDPS co-investigator and Professor of Health Services Research at University of East Anglia. “For every 11 people who received the NDPS intervention, one person was prevented from getting type 2 diabetes, which is a real breakthrough"
It is estimated that there are about eight million people with prediabetes in the UK and 4.5 million have already developed type 2 diabetes. The NDPS, funded by £2.5m from the National Institute for Health Research (NIHR) and NIHR CRN Eastern, was led by the Norfolk and Norwich University Hospital (NNUH) and University of East Anglia (UEA), together with colleagues from Ipswich Hospital, and the Universities of Birmingham and Exeter.
The research trial tested a simple lifestyle intervention, which helped people make small achievable lifestyle changes that led to a modest weight loss and increases in physical activity. Importantly, these changes were sustained for at least two years and the weight lost was not put back on. These findings are important as they show that a ‘real-world’ lifestyle programme really can make a difference in helping people reduce their risk of type 2 (adult onset) diabetes.
The study was a parallel, three-arm, group-based, randomised clinical trial conducted with up to 46 months of follow-up from August 2011 to January 2019 at 135 primary care practices and eight intervention sites in the East of England. They identified 141,973 people at increased risk of type 2 diabetes, screened 12,778 (9.0%) people and randomised those with a high-risk glycaemic category, which was either an elevated fasting plasma glucose level alone (≥110 and <126 mg/dL [to convert to millimoles per litre, multiply by 0.0555]) or an elevated glycated haemoglobin level (≥6.0% to <6.5%; nondiabetic hyperglycaemia) with an elevated fasting plasma glucose level (≥100 to <110 mg/dL).
In total, 1,028 participants were enrolled to a control arm receiving usual care (CON, n=178 [17.3%] [70 women (%39.3)]), a theory-based lifestyle intervention arm of six core and up to 15 maintenance sessions (INT, n=424 [41.2%] [166 women (39.2%)]) or the same intervention with support from diabetes prevention mentors, trained volunteers with type 2 diabetes (INT-DPM, n=426 [41.4%] [147 women (34.5%)].
A total of 156 participants progressed to type 2 diabetes, which comprised 39 of 171 receiving CON (22.8%), 55 of 403 receiving INT (13.7%), and 62 of 414 receiving INT-DPM (15.0%). There was no significant difference between the intervention arms in the primary outcome (p=0.51), but each intervention arm had significantly lower odds of type 2 diabetes (p=0.01; INT-DPM, p=0.033; combined: p=0.01). The effect size was similar in all glycaemic, age and social deprivation groups, and intervention costs per participant were low at US$153 (£122).
"If you have been diagnosed with prediabetes, this approach offers a way to take a different direction in your life - to get off the path to type 2 diabetes and onto the road to a healthier future," commented professor Colin Greaves, Professor of Psychology Applied to Health at University of Birmingham, who jointly led the development of the NDPS intervention.
Professor Jonathan Valabhji, national clinical director for Diabetes and Obesity, said: "This study with similar referral criteria and a similar intensive lifestyle intervention to the NHS Diabetes Prevention Program has surpassed expectations in preventing type 2 diabetes. This is hugely encouraging for the NHS Diabetes Prevention Program, and what participants might expect to achieve in the longer term."
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