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 to a new study.
The Norfolk Diabetes Prevention Study (NDPS) is the largest diabetes prevention research study in the world in the last 30 years.
Results from the eight-year clinical trial, which involved over 1,000 people with prediabetes at high risk of developing Type 2 diabetes, have just been published in the international journal JAMA Internal Medicine.
Researchers 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 per cent for those categorised as having prediabetes.
There are about eight million people with prediabetes in the UK and 4.5 million have already developed Type 2 diabetes. Researchers at the University of Birmingham and Exeter contributed to the NDPS, which was funded by £2.5m from the National Institute for Health Research (NIHR), and NIHR CRN Eastern and led by the Norfolk and Norwich University Hospital (NNUH) and University of East Anglia (UEA) .
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 can make a difference in helping people reduce risk of Type 2 (adult onset) diabetes.
Professor Mike Sampson, NDPS Chief Investigator and Consultant in Diabetes at NNUH, said:
“We are delighted with the results of this trial, as until now no one was very sure if a real-world lifestyle programme 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.”
NDPS ran between 2011 and 2018 and found 144,000 people at risk of developing Type 2 diabetes. In screening sites across the East of England, 13,000 of these people then took a fasting glucose and glycosylated haemoglobin (HbA1c) blood test to detect prediabetes. More than 1,000 people with prediabetes were then entered into a randomised controlled trial, testing a pragmatic real-world lifestyle intervention, compared to a control group, with average follow-up of just over two years.
Earlier studies used intense and expensive research interventions in different groups of prediabetes participants, but this is the first time a real world group-delivered intervention has been shown to reduce the risk of Type 2 diabetes.
Colin Greaves, Professor of Psychology Applied to Health at University of Birmingham, who jointly led the development of the NDPS intervention, said:
“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.”
Max Bachmann, NDPS co-investigator and Professor of Health Services Research at University of East Anglia, said:
“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. For every 11 people who received the NDPS intervention, one person was prevented from getting Type 2 diabetes, which is a real breakthrough."
Dr Jane Smith, NDPS collaborator from the University of Exeter, added: “Type 2 diabetes is a huge health challenge globally. NDPS is an incredibly positive story for individuals and healthcare systems, and underlines the importance of providing national diabetes prevention programmes, which can use our research findings.”
Dr Elizabeth Robertson, Director of Research at Diabetes UK, commented:
“We welcome this new research showing that a group-based support programme can help people at high risk of developing type 2 diabetes reduce their risk. This trial again highlights how achieving modest weight loss through diet and physical activity changes can lead to huge benefits for people at high risk of developing type 2. Type 2 diabetes is a serious condition, but with the right help many cases can be prevented or delayed.”
- The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
- ‘Lifestyle Intervention With or Without Lay Volunteers to Prevent Type 2 Diabetes in People With Impaired Fasting Glucose and/or Nondiabetic Hyperglycemia: A Randomized Clinical Trial’ - Sampson M, Clark A, Bachmann M, Garner N, Irvine L, Howe A, Greaves C,Auckland S, Smith J, Turner J, Rea D, Rayman G, Dhatariya K, John WG, Barton G, Usher R, Ferns C, Pascale M; Norfolk Diabetes Prevention Study (NDPS) Group is published in JAMA Internal Medicine.doi:10.1001/jamainternmed.2020.5938. Epub ahead of print. PMID: 33136119.
November 2, 2020
Lifestyle Intervention With or Without Lay Volunteers to Prevent Type 2 Diabetes in People With Impaired Fasting Glucose and/or Nondiabetic HyperglycemiaA Randomized Clinical Trial
Michael Sampson, MD1,2; Allan Clark, PhD2; Max Bachmann, PhD2; et alNikki Garner, MPhil1; Lisa Irvine, PhD2; Amanda Howe, MD2; Colin Greaves, PhD3,4; Sara Auckland, PhD1; Jane Smith, PhD2,4; Jeremy Turner, DPhil1; Dave Rea1; Gerry Rayman, MD5; Ketan Dhatariya, PhD1; W. Garry John, PhD6; Garry Barton, PhD2; Rebecca Usher, MSc1; Clare Ferns1; Melanie Pascale, PhD1; for the Norfolk Diabetes Prevention Study (NDPS) Group
JAMA Intern Med. Published online November 2, 2020. doi:10.1001/jamainternmed.2020.5938
Question Does a group-based lifestyle intervention (with or without trained volunteers with type 2 diabetes) reduce the risk of type 2 diabetes in people with current high-risk intermediate glycemic categories of impaired fasting glucose or nondiabetic hyperglycemia?
Finding In this randomized clinical trial of 1028 participants with high-risk intermediate glycemic categories, the intervention significantly reduced the 2-year risk of type 2 diabetes by 40% to 47%, although lay volunteer support did not reduce the risk further. For every 11 participants treated, 1 diabetes diagnosis was prevented.
Meaning Nearly half of the adult population has diabetes or a high-risk glycemic category, and this low-cost group-delivered intervention significantly reduced the risk of diabetes.
Importance Nearly half of the older adult population has diabetes or a high-risk intermediate glycemic category, but we still lack trial evidence for effective type 2 diabetes prevention interventions in most of the current high-risk glycemic categories.
Objective To determine whether a group-based lifestyle intervention (with or without trained volunteers with type 2 diabetes) reduced the risk of progression to type 2 diabetes in populations with a high-risk glycemic category.
Design, Setting, and Participants The Norfolk Diabetes Prevention Study was a parallel, 3-arm, group-based, randomized clinical trial conducted with up to 46 months of follow-up from August 2011 to January 2019 at 135 primary care practices and 8 intervention sites in the East of England.
We identified 141 973 people at increased risk of type 2 diabetes, screened 12 778 (9.0%), and randomized those with a high-risk glycemic category, which was either an elevated fasting plasma glucose level alone (≥110 and <126 mg/dL [to convert to millimoles per liter, multiply by 0.0555]) or an elevated glycated hemoglobin level (≥6.0% to <6.5%; nondiabetic hyperglycemia) with an elevated fasting plasma glucose level (≥100 to <110 mg/dL).
Interventions A control arm receiving usual care (CON), a theory-based lifestyle intervention arm of 6 core and up to 15 maintenance sessions (INT), or the same intervention with support from diabetes prevention mentors, trained volunteers with type 2 diabetes (INT-DPM).
Main Outcomes and Measures Type 2 diabetes incidence between arms
Results In this study, 1028 participants were randomized (INT, 424 [41.2%] [166 women (39.2%)]; INT-DPM, 426 [41.4%] [147 women (34.5%)]; CON, 178 [17.3%] [70 women (%39.3)]) between January 1, 2011, and February 24, 2017. The mean (SD) age was 65.3 (10.0) years, mean (SD) body mass index 31.2 (5) (calculated as weight in kilograms divided by height in meters squared), and mean (SD) follow-up 24.7 (13.4) months.
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 (odds ratio [OR], 1.14; 95% CI, 0.77-1.7; P = .51), but each intervention arm had significantly lower odds of type 2 diabetes (INT: OR, 0.54; 95% CI, 0.34-0.85; P = .01; INT-DPM: OR, 0.61; 95% CI, 0.39-0.96; P = .033; combined: OR, 0.57; 95% CI, 0.38-0.87; P = .01). The effect size was similar in all glycemic, age, and social deprivation groups, and intervention costs per participant were low at $153 (£122).
Conclusions and Relevance The Norfolk Diabetes Prevention lifestyle intervention reduced the risk of type 2 diabetes in current high-risk glycemic categories. Enhancing the intervention with DPM did not further reduce diabetes risk. These translatable results are relevant for current diabetes prevention efforts.
Trial Registration ISRCTN Registry Identifier: ISRCTN34805606
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