Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial
Abstract Background The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabe...
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| Format: | Article |
| Language: | English |
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BMC
2021-08-01
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| Series: | BMC Medicine |
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| Online Access: | https://doi.org/10.1186/s12916-021-02053-x |
| _version_ | 1819096527138717696 |
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| author | Michael Sampson Allan Clark Max Bachmann Nikki Garner Lisa Irvine Amanda Howe Colin Greaves Sara Auckland Jane Smith Jeremy Turner Dave Rea Gerry Rayman Ketan Dhatariya W. Garry John Garry Barton Rebecca Usher Clare Ferns Melanie Pascale on behalf of the NDPS group |
| author_facet | Michael Sampson Allan Clark Max Bachmann Nikki Garner Lisa Irvine Amanda Howe Colin Greaves Sara Auckland Jane Smith Jeremy Turner Dave Rea Gerry Rayman Ketan Dhatariya W. Garry John Garry Barton Rebecca Usher Clare Ferns Melanie Pascale on behalf of the NDPS group |
| author_sort | Michael Sampson |
| collection | DOAJ |
| description | Abstract Background The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes. Methods We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months. Results We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference −2.57 mmol/mol; 95% CI −4.5, −0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (−0.55 mmol/mol; 95% CI −2.46, 1.35; p = 0.57), or INT vs CON arms (−2.14 mmol/mol; 95% CI −4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON −4.76 mmol/mol; 95% CI −7.75, −1.78 mmol/mol) than in older participants (−0.46 mmol/mol; 95% CI −2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (−6.01 mmol/mol; 95% CI −9.56, −2.46 age < 65 years old and −0.22 mmol/mol; 95% CI −2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (−7.0 mmol/mol; 95% CI −11.5, −2.5; p = 0.003). Conclusion The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months. Trial registration ISRCTN34805606 . Retrospectively registered 14.4.16 |
| first_indexed | 2024-12-22T00:00:36Z |
| format | Article |
| id | doaj.art-eebb7ce728764d41bc0d0aebef6377c4 |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-12-22T00:00:36Z |
| publishDate | 2021-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-eebb7ce728764d41bc0d0aebef6377c42022-12-21T18:45:42ZengBMCBMC Medicine1741-70152021-08-0119111710.1186/s12916-021-02053-xEffects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trialMichael Sampson0Allan Clark1Max Bachmann2Nikki Garner3Lisa Irvine4Amanda Howe5Colin Greaves6Sara Auckland7Jane Smith8Jeremy Turner9Dave Rea10Gerry Rayman11Ketan Dhatariya12W. Garry John13Garry Barton14Rebecca Usher15Clare Ferns16Melanie Pascale17on behalf of the NDPS groupElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustNorwich Medical School, University of East AngliaNorwich Medical School, University of East AngliaElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustNorwich Medical School, University of East AngliaNorwich Medical School, University of East AngliaSchool of Sport, Exercise & Rehabilitation Sciences, University of BirminghamElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustUniversity of Exeter Medical School, College of Medicine & Health, University of ExeterElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustDepartment of Diabetes and Endocrinology, Ipswich General Hospital NHS TrustElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustNorwich Medical School, University of East AngliaNorwich Medical School, University of East AngliaElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustElsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS TrustAbstract Background The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes. Methods We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months. Results We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference −2.57 mmol/mol; 95% CI −4.5, −0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (−0.55 mmol/mol; 95% CI −2.46, 1.35; p = 0.57), or INT vs CON arms (−2.14 mmol/mol; 95% CI −4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON −4.76 mmol/mol; 95% CI −7.75, −1.78 mmol/mol) than in older participants (−0.46 mmol/mol; 95% CI −2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (−6.01 mmol/mol; 95% CI −9.56, −2.46 age < 65 years old and −0.22 mmol/mol; 95% CI −2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (−7.0 mmol/mol; 95% CI −11.5, −2.5; p = 0.003). Conclusion The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months. Trial registration ISRCTN34805606 . Retrospectively registered 14.4.16https://doi.org/10.1186/s12916-021-02053-xType 2 diabetesScreen detectedLifestyle InterventionGlycaemic controlDiabetes Prevention MentorsPeer support |
| spellingShingle | Michael Sampson Allan Clark Max Bachmann Nikki Garner Lisa Irvine Amanda Howe Colin Greaves Sara Auckland Jane Smith Jeremy Turner Dave Rea Gerry Rayman Ketan Dhatariya W. Garry John Garry Barton Rebecca Usher Clare Ferns Melanie Pascale on behalf of the NDPS group Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial BMC Medicine Type 2 diabetes Screen detected Lifestyle Intervention Glycaemic control Diabetes Prevention Mentors Peer support |
| title | Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial |
| title_full | Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial |
| title_fullStr | Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial |
| title_full_unstemmed | Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial |
| title_short | Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial |
| title_sort | effects of the norfolk diabetes prevention lifestyle intervention ndps on glycaemic control in screen detected type 2 diabetes a randomised controlled trial |
| topic | Type 2 diabetes Screen detected Lifestyle Intervention Glycaemic control Diabetes Prevention Mentors Peer support |
| url | https://doi.org/10.1186/s12916-021-02053-x |
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