Intensive versus standard multifactorial cardiovascular risk factor control in screen-detected type 2 diabetes: 5-year and longer-term modelled outcomes of the ADDITION-Leicester study.

AIMS: Diabetes treatment algorithms recommend intensive intervention in those with a shorter duration of disease. Screening provides opportunities for earlier multifactorial cardiovascular risk factor control. Using data from the ADDITION-Leicester study (NCT00318032), we estimated the effects of this approach on modelled risk of diabetes-related complications in screen-detected patients. METHODS: A total of 345 (41% South Asian) people with screen-detected type 2 diabetes were cluster randomised to receive 5 years of (1) intensive multifactorial risk factor intervention or (2) standard treatment according to national guidance. Estimated 10 to 20-year risk of ischaemic heart disease, stroke, congestive cardiac failure, and death was calculated using UK-PDS risk equations. RESULTS: Compared with standard care, mean treatment differences for intensive management at 5 years were -11.7(95%CI: -15.0, -8.4) and -6.6(-8.8, -4.4) mmHg for systolic and diastolic blood pressure, respectively; -0.27 (-0.66, -0.26) % for HbA1c; and -0.46(-0.66; -0.26), -0.34 (-0.51; -0.18), and -0.19 (-0.28; -0.10) mmol/L for total cholesterol, LDL-cholesterol, and triglycerides, respectively. There was no significant weight gain in the intensive group despite additional medication use. Modelled risks were consistently lower for intensively managed patients. Absolute risk reduction associated with intensive treatment at 10 and 20 years were 3.5% and 6.2% for ischaemic heart disease and 6.3% and 8.8% for stroke. Risk reduction for congestive heart failure plateaued after 15 years at 5.3%. No differences were observed for blindness and all-cause death. CONCLUSION: Intensive multifactorial intervention in a multi-ethnic population with screen-detected type 2 diabetes results in sustained improvements in modelled ischaemic heart disease, stroke, and congestive cardiac failure.

The association between air pollution and type 2 diabetes in a large cross-sectional study in Leicester: The CHAMPIONS Study.

BACKGROUND: Observational evidence suggests there is an association between air pollution and type 2 diabetes; however, there is high risk of bias. OBJECTIVE: To investigate the association between air pollution and type 2 diabetes, while reducing bias due to exposure assessment, outcome assessment, and confounder assessment. METHODS: Data were collected from 10,443 participants in three diabetes screening studies in Leicestershire, UK. Exposure assessment included standard, prevailing estimates of outdoor nitrogen dioxide and particulate matter concentrations in a 1×1km area at the participant's home postcode. Three-year exposure was investigated in the primary analysis and one-year exposure in a sensitivity analysis. Outcome assessment included the oral glucose tolerance test for type 2 diabetes. Confounder assessment included demographic factors (age, sex, ethnicity, smoking, area social deprivation, urban or rural location), lifestyle factors (body mass index and physical activity), and neighbourhood green space. RESULTS: Nitrogen dioxide and particulate matter concentrations were associated with type 2 diabetes in unadjusted models. There was no statistically significant association between nitrogen dioxide concentration and type 2 diabetes after adjustment for demographic factors (odds: 1.08; 95% CI: 0.91, 1.29). The odds of type 2 diabetes was 1.10 (95% CI: 0.92, 1.32) after further adjustment for lifestyle factors and 0.91 (95% CI: 0.72, 1.16) after yet further adjustment for neighbourhood green space. The associations between particulate matter concentrations and type 2 diabetes were also explained away by demographic factors. There was no evidence of exposure definition bias. CONCLUSIONS: Demographic factors seemed to explain the association between air pollution and type 2 diabetes in this cross-sectional study. High-quality longitudinal studies are needed to improve our understanding of the association.

Development of a lifestyle intervention using the MRC framework for diabetes prevention in people with impaired glucose regulation.

BACKGROUND: We report development of a group-based lifestyle intervention, Let's Prevent, using the UK Medical Research Council (MRC) framework, and delivered by structured education to prevent type 2 diabetes mellitus (T2DM) in people with impaired glucose regulation (IGR) in a UK multi-ethnic population. METHODS: Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) is the first national T2DM programme that meets National Institute for Health and Care Excellence criteria and formed the basis for Let's Prevent. An iterative cycle of initial development, piloting, collecting and collating qualitative and quantitative data, and reflection and modification, was used to inform and refine lifestyle intervention until it was fit for evaluation in a definitive randomized controlled trial (RCT). The programme encouraged IGR self-management using simple, non-technical language and visual aids. RESULTS: Qualitative and quantitative data suggested that intervention resulted in beneficial short-term behaviour change such as healthier eating patterns, improved health beliefs and greater participant motivation and empowerment. We also demonstrated that recruitment strategy and data collection methods were feasible for RCT implementation. CONCLUSIONS: Let's Prevent was developed following successful application of MRC framework criteria and the subsequent RCT will determine whether it is feasible, reliable and transferable from research into a real-world NHS primary healthcare setting. TRIAL REGISTRATION: ISRCTN80605705.

PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial.

BACKGROUND: The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes. METHODS/DESIGN: A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change. DISCUSSION: This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention. TRIAL REGISTRATION: ISRCTN83465245 Trial registration date: 14/06/2012.

Is the number of fast-food outlets in the neighbourhood related to screen-detected type 2 diabetes mellitus and associated risk factors?

OBJECTIVE: We investigated whether a higher number of fast-food outlets in an individual's home neighbourhood is associated with increased prevalence of type 2 diabetes mellitus and related risk factors, including obesity. DESIGN: Cross-sectional study. SETTING: Three UK-based diabetes screening studies (one general population, two high-risk populations) conducted between 2004 and 2011. The primary outcome was screen-detected type 2 diabetes. Secondary outcomes were risk factors for type 2 diabetes. SUBJECTS: In total 10 461 participants (mean age 59 years; 53% male; 21% non-White ethnicity). RESULTS: There was a higher number of neighbourhood (500 m radius from home postcode) fast-food outlets among non-White ethnic groups (P<0.001) and in socially deprived areas (P<0.001). After adjustment (social deprivation, urban/rural, ethnicity, age, sex), more fast-food outlets was associated with significantly increased odds for diabetes (OR=1.02; 95% CI 1.00, 1.04) and obesity (OR=1.02; 95% CI 1.00, 1.03). This suggests that for every additional two outlets per neighbourhood, we would expect one additional diabetes case, assuming a causal relationship between the fast-food outlets and diabetes. CONCLUSIONS: These results suggest that increased exposure to fast-food outlets is associated with increased risk of type 2 diabetes and obesity, which has implications for diabetes prevention at a public health level and for those granting planning permission to new fast-food outlets.

The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study.

OBJECTIVE: To investigate the relationship between neighbourhood greenspace and type 2 diabetes. DESIGN: Cross-sectional. SETTING: 3 diabetes screening studies conducted in Leicestershire, UK in 2004-2011. The percentage of greenspace in the participant's home neighbourhood (3 km radius around home postcode) was obtained from a Land Cover Map. Demographic and biomedical variables were measured at screening. PARTICIPANTS: 10,476 individuals (6200 from general population; 4276 from high-risk population) aged 20-75 years (mean 59 years); 47% female; 21% non-white ethnicity. MAIN OUTCOME MEASURE: Screen-detected type 2 diabetes (WHO 2011 criteria). RESULTS: Increased neighbourhood greenspace was associated with significantly lower levels of screen-detected type 2 diabetes. The ORs (95% CI) for screen-detected type 2 diabetes were 0.97 (0.80 to 1.17), 0.78 (0.62 to 0.98) and 0.67 (0.49 to 0.93) for increasing quartiles of neighbourhood greenspace compared with the lowest quartile after adjusting for ethnicity, age, sex, area social deprivation score and urban/rural status (Ptrend=0.01). This association remained on further adjustment for body mass index, physical activity, fasting glucose, 2 h glucose and cholesterol (OR (95% CI) for highest vs lowest quartile: 0.53 (0.35 to 0.82); Ptrend=0.01). CONCLUSIONS: Neighbourhood greenspace was inversely associated with screen-detected type 2 diabetes, highlighting a potential area for targeted screening as well as a possible public health area for diabetes prevention. However, none of the risk factors that we considered appeared to explain this association, and thus further research is required to elicit underlying mechanisms. TRIAL REGISTRATION NUMBER: This study uses data from three studies (NCT00318032, NCT00677937, NCT00941954).