Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening

Abstract

BackgroundEarlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus (T2DM). Latent phase identification through screening requires structured, appropriately targeted population-based approaches. Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from randomised intervention trials in screen-detected T2DM cases. UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM. To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care. Here we describe the rationale and methods of a systematic community screening programme and randomised controlled trial of cardiovascular risk management within a UK multiethnic setting (ADDITION-Leicester).DesignA single-blind cluster randomised, parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care.MethodsADDITION-Leicester consists of community-based screening and intervention phases within 20 general practices coordinated from a single academic research centre. Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40-75 years (25-75 years South Asian). Volunteers also provide detailed medical and family histories; complete health questionnaires, undergo anthropometric measures, lipid profiling and a proteinuria assessment. Primary outcome is reduction in modelled Coronary Heart Disease (UKPDS CHD) risk at five years. Seven thousand (30% of South Asian ethnic origin) volunteers over three years will be recruited to identify a screen-detected T2DM cohort (n = 285) powered to detected a 6% relative difference (80% power, alpha 0.05) between treatment groups at one year. Randomisation will occur at practice-level with newly diagnosed T2DM cases receiving either conventional (according to current national guidelines) or intensive (algorithmic target-driven multi-factorial cardiovascular risk intervention) treatments.DiscussionADDITION-Leicester is the largest multiethnic (targeting >30% South Asian recruitment) community T2DM and vascular risk screening programme in the UK. By assessing feasibility and efficacy of T2DM screening, it will inform national disease prevention policy and contribute significantly to our understanding of the health care needs of UK South Asians.Trial registrationClinicaltrial.gov (NCT00318032).

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

“…The biochemical, anthropometric and demographic variables used in the present analyses were measured during the screening visit (14)(15)(16) . The primary outcome variable was type 2 diabetes diagnosed using the WHO 2011 guidelines as fasting glucose ≥7·0 mmol/l, 2 h glucose ≥11·1 mmol/l or glycated Hb (HbA1c) ≥6·5 % (48 mmol/ mol) (18) .…”

Impact of metabolic indices on central artery stiffness: independent association of insulin resistance and glucose with aortic pulse wave velocity

“…Volunteers were recruited from a population-based screening programme for diabetes mellitus [29,30]. ADDITIONEurope (Anglo-Danish-Dutch Trial of Intensive Treatment in Screen-Detected Diabetes) is a prospective intervention trial of multifactorial cardiovascular risk management in people with screen-detected type 2 diabetes with a primary endpoint of 5 year macrovascular events [31].…”

“…ADDITIONEurope (Anglo-Danish-Dutch Trial of Intensive Treatment in Screen-Detected Diabetes) is a prospective intervention trial of multifactorial cardiovascular risk management in people with screen-detected type 2 diabetes with a primary endpoint of 5 year macrovascular events [31]. As one of the UK arms, ADDITION-Leicester [29,30] cf PWV measurements Two operators (DRW and RS) blinded to glucose status performed all arterial measurements within a single-site research facility at a university teaching hospital. A standard protocol ensured participants were fasted and rested supine prior to cf PWV assessment.…”

Implementation of the automated Leicester Practice Risk Score in two diabetes prevention trials provides a high yield of people with abnormal glucose tolerance

“…The response rates and prevalences were compared with those found in the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care (ADDITION)-Leicester study [13]. ADDITIONLeicester used a population-based screening approach in the same locality as LPD and WAD.…”