One in five adults in Sri Lanka has either diabetes or pre-diabetes and one-third of those with diabetes are undiagnosed.

BackgroundThere is an increasing incidence of type 2 diabetes mellitus (T2DM) in young urban South-Asians. We tested the effect of a pragmatic trimonthly lifestyle modification (LSM) programme (P-LSM) versus a less-intensive 12-monthly control LSM (C-LSM) intervention on a primary composite endpoint of predictors of cardio-metabolic disease (new onset T2DM, hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia (IFG) and markers of cardio-renal disease) in participants aged 5–40 years with risk factors for T2DM.MethodsThis was a randomised controlled trial performed at the National Diabetes Centre, Sri-Lanka. We individually randomised 4672 participants at risk of T2DM, of whom 3539 (mean age 22.5 (range 6–40 years, 48% males) received either trimonthly (P-LSM n = 1726) or 12-monthly (C-LSM n = 1813) peer educator advice aimed at reducing weight, improving diet, reducing psychological stress and increasing physical activity.ResultsDuring a median follow-up of 3 years, the cumulative incidence of the primary endpoint was n = 479 in P-LSM (74 per 1000 person years) vs. 561 in C-LSM (96 per 1000 person years), with an incident rate ratio (IRR) of 0.89 (95% CI 0.83–0.96, P = 0.02). In post hoc analyses, new onset dysglycaemia (T2DM, IFG and IGT), was the major contributor to the composite and was significantly reduced by P-LSM (IRR 0.9, 95% CI 0.83–0.97, P = 0.01). A significant impact of P-LSM on the incidence of the composite endpoint was noted in 1725 participants (P-LSM n = 850, C-LSM n = 875) aged below 18; P-LSM n = 140 (48 per 1000 person years) versus C-LSM n = 174 (55.4 per 1000 person years), with an IRR of 0.83 (95% CI 0.73–0.94, P = 0.004).ConclusionsIn a young at-risk South-Asian population, a pragmatic LSM programme significantly reduces the incidence of predictors of cardio-metabolic disease. Our results highlight the importance of early intervention in young at-risk subjects.Trial registrationWorld Health Organization international clinical trial registry platform (SLCTR/2008/003). Registration Date: March 28, 2008. Retrospectively registered.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-017-0905-6) contains supplementary material, which is available to authorized users.

The Inadequate metabolic and hypertension control, especially in type 2 patients, needs to be addressed.

BackgroundUrban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address the growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate whether intensive (3-monthly) lifestyle modification advice is superior to a less-intensive (12 monthly; control group) lifestyle modification advice on a primary composite cardio-metabolic end point in 'at risk' urban subjects aged between 5-40 years.Methods/DesignThis is an open randomised controlled parallel group clinical trial performed at a single centre in Colombo, Sri-Lanka. A cluster sampling strategy was used to select a large representative sample of subjects aged between 5-40 years at high risk of T2DM and CVD for the intervention study. We have screened 23,298 (males 47% females 53%) healthy subjects for four risk factors: obesity, elevated waist circumference, family history of diabetes and physical inactivity, using a questionnaire and anthropometry. Those with two or more risk-factors were recruited to the intervention trial. We aim to recruit 4600 subjects for the intervention trial. The primary composite cardio-metabolic end point is; new onset T2DM, impaired glucose tolerance, impaired fasting glycaemia, new onset hypertension and albuminuria, following 5 years of intervention. The effect of the intervention on pre-specified secondary endpoints will also be evaluated. The study will be conducted according to good clinical and ethical practice, data analysis and reporting guidelines.DiscussionDIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and cardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on cardio-metabolic disease end points. This work will enable country specific and regional cardio-metabolic risk scores to be derived. Further if the proposed intervention is successful the results of this study can be translated and implemented as a low-cost primary prevention tool in Sri-Lanka and other low/middle income developing countries.Trial registrationThe trial is registered with the World Health Organisation and Sri-Lanka clinical trial registry number SLCTR/2008/003

Background This study evaluated the cost effectiveness of an intensive lifestyle modification (LSM) intervention delivered by peer educators for the prevention of type 2 diabetes mellitus in a young at-risk population in a low healthcare resource setting. Objective The aim of this study was to evaluate the short-term and long-term cost effectiveness of an intensive lifestyle modification intervention for type 2 diabetes prevention in a young urban at-risk population in Sri Lanka. Methods This was an economic evaluation using cost and outcome data from a randomized controlled trial. We randomized 3539 healthy individuals aged 5-40 years with risk factors for type 2 diabetes to either 3-monthly (P-LSM n = 1727) or 12-monthly (C-LSM n = 1812) peer-educator advice aimed at reducing weight, improving diet, reducing psychological stress and increasing physical activity. A cost-effectiveness analysis was conducted from a health system perspective with outcomes expressed as disability-adjusted life-years (DALYs). Intervention costs and outcomes were collected during a median clinical trial period of 3 years and extrapolated to a lifetime horizon using economic modelling. Uncertainty in the lifetime model was explored by structural and probabilistic sensitivity analyses. Results The costs of the more intensive peer support programme were partially offset by reduced costs of type 2 diabetes complications recorded over the trial period and completely offset by lifetime cost savings of 6000 LKR. The more intensive P-LSM also averted more DALYs, estimated at 0.456 DALYs over the lifetime of participants. Conclusions In a young at-risk Sri Lanka population, an intensive LSM programme was cost effective, averting more DALYs at an acceptable additional cost than a much less intensive LSM programme. Early intervention in young at-risk people represents good value for money from the Sri Lankan health care payer perspective.