Background: Urban South-Asianââ?¬â?¢s are predisposed to early onset of type 2 diabetes mellitus (T2DM) and\r\ncardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address\r\nthe growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate\r\nwhether intensive (3-monthly) lifestyle modification advice is superior to a less-intensive (12 monthly; control\r\ngroup) lifestyle modification advice on a primary composite cardio-metabolic end point in ââ?¬Ë?at riskââ?¬â?¢ urban subjects\r\naged between 5-40 years.\r\nMethods/Design: This is an open randomised controlled parallel group clinical trial performed at a single centre in\r\nColombo, Sri-Lanka. A cluster sampling strategy was used to select a large representative sample of subjects aged\r\nbetween 5-40 years at high risk of T2DM and CVD for the intervention study. We have screened 23,298 (males 47%\r\nfemales 53%) healthy subjects for four risk factors: obesity, elevated waist circumference, family history of diabetes\r\nand physical inactivity, using a questionnaire and anthropometry. Those with two or more risk-factors were\r\nrecruited to the intervention trial. We aim to recruit 4600 subjects for the intervention trial. The primary composite\r\ncardio-metabolic end point is; new onset T2DM, impaired glucose tolerance, impaired fasting glycaemia, new onset\r\nhypertension and albuminuria, following 5 years of intervention. The effect of the intervention on pre-specified\r\nsecondary endpoints will also be evaluated. The study will be conducted according to good clinical and ethical\r\npractice, data analysis and reporting guidelines.\r\nDiscussion: DIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and\r\ncardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on\r\ncardio-metabolic disease end points. This work will enable country specific and regional cardio-metabolic risk\r\nscores to be derived. Further if the proposed intervention is successful the results of this study can be translated\r\nand implemented as a low-cost primary prevention tool in Sri-Lanka and other low/middle income developing\r\ncountries.
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