title: DIABRISK-SL prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's--study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Urban 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
  This 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.
  
  
  CONCLUSIONS
  DIABRISK-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.
  
  
  BACKGROUND
  The trial is registered with the World Health Organisation and Sri-Lanka clinical trial registry number SLCTR/2008/003.
authors.affiliation: Diabetes Association of Sri Lanka, National Diabetes Centre, Colombo, Sri Lanka.
authors.forename: Mahen
authors.initials: M
authors.lastname: Wijesuriya
authors.forename: Martin
authors.initials: M
authors.lastname: Gulliford
authors.forename: Laksha
authors.initials: L
authors.lastname: Vasantharajah
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Viberti
authors.forename: Luigi
authors.initials: L
authors.lastname: Gnudi
authors.forename: Janaka
authors.initials: J
authors.lastname: Karalliedde
mesh_terms: D000293:Adolescent; D000328:Adult; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D012107:Research Design; D013188:Sri Lanka