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

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

Improvements in stage of change correlate to changes in dietary intake and clinical outcomes in a 5-year lifestyle intervention in young high-risk Sri Lankans

“…The design of the trial is described in full elsewhere. 23 In brief, 4683 Sri Lankan urban young males and females aged 5-40 years at high risk of metabolic syndrome were randomized to intensive lifestyle modification group or less intensive control group. The principles of the lifestyle change program, which included changes in diet and physical activity, were based upon the Indian Diabetes Prevention Program (IDPP).…”

“…Participants were recruited from schools and work places to include a range of educational levels including no formal education, <5 years formal education, secondary education, pre-university and higher education. 23 Following screening of 23,298 participants, 5164 were identified as being eligible for the trial of whom 4682 participants attended the baseline screening. As this study assesses the TTM of behaviour change which has not been well validated in those under 11 14 this study examines the data of all individuals over the age of 10 years at study recruitment (n=2637).…”

International Models of Care that Address the Growing Diabetes Prevalence in Developing Countries

“…To date, the vast majority of prevention efforts have targeted adults at high-risk for developing diabetes, but this conventional approach may not be sufficient for slowing the diabetes epidemic, particularly in populations (e.g., South Asians) which display a rapid conversion from prediabetes to diabetes [29]. For example, the DIABRISK-SL [55] RCT in Sri Lanka aims to compare an intensive (3 months) lifestyle modification advice to a less-intensive (12 monthly; control group) lifestyle modification advice on a primary composite cardio-metabolic endpoint, in at-risk (two or more of the following: obesity, elevated waist circumference, family history of diabetes, or physically inactive) urban subjects aged between 5 and 40 years. Early results indicate a 26 % (95 % CI 7-28 %) relative risk reduction in diabetes incidence among participants in the intensive lifestyle intervention compared to the lessintensive intervention [56].…”

Модифікація Способу Життя Та Дієтичне Харчування Хворих На Артеріальну Гіпертензію У поєднанні З Цукровим Діабетом: Рекомендації Європейських Консенсусів Та Реалії Життя (Огляд Літератури)

“…Останнім десятиліттям проведе-но низку епідеміологічних досліджень щодо ролі здо-рового харчування й окремих нутрієнтів із первин-ної профілактики при АГ, АО, ЦД 2-го типу (OMNI HEART study, Mediterranean Diet, MUFA diet study, ATTICA registry, EPIC, SUN, PREvencion con DIeta MEDiterranea, PREDIMED study). Відомі також до-слідження щодо профілактики та сприятливих ефек-тів антигіпертензивних, антидіабетичних і анорекси-генних препаратів (KOPS, EPIC, STORM, XENDOS, RIO-EUROPA, RIO-DIABETES, [30][31][32][33][34][35][36][37][38][39][40][41].…”

“…Наприкінці минулого сторіччя отримано дані щодо впливу окремих нутрієнтів на рівні АТ та глі-кемії [30][31][32][33][34][35][36][37][38][39][40][41][42][68][69][70][71][72][73].Серед продуктів харчування, що містять речовини й компоненти, які поліпшують функцію ендотелію, слід назвати антоціаніни, фла-воноїдні полімери, флавоноли, ізофлавони, полі-феноли, станоли, фолієву кислоту, антиоксиданти, лютеїн, резвератрол. Метааналіз 36 досліджень із се-редньодобовим споживанням 3,7 г риб'ячого жиру демонструє вірогідне зниження АТ на 2,1/1,6 мм рт.ст.…”