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Background: There 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. Methods: This 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. Results: During a median follow-up of 3years, 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). Conclusions: In 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 registration: World Health Organization international clinical trial registry platform ( SLCTR/2008/003 ). Registration Date: March 28, 2008. Retrospectively registered.
Wijesuriya, M., Fountoulakis, N., Guess, N., Banneheka, S., Vasantharajah, L., Gulliford, M., … Karalliedde, J. (2017). A pragmatic lifestyle modification programme reduces the incidence of predictors of cardio-metabolic disease and dysglycaemia in a young healthy urban South Asian population: A randomised controlled trial. BMC Medicine, 15(1). https://doi.org/10.1186/s12916-017-0905-6