Wijesuriya Mahen, Fountoulakis Nikolaos, Guess Nicola, Banneheka Sarath, Vasantharajah Laksha, Gulliford Martin, Viberti Giancarlo, Gnudi Luigi, Karalliedde Janaka
Diabetes Association of Sri Lanka, Colombo, Sri Lanka.
Cardiovascular Division, Faculty of Life Science & Medicine, King's College London, London, UK.
BMC Med. 2017 Aug 30;15(1):146. doi: 10.1186/s12916-017-0905-6.
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.
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.
During 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).
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.
World Health Organization international clinical trial registry platform ( SLCTR/2008/003 ). Registration Date: March 28, 2008. Retrospectively registered.
南亚城市青年中2型糖尿病（T2DM）的发病率呈上升趋势。我们测试了一项实用的每三个月一次的生活方式改变（LSM）计划（P-LSM）与强度较低的每年一次的对照LSM（C-LSM）干预措施，对年龄在5至40岁、有T2DM风险因素的参与者的心血管代谢疾病预测指标（新发T2DM、高血压、糖耐量受损（IGT）、空腹血糖受损（IFG）和心肾疾病标志物）这一主要复合终点的影响。
这是一项在斯里兰卡国家糖尿病中心进行的随机对照试验。我们将4672名有T2DM风险的参与者进行了个体随机分组，其中3539人（平均年龄22.5岁（范围6至40岁，48%为男性）接受了每三个月一次（P-LSM组n = 1726）或每年一次（C-LSM组n = 1813）的同伴教育建议，旨在减轻体重、改善饮食、减轻心理压力和增加身体活动。
在中位随访3年期间，P-LSM组主要终点的累积发病率为n = 479（每1000人年74例），C-LSM组为561（每1000人年96例），发病率比（IRR）为0.89（95%CI 0.83 - 0.96，P = 0.02）。在事后分析中，新发血糖异常（T2DM、IFG和IGT）是该复合终点的主要因素，P-LSM使其显著降低（IRR 0.9，95%CI 0.83 - 0.97，P = 0.01）。在1725名年龄低于18岁的参与者中（P-LSM组n = 850，C-LSM组n = 875），注意到P-LSM对复合终点发病率有显著影响；P-LSM组为n = 140（每1000人年48例），C-LSM组为n = 174（每1000人年55.4例），IRR为0.83（95%CI 0.73 - 0.94，P = 0.004）。
在年轻的高危南亚人群中，一项实用的LSM计划显著降低了心血管代谢疾病预测指标的发病率。我们的结果突出了对年轻高危受试者进行早期干预的重要性。
世界卫生组织国际临床试验注册平台（SLCTR/2008/003）。注册日期：2008年3月28日。回顾性注册。
