Lauritzen T, Griffin S, Borch-Johnsen K, Wareham N J, Wolffenbuttel B H, Rutten G
Department of General Practice, University of Aarhus, Denmark.
Int J Obes Relat Metab Disord. 2000 Sep;24 Suppl 3:S6-11. doi: 10.1038/sj.ijo.0801420.
The overall aims of the ADDITION study are to evaluate whether screening for prevalent undiagnosed Type 2 diabetes is feasible, and whether subsequent optimised intensive treatment of diabetes, and associated risk factors, is feasible and beneficial.
Population-based screening in three European countries followed by an open, randomised controlled trial.
People aged 40-69 y in the community, without known diabetes, will be offered a random capillary blood glucose screening test by their primary care physicians, followed, if equal to or greater than 5.5 mmol/l, by fasting and 2-h post-glucose-challenge blood glucose measurements. Three thousand newly diagnosed patients will subsequently receive conventional treatment (according to current national guidelines) or intensive multifactorial treatment (lifestyle advice, prescription of aspirin and ACE-inhibitors, in addition to protocol-driven tight control of blood glucose, blood pressure and cholesterol). Patients allocated to intensive treatment will be further randomised to centre-specific interventions to motivate adherence to lifestyle changes and medication. Duration of follow-up is planned for 5 y. Endpoints will include mortality, macrovascular and microvascular complications, patient health status and satisfaction, process-of-care indicators and costs.
ADDITION研究的总体目标是评估对未确诊的2型糖尿病进行筛查是否可行,以及随后对糖尿病及相关危险因素进行优化强化治疗是否可行且有益。
在三个欧洲国家进行基于人群的筛查,随后进行开放、随机对照试验。
社区中年龄在40 - 69岁、无已知糖尿病的人群将由其初级保健医生提供随机毛细血管血糖筛查检测,若血糖等于或高于5.5 mmol/l,则进一步进行空腹及葡萄糖耐量试验后2小时血糖测量。随后,3000名新确诊的患者将接受常规治疗(根据当前国家指南)或强化多因素治疗(生活方式建议、阿司匹林和血管紧张素转换酶抑制剂处方,以及按照方案严格控制血糖、血压和胆固醇)。分配到强化治疗组的患者将进一步随机接受特定中心的干预措施,以促使其坚持生活方式改变和药物治疗。计划随访期为5年。终点指标将包括死亡率、大血管和微血管并发症、患者健康状况和满意度、医疗过程指标及成本。