Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2
Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2
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DOI：
10.1186/1471-2350-14-25
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发表时间：
2013-02-14
影响因子：
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通讯作者：
Boeger, Carsten A.
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文献类型：
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作者：
Doerhoefer, Lena;Lammert, Alexander;Boeger, Carsten A.
背景：2型糖尿病(DM2)与慢性肾脏病(CKD)、终末期肾病(ESRD)和心血管疾病的风险增加密切相关。流行病学和遗传学研究通过揭示糖尿病并发症的新机制，为DM2管理的创新策略提供了假设，这对未来的干预试验至关重要。因此，我们发起了糖尿病队列研究(DIACORE)。方法：DIACORE是一项前瞻性队列研究，旨在招募6000名自称患有DM2的高加索人种患者，并进行至少10年的随访。研究访问是在德国的大学招聘诊所使用标准操作程序进行的。招募中心周围门诊的所有流行的DM2患者都被邀请参加。在基线和每次两年的随访检查中，患者都要接受核心表型分析。这包括标准化的在线问卷和体检，以确定发生的微血管和大血管DM2并发症、恶性肿瘤和住院，主要侧重于肾脏事件。需要从患者记录中获得确认性结果信息。血液样本被用于集中分析的标准实验室小组，并用于为将来的科学使用而对等量的血清、血浆、尿液、mRNA和DNA进行生物库。队列中的一个子集进行了扩展的表型分析，例如睡眠呼吸暂停筛查、皮肤自发荧光测量、非散瞳视网膜照相和动脉硬化的非侵入性测定。讨论：DIACORE将使在生物样本和遗传流行病学研究中使用高通量技术对DM2并发症发病机制所涉及的因素进行前瞻性评估。
Background: Diabetes mellitus type 2 (DM2) is highly associated with increased risk for chronic kidney disease (CKD), end stage renal disease (ESRD) and cardiovascular morbidity. Epidemiological and genetic studies generate hypotheses for innovative strategies in DM2 management by unravelling novel mechanisms of diabetes complications, which is essential for future intervention trials. We have thus initiated the DIAbetes COhoRtE study (DIACORE).Methods: DIACORE is a prospective cohort study aiming to recruit 6000 patients of self-reported Caucasian ethnicity with prevalent DM2 for at least 10 years of follow-up. Study visits are performed in University-based recruiting clinics in Germany using standard operating procedures. All prevalent DM2 patients in outpatient clinics surrounding the recruiting centers are invited to participate. At baseline and at each 2-year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized online questionnaire and physical examination to determine incident micro-and macrovascular DM2 complications, malignancy and hospitalization, with a primary focus on renal events. Confirmatory outcome information is requested from patient records. Blood samples are obtained for a centrally analyzed standard laboratory panel and for biobanking of aliquots of serum, plasma, urine, mRNA and DNA for future scientific use. A subset of the cohort is subjected to extended phenotyping, e. g. sleep apnea screening, skin autofluorescence measurement, non-mydriatic retinal photography and non-invasive determination of arterial stiffness.Discussion: DIACORE will enable the prospective evaluation of factors involved in DM2 complication pathogenesis using high-throughput technologies in biosamples and genetic epidemiological studies.