JAMA. 2003 Oct 22;290(16):2159-67. doi: 10.1001/jama.290.16.2159.
The Diabetes Control and Complications Trial (DCCT) demonstrated the benefits of intensive treatment of diabetes in reducing glycemic levels and slowing the progression of diabetic nephropathy. The DCCT cohort has been examined annually for another 8 years as part of the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study. During the EDIC study, glycemic levels no longer differed substantially between the 2 original treatment groups.
To determine the long-term effects of intensive vs conventional diabetes treatment during the DCCT on kidney function during the EDIC study.
DESIGN, SETTING, AND PARTICIPANTS: Observational study begun in 1993 (following DCCT closeout) in 28 medical centers in the United States and Canada. Participants were 1349 (of 1375) EDIC volunteers who had kidney evaluation at years 7 or 8.
Development of microalbuminuria, clinical-grade albuminuria, hypertension, or increase in serum creatinine level.
Results were analyzed by intention-to-treat analyses, comparing the 2 original DCCT treatment groups. New cases of microalbuminuria occurred during the EDIC study in 39 (6.8%) of the participants originally assigned to the intensive-treatment group vs 87 (15.8%) of those assigned to the conventional-treatment group, for a 59% (95% confidence interval [CI], 39%-73%) reduction in odds, adjusted for baseline values, compared with a 59% (95% CI, 36%-74%) reduction at the end of the DCCT (P<.001 for both comparisons). New cases of clinical albuminuria occurred in 9 (1.4%) of the participants in the original intensive-treatment group vs 59 (9.4%) of those in the original conventional-treatment group, representing an 84% reduction in odds (95% CI, 67%-92%), compared with a reduction of 57% (95% CI, -1% to +81%) at the end of the DCCT. Fewer cases of hypertension (prevalence at year 8, 29.9% vs 40.3%; P<.001) developed in the original intensive-treatment group. Significantly fewer participants reached a serum creatinine level of 2 mg/dL or greater in the intensive-treatment vs the conventional-treatment group (5 vs 19, P =.004), but there were no differences in mean log clearance values. Although small numbers of patients required dialysis and/or transplantation, fewer patients experienced either of these outcomes in the intensive group (4 vs 7, P =.36).
The persistent beneficial effects on albumin excretion and the reduced incidence of hypertension 7 to 8 years after the end of the DCCT suggest that previous intensive treatment of diabetes with near-normal glycemia during the DCCT has an extended benefit in delaying progression of diabetic nephropathy.
糖尿病控制与并发症试验（DCCT）证明了强化治疗糖尿病在降低血糖水平和减缓糖尿病肾病进展方面的益处。作为后续糖尿病干预与并发症流行病学（EDIC）研究的一部分，DCCT队列又接受了8年的年度检查。在EDIC研究期间，两个最初的治疗组之间血糖水平不再有显著差异。
确定DCCT期间强化与常规糖尿病治疗对EDIC研究期间肾功能的长期影响。
设计、地点和参与者：1993年（DCCT结束后）在美国和加拿大的28个医疗中心开展的观察性研究。参与者为1375名EDIC志愿者中的1349名，他们在第7年或第8年接受了肾脏评估。
微量白蛋白尿、临床级白蛋白尿、高血压的发生情况或血清肌酐水平升高。
采用意向性分析对结果进行分析，比较两个最初的DCCT治疗组。在EDIC研究期间，最初分配至强化治疗组的参与者中有39名（6.8%）出现微量白蛋白尿新病例，而分配至常规治疗组的参与者中有87名（15.8%）出现，经基线值调整后，优势比降低59%（95%置信区间[CI]，39%-73%），与DCCT结束时降低59%（95%CI，36%-74%）相比（两项比较P均<0.001）。最初强化治疗组的参与者中有9名（1.4%）出现临床白蛋白尿新病例，而最初常规治疗组的参与者中有59名（9.4%）出现，优势比降低84%（95%CI，67%-92%），与DCCT结束时降低57%（95%CI，-1%至+81%）相比。最初强化治疗组发生高血压的病例较少（第8年患病率，29.9%对40.3%；P<0.001）。强化治疗组达到血清肌酐水平2mg/dL或更高的参与者明显少于常规治疗组（5名对19名；P=0.004），但平均对数清除率值无差异。虽然少数患者需要透析和/或移植，但强化治疗组经历这些结局的患者较少（4名对7名；P=0.36）。
DCCT结束7至8年后对白蛋白排泄的持续有益影响以及高血压发病率的降低表明，DCCT期间先前对糖尿病进行的接近正常血糖的强化治疗在延缓糖尿病肾病进展方面具有长期益处。
