HbA1c 5.7-6.4% and impaired fasting plasma glucose for diagnosis of prediabetes and risk of progression to diabetes in Japan (TOPICS 3): a longitudinal cohort study
HbA1c 5.7-6.4% and impaired fasting plasma glucose for diagnosis of prediabetes and risk of progression to diabetes in Japan (TOPICS 3): a longitudinal cohort study
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DOI：
10.1016/s0140-6736(11)60472-8
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发表时间：
2011-07-09
期刊：
影响因子：
168.9
通讯作者：
Sone, Hirohito
中科院分区：
文献类型：
--
作者：
Heianza, Yoriko;Hara, Shigeko;Sone, Hirohito
背景 糖尿病前期诊断标准与预测糖尿病进展的临床相关性研究很少。我们的目的是比较通过新的糖化血红蛋白 A(1c) (HbA(1c)) 5.7-6.4% 标准或空腹血糖受损评估时的糖尿病前期患病率，并评估日本人群中这两种糖尿病前期标准之间糖尿病进展率的差异。 方法 我们的纵向队列研究包括 4670 名男性和 1571 名女性 年龄 24-82 岁，基线时无糖尿病（糖尿病的定义为空腹血糖 >= 7.0 mmol/L，自我报告的临床医生诊断为糖尿病，或 HbA(1c) >= 6.5%），1997 年至 2003 年间在虎之门医院（日本东京）进行常规健康检查。根据受损情况基线诊断为糖尿病前期的参与者 根据糖尿病前期的基线诊断，将空腹血糖（空腹血糖5.6-6.9 mmol/L）或HbA(1c) 5.7-6.4%或两者均分为四组。每年评估糖尿病进展率。结果平均随访时间为 4.7 (SD 0.7) 年。根据 HbA(1c) 5.7-6.4% 标准，6241 名参与者中有 412 名 (7%) 被诊断为糖尿病前期。在通过空腹血糖受损和 HbA(1c) 组合诊断的 2092 名糖尿病前期个体中，仅通过 HbA(1c) 筛查漏掉了 1270 名 (61%) 5.7-6.4%。在仅通过 HbA(1c) 或单独空腹血糖受损诊断不一致的糖尿病前期参与者之间，进展为糖尿病的总体累积概率没有显着差异（单独 HbA(1c) [n=412 人和 30 例病例] 的发生率为 7%，单独空腹血糖受损的发生率为 9% [n=1270,108 例]；对数秩检验，p=0.3317）。对于仅通过空腹血糖受损诊断为糖尿病前期的患者，发生糖尿病的多变量调整风险比为 6.16 (95% CI 4.33-8.77)；对于仅通过 HbA(1c) 诊断为糖尿病前期的患者，其发生糖尿病的风险比为 6.00 (3.76-9.56)；对于同时通过空腹血糖受损和 HbA(1c) 诊断为糖尿病前期的患者，该风险比大幅增加至 31.9 (22.6-45.0)。 HbA(1c) 与血糖正常的个体进行比较。解释 通过新的 HbA(1c) 标准和空腹血糖受损对糖尿病前期的诊断可识别出进展为糖尿病的风险增加的个体。尽管与空腹血糖受损相比，新的 HbA(1c) 标准识别出的高危个体较少，但通过 HbA(1c) 5.7-6.4% 评估的进展为糖尿病的预测值与仅通过空腹血糖受损评估的预测值相似。这两种测试一起使用可以有效地针对最有可能患糖尿病的人并进行早期干预。
Background The clinical relevance of the diagnostic criteria for prediabetes to prediction of progression to diabetes has been little studied. We aimed to compare the prevalence of prediabetes when assessed by the new glycated haemoglobin A(1c) (HbA(1c)) 5.7-6.4% criterion or by impaired fasting glucose, and assessed differences in progression rate to diabetes between these two criteria for prediabetes in a Japanese population.Methods Our longitudinal cohort study included 4670 men and 1571 women aged 24-82 years without diabetes at baseline (diabetes was defined as fasting plasma glucose >= 7.0 mmol/L, self-reported clinician-diagnosed diabetes, or HbA(1c) >= 6.5%) who attended Toranomon Hospital (Tokyo, Japan) for a routine health check between 1997 and 2003. Participants with a baseline diagnosis of prediabetes according to impaired fasting glucose (fasting plasma glucose 5.6-6.9 mmol/L) or HbA(1c) 5.7-6.4%, or both, were divided into four groups on the basis of baseline diagnosis of prediabetes. Rate of progression to diabetes was assessed annually.Findings Mean follow-up was 4.7 (SD 0.7) years. 412 (7%) of 6241 participants were diagnosed with prediabetes on the basis of the HbA(1c) 5.7-6.4% criterion. Screening by HbA(1c) alone missed 1270 (61%) of the 2092 prediabetic individuals diagnosed by a combination of impaired fasting glucose and HbA(1c) 5.7-6.4%. Overall cumulative probability of progression to diabetes did not differ significantly between participants with prediabetes discordantly diagnosed by either HbA(1c) or impaired fasting glucose alone (incidence was 7% for HbA(1c) alone [n=412 individuals and 30 incident cases] and 9% for impaired fasting glucose alone [n=1270,108 cases]; log-rank test, p=0.3317). Multivariate-adjusted hazard ratios for incident diabetes were 6.16 (95% CI 4.33-8.77) for those diagnosed with prediabetes by impaired fasting glucose alone and 6.00 (3.76-9.56) for diagnosis by HbA(1c) alone, and were substantially increased to 31.9 (22.6-45.0) for diagnosis by both impaired fasting glucose and HbA(1c) compared with normoglycaemic individuals.Interpretation Diagnosis of prediabetes by both the new HbA(1c) criterion and impaired fasting glucose identified individuals with an increased risk of progression to diabetes. Although the new HbA(1c) criterion identified fewer individuals at high risk than did impaired fasting glucose, the predictive value for progression to diabetes assessed by HbA(1c) 5.7-6.4% was similar to that assessed by impaired fasting glucose alone. The two tests used together could efficiently target people who are most likely to develop diabetes and allow for early intervention.