Can earlier biomarker measurements explain a treatment effect on diabetes incidence? A robust comparison of five surrogate markers.
Can earlier biomarker measurements explain a treatment effect on diabetes incidence? A robust comparison of five surrogate markers.
复制标题
DOI：
10.1136/bmjdrc-2023-003585
复制
发表时间：
2023-10
影响因子：
4.1
通讯作者：
Palaniappan LP
中科院分区：
文献类型：
--
作者：
Parast L;Tian L;Cai T;Palaniappan LP
我们测量并比较了5个单独的替代标志物--血红蛋白A1 c（HbA 1c）、空腹血糖、攻毒后2小时血糖、空腹血糖指数（TyG）指数和胰岛素抵抗稳态模型评估（HOMA-IR）从基线到随机化后1年的变化--在解释治疗对降低2型糖尿病风险的作用方面的能力，治疗开始后4年。研究参与者来自糖尿病预防计划研究，随机分配到生活方式干预组（n=1023）或安慰剂组（n=1030）。在基线和1年时测量替代标志物，并在随机化后2、3和4年检查糖尿病发病率。使用替代标志物解释的治疗效应比例（PTE）的稳健无模型估计值评价替代性。在所有时间点，空腹血糖和HOMA-IR的变化解释的治疗效应比例高于2小时血糖、TyG指数或HbA 1c。例如，在2年时，葡萄糖解释了治疗效果的最高比例（80.1%），其次是HOMA-IR（77.7%）、2小时葡萄糖（76.2%）和HbA 1c（74.6%）; TyG指数解释了最小比例（70.3%）。这些数据表明，在检查的5种替代标志物中，葡萄糖和HOMA-IR是PTE方面的上级替代标志物，与2小时葡萄糖、HbA 1c和TyG指数相比。
We measured and compared five individual surrogate markers—change from baseline to 1 year after randomization in hemoglobin A1c (HbA1c), fasting glucose, 2-hour postchallenge glucose, triglyceride–glucose index (TyG) index, and homeostatic model assessment of insulin resistance (HOMA-IR)—in terms of their ability to explain a treatment effect on reducing the risk of type 2 diabetes mellitus at 2, 3, and 4 years after treatment initiation. Study participants were from the Diabetes Prevention Program study, randomly assigned to either a lifestyle intervention (n=1023) or placebo (n=1030). The surrogate markers were measured at baseline and 1 year, and diabetes incidence was examined at 2, 3, and 4 years postrandomization. Surrogacy was evaluated using a robust model-free estimate of the proportion of treatment effect explained (PTE) by the surrogate marker. Across all time points, change in fasting glucose and HOMA-IR explained higher proportions of the treatment effect than 2-hour glucose, TyG index, or HbA1c. For example, at 2 years, glucose explained the highest (80.1%) proportion of the treatment effect, followed by HOMA-IR (77.7%), 2-hour glucose (76.2%), and HbA1c (74.6%); the TyG index explained the smallest (70.3%) proportion. These data suggest that, of the five examined surrogate markers, glucose and HOMA-IR were the superior surrogate markers in terms of PTE, compared with 2-hour glucose, HbA1c, and TyG index.
登录
查看更多内容
影响因子：
158.5
作者：
Knowler, WC;Barrett-Connor, E;Nathan, DM
通讯作者：
Nathan, DM
影响因子：
1.9
作者：
Parast, Layla;Cai, Tianxi;Tian, Lu
通讯作者：
Tian, Lu
影响因子：
1.9
作者：
Frangakis, CE;Rubin, DB
通讯作者：
Rubin, DB
影响因子：
3.7
作者：
KAPLAN, EL;MEIER, P
通讯作者：
MEIER, P
影响因子：
2
作者：
Parast L;McDermott MM;Tian L
通讯作者：
Tian L