Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities

作者：Hangyu Ji, Xuefei Zhao, Xinyan Chen, Hui Fang, Huailin Gao, Geng Wei, Min Zhang, Hongyu Kuang, Baijing Yang, Xiaojun Cai, Yanjin Su, Chunli Piao, Shuyu Zhao, Liyang Li, Wenliang Sun, Tianshu Xu, Qing‐Hua Xu, Fan Yuan, Jianhua Ye, Chen Yao, Meixia Shang, Guangyao Song, Liming Chen, Qingshan Zheng, Xinhua Xiao, Yan Li, Fengmei Lian, Xiaolin Tong, Zhenhua Jia, Liying Lun, Sulin Hu, Haipeng Liu, Guangyu Cai, Huan Li, Ling Huang, Mengling Tian, Jiale Wan, Peizhen Song, Yaqin Zhang, Fan Li, Xiaoyan Hu, Jing Xu, Ying Pang, Jing Shi, Hongwei Cheng, Wenhong Tian, Huiling Wang, Gangxin Qin, Qiuju Zhao, Lulu Wang, Junting Luo, Luyv Liu, Li Zhao, Wenjiao Xie, Xinlun Cai, Gaohong Qiao, Aoran Song, Jianxiu Li, Wendan Zhang, Qiong Wu, Yanan Wang, Qijun Fang, Lijun Yue, Yuling Zhang, Hu Li, You Qin, Li Wang, Siyu Zhao, Liwei Zhang, Hui Guo, Lina Dai, Wenjuan Niu, Wei Gao, Minzhou Li, Ruixia Zhang, Yixuan Liu, Jingwen Wang, Congchao Zhang, Siyuan Li, Yurong Feng, Yingran Dai, Ren Sa, Lili Sang, Haiyan Wang, Weiwei Yin, Hong Zhang, Fengjun Sun, Li Ma, Junyong Yang, Xuanmin Zhang, Xia Gan, Sheng Yang, Yun Zhou, Junhu Lu, Tong Xu, Haoran Li, Zhen Li, Xiaoxia Pan, Li Zhang, Jialin Han, Acui Yu, Jingqing Jing, Li Huang, Xi Chen, Xuling Wang, Jilai Shi, Bingyan Wang, Guanghui Sun, Kaimin Li, Tingting Zhou, Mengying Shi, Hongli Liu, Xueling Sun, Hewei Zhang, Wenhui Hong, Nan Huang, Xiufen Chen, Jinxiang Zheng, Yongjuan Juan, Rongrong Zhou, Huidan Wang, Chunxue Zang, Yi‐Wen Lai, Zedong Peng, Ruyu Chen, Xinhui Liu, Mengjie Cai, Xu Han · 发表于：JAMA Internal Medicine · 年份：2024 · DOI：10.1001/jamainternmed.2024.1190 · 被引用次数：33 · 研究领域：Diabetes, Cardiovascular Risks, and Lipoproteins、Diabetes Treatment and Management、Diabetic Foot Ulcer Assessment and Management

Importance: Previous studies have shown that Jinlida (JLD) granules, an approved treatment for type 2 diabetes in China, can reduce blood glucose level, reduce glycated hemoglobin (HbA1c), and improve insulin resistance in people with type 2 diabetes. Objective: To evaluate the effect of long-term administration of JLD vs placebo on the incidence of diabetes in participants with impaired glucose tolerance (IGT) and multiple metabolic abnormalities. Design, Setting, and Participants: This multicenter, double-blind, placebo-controlled randomized clinical trial (FOCUS) was conducted across 35 centers in 21 cities in China from June 2019 to February 2023. Individuals aged 18 to 70 years with IGT and multiple metabolic abnormalities were enrolled. Intervention: Participants were randomly allocated 1:1 to receive JLD or placebo (9 g, 3 times per day, orally). They continued this regimen until they developed diabetes, withdrew from the study, were lost to follow-up, or died. Main Outcomes and Measures: The primary outcome was the occurrence of diabetes, which was determined by 2 consecutive oral glucose tolerance tests. Secondary outcomes included waist circumference; fasting and 2-hour postprandial plasma glucose levels; HbA1c; fasting insulin level; homeostatic model assessment for insulin resistance (HOMA-IR); total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels; ankle-brachial index; and carotid intima-media thickness. Results: A total of 889 participa...