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Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities: The FOCUS Randomized Clinical Trial

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机构: [1]China Acad Chinese Med Sci, Good Clin Practice Off, Guanganmen Hosp, Beijing, Peoples R China [2]China Acad Chinese Med Sci, Dept Endocrinol, Guanganmen Hosp, Beijing, Peoples R China [3]Guangdong Prov Hosp Tradit Chinese Med, Dept Prevent & Treatment Dis, Guangzhou, Peoples R China [4]Tangshan Gongren Hosp, Dept Endocrinol, Tangshan, Peoples R China [5]Hebei Yiling Hosp, Dept Endocrinol, Shijiazhuang, Peoples R China [6]Shijiazhuang 2nd Hosp, Dept Tradit Chinese Med, Shijiazhuang, Peoples R China [7]Baotou Cent Hosp, Dept Gen Surg, Baotou, Peoples R China [8]Harbin Med Univ, Affiliated Hosp 1, Dept Endocrinol, Harbin, Peoples R China [9]Shihezi Univ, Affiliated Hosp 1, Dept Tradit Chinese Med, Med Coll, Shihezi, Peoples R China [10]Heilongjiang Acad Tradit Chinese Med, Dept Gastroenterol, Harbin, Peoples R China [11]Shaanxi Univ Tradit Chinese Med, Affiliated Hosp, Dept Endocrinol, Xianyang, Peoples R China [12]Futian Guangzhou Univ Chinese Med, Shenzhen Hosp, Dept Endocrinol, Shenzhen, Peoples R China [13]Tongliao City Horqin Dist First Peoples Hosp, Dept Endocrinol, Tongliao, Peoples R China [14]Baoji Second Peoples Hosp, Dept Endocrinol, Baoji, Peoples R China [15]Hebei Cangzhou Hosp Integrated Chinese & Western M, Dept Endocrinol, Cangzhou, Peoples R China [16]Nanjing Drum Tower Hosp, Dept Tradit Chinese Med, Nanjing, Peoples R China [17]Liaocheng Peoples Hosp, Geriatr Dept, Liaocheng, Peoples R China [18]Yunnan Univ Chinese Med, Dept Endocrinol, Affiliated Hosp 2, Kunming, Peoples R China [19]Guangdong Pharmaceut Univ, Dept Endocrinol, Affiliated Hosp 1, Guangzhou, Peoples R China [20]Peking Univ First Hosp, Dept Biostat, Beijing, Peoples R China [21]Hebei Gen Hosp, Dept Endocrinol, Shijiazhuang, Peoples R China [22]Tianjin Med Univ, Chu Hsien I Mem Hosp, NHC Key Lab Hormones & Dev, Tianjin, Peoples R China [23]Tianjin Med Univ, Tianjin Inst Endocrinol, Tianjin, Peoples R China [24]Shanghai Univ Tradit Chinese Med, Ctr Drug Clin Res, Shanghai, Peoples R China [25]Peking Union Med Coll Hosp, Dept Endocrinol, Beijing, Peoples R China [26]Sun Yat sen Univ, Sun Yat sen Mem Hosp, Dept Endocrinol, Guangzhou, Peoples R China [27]China Acad Chinese Med Sci, Guanganmen Hosp, Inst Metab Dis, Beijing, Peoples R China [28]Hebei Yiling Hosp, State Key Lab Innovat & Transformat Luobing Theory, Shijiazhuang 050091, Hebei, Peoples R China [29]China Acad Chinese Med Sci, Guanganmen Hosp, Beijing 100053, Peoples R China
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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 (HbA(1c)), 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; HbA(1c); 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 participants were randomized, of whom 885 were in the full analysis set (442 in the JLD group; 443 in the placebo group; mean [SD] age, 52.57 [10.33] years; 463 [52.32%] female). Following a median observation period of 2.20 years (IQR, 1.27-2.64 years), participants in the JLD group had a lower risk of developing diabetes compared with those in the placebo group (hazard ratio, 0.59; 95% CI, 0.46-0.74; P < .001). During the follow-up period, the JLD group had a between-group difference of 0.95 cm (95% CI, 0.36-1.55 cm) in waist circumference, 9.2 mg/dL (95% CI, 5.4-13.0 mg/dL) in 2-hour postprandial blood glucose level, 3.8 mg/dL (95% CI, 2.2-5.6 mg/dL) in fasting blood glucose level, 0.20% (95% CI, 0.13%-0.27%) in HbA(1c), 6.6 mg/dL (95% CI, 1.9-11.2) in total cholesterol level, 4.3 mg/dL (95% CI, 0.8-7.7 mg/dL) in low-density lipoprotein cholesterol level, 25.7 mg/dL (95% CI, 15.9-35.4 mg/dL) in triglyceride levels, and 0.47 (95% CI, 0.12-0.83) in HOMA-IR compared with the placebo group. After 24 months of follow-up, the JLD group had a significant improvement in ankle-brachial index and waist circumference compared with the placebo group. Conclusions and Relevance The findings suggest that JLD can reduce the risk of diabetes in participants with IGT and multiple metabolic abnormalities.

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大类 | 1 区 医学
小类 | 1 区 医学:内科
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Q1 MEDICINE, GENERAL & INTERNAL
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]China Acad Chinese Med Sci, Good Clin Practice Off, Guanganmen Hosp, Beijing, Peoples R China
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通讯机构: [1]China Acad Chinese Med Sci, Good Clin Practice Off, Guanganmen Hosp, Beijing, Peoples R China [5]Hebei Yiling Hosp, Dept Endocrinol, Shijiazhuang, Peoples R China [27]China Acad Chinese Med Sci, Guanganmen Hosp, Inst Metab Dis, Beijing, Peoples R China [28]Hebei Yiling Hosp, State Key Lab Innovat & Transformat Luobing Theory, Shijiazhuang 050091, Hebei, Peoples R China [29]China Acad Chinese Med Sci, Guanganmen Hosp, Beijing 100053, Peoples R China [*1]State Key Laboratory for Innovation and Transformation of Luobing Theory of Hebei Yiling Hospital, Shijiazhuang, 050091, Hebei Province, China [*2]Guang’anmen Hospital China Academy of Chinese Medical Sciences, Beijing 100053, China.
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