دورية أكاديمية
Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities: The FOCUS Randomized Clinical Trial.
| العنوان: | Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities: The FOCUS Randomized Clinical Trial. |
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| المؤلفون: | Ji H; Good Clinical Practice Office, Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China., Zhao X; Department of Endocrinology, Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China., Chen X; Department of Prevention and Treatment of Disease, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China., Fang H; Department of Endocrinology, Tangshan Gongren Hospital, Tangshan, China., Gao H; Department of Endocrinology, Hebei Yiling Hospital, Shijiazhuang, China., Wei G; Department of Traditional Chinese Medicine, Shijiazhuang 2nd Hospital, Shijiazhuang, China., Zhang M; Department of General Practice, Baotou Central Hospital, Baotou, China., Kuang H; Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China., Yang B; Department of Traditional Chinese Medicine, The First Affiliated Hospital of Medical College of Shihezi University, Shihezi, China., Cai X; Department of Endocrinology, Heilongjiang Academy of Traditional Chinese Medicine, Harbin, China., Su Y; Department of Endocrinology, Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Xianyang, China., Piao C; Department of Endocrinology, Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine, Shenzhen, China., Zhao S; Department of Endocrinology, Tongliao City Horqin District First People's Hospital, Tongliao, China., Li L; Department of Endocrinology, Baoji Second People's Hospital, Baoji, China., Sun W; Department of Endocrinology, Hebei Cangzhou Hospital of Integrated Chinese and Western Medicine, Cangzhou, China., Xu T; Department of Traditional Chinese Medicine, Nanjing Drum Tower Hospital, Nanjing, China., Xu Q; Geriatrics Department, Liaocheng People's Hospital, Liaocheng, China., Fan Y; Department of Endocrinology, Second Affiliated Hospital of Yunnan University of Chinese Medicine, Kunming, China., Ye J; Department of Endocrinology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China., Yao C; Department of Biostatistics, Peking University First Hospital, Beijing, China., Shang M; Department of Biostatistics, Peking University First Hospital, Beijing, China., Song G; Department of Endocrinology, Hebei General Hospital, Shijiazhuang, China., Chen L; NHC Key Laboratory of Hormones and Development, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China., Zheng Q; Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China., Xiao X; Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China., Yan L; Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yai-Sen University, Guangzhou, China., Lian F; Good Clinical Practice Office, Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China., Tong X; Metabolic Disease Institute, Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China., Jia Z; Department of Endocrinology, Hebei Yiling Hospital, Shijiazhuang, China.; State Key Laboratory for Innovation and Transformation of Luobing Theory of Hebei Yiling Hospital, Shijiazhuang, Hebei Province, China. |
| مؤلفون مشاركون: | FOCUS Trial Committees and Investigators |
| المصدر: | JAMA internal medicine [JAMA Intern Med] 2024 Jul 01; Vol. 184 (7), pp. 727-735. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Multicenter Study; Comment |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 101589534 Publication Model: Print Cited Medium: Internet ISSN: 2168-6114 (Electronic) Linking ISSN: 21686106 NLM ISO Abbreviation: JAMA Intern Med Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago, IL : American Medical Association, [2013]- |
| مواضيع طبية MeSH: | Diabetes Mellitus, Type 2*/blood , Diabetes Mellitus, Type 2*/complications , Glucose Intolerance* , Drugs, Chinese Herbal*/therapeutic use, Humans ; Middle Aged ; Female ; Male ; Double-Blind Method ; Adult ; Blood Glucose/metabolism ; Aged ; China/epidemiology ; Glycated Hemoglobin/metabolism ; Glycated Hemoglobin/analysis ; Insulin Resistance ; Glucose Tolerance Test |
| مستخلص: | 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 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 HbA1c, 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. Trial Registration: Chinese Clinical Trial Register: ChiCTR1900023241. |
| التعليقات: | Comment on: JAMA Intern Med. 2024 Jul 1;184(7):736. doi: 10.1001/jamainternmed.2024.1208. (PMID: 38829623) Erratum in: JAMA Intern Med. 2024 Jul 8. doi: 10.1001/jamainternmed.2024.3409. (PMID: 38976281) |
| فهرسة مساهمة: | Investigator: L Lun; S Hu; H Liu; G Cai; H Li; L Huang; M Tian; J Wan; P Song; Y Zhang; F Li; X Hu; J Xu; Y Pang; J Shi; H Cheng; W Tian; H Wang; G Qin; Q Zhao; L Wang; J Luo; L Liu; L Zhao; W Xie; X Cai; G Qiao; A Song; J Li; W Zhang; Q Wu; Y Wang; Q Fang; L Yue; Y Zhang; L Hu; Q You; L Wang; S Zhao; L Zhang; H Guo; L Dai; W Niu; W Gao; M Li; R Zhang; Y Liu; J Wang; C Zhang; S Li; Y Feng; Y Dai; R Sa; L Sang; H Wang; W Yin; H Zhang; F Sun; L Ma; J Yang; X Zhang; X Gan; Y Sheng; Y Zhou; J Lu; T Xu; H Li; Z Li; X Pan; L Zhang; J Han; A Yu; J Jing; L Huang; X Chen; X Wang; J Shi; B Wang; G Sun; K Li; T Zhou; M Shi; H Liu; X Sun; H Zhang; W Hong; N Huang; X Chen; J Zheng; Y Juan; R Zhou; H Wang; C Zang; Y Lai; Z Peng; R Chen; X Liu; M Cai; X Han |
| المشرفين على المادة: | 0 (jinlida) 0 (Drugs, Chinese Herbal) 0 (Blood Glucose) 0 (Glycated Hemoglobin) |
| تواريخ الأحداث: | Date Created: 20240603 Date Completed: 20240701 Latest Revision: 20240708 |
| رمز التحديث: | 20240708 |
| مُعرف محوري في PubMed: | PMC11148787 |
| DOI: | 10.1001/jamainternmed.2024.1190 |
| PMID: | 38829648 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2168-6114 |
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| DOI: | 10.1001/jamainternmed.2024.1190 |