PMID- 38027146 OWN - NLM STAT- MEDLINE DCOM- 20231222 LR - 20240229 IS - 1664-2392 (Print) IS - 1664-2392 (Electronic) IS - 1664-2392 (Linking) VI - 14 DP - 2023 TI - Effects of mulberry twig alkaloids(Sangzhi alkaloids) and metformin on blood glucose fluctuations in combination with premixed insulin-treated patients with type 2 diabetes. PG - 1272112 LID - 10.3389/fendo.2023.1272112 [doi] LID - 1272112 AB - INTRODUCTION: We aimed to evaluated the effect of premixed insulin (Ins), premixed insulin combined with metformin (Ins+Met) or mulberry twig alkaloids(Ins+SZ-A) on blood glucose fluctuations in patients with type 2 diabetes (T2DM) using continuous glucose monitors (CGM). METHODS: Thirty patients with T2DM and poor blood glucose control using drugs were evaluated for eligibility during the screening period. Subsequently, their original hypoglycemic drugs were discontinued during the lead-in period, and after receiving Ins intensive treatment for 2 weeks, they were randomly assigned to receive either Ins, Ins+Met, or Ins+SZ-A treatment for the following 12 weeks. The main efficacy endpoint comprised changes in their CGM indicators changes (mean blood glucose level [MBG], standard deviation of blood glucose [SDBG], mean amplitude of glycemic excursions [MAGE], postprandial glucose excursions [PPGE], the largest amplitude of glycemic excursions [LAGE], mean of daily difference [MODD], time in range between 3.9-10.0 mmol/L [TIR] and area under the curve for each meal [AUCpp]) during the screening, lead-in, and after 12-week treatment period. Changes in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), 1-h postprandial blood glucose (1h-PBG), 2-h postprandial blood glucose (2h-PBG), fasting blood lipids and postprandial blood lipids were also measured at baseline and after 12 weeks of treatment. RESULTS: The CGM indicators of the three groups during the lead-in period all showed significant improvements compared to the screening period (P<0.05). Compared with those in the lead-in period, all of the CGM indicators improved in the the Ins+Met and Ins+SZ-A groups after 12 weeks of treatment (P<0.05), except for MODD. After 12-week treatment, compared with the Ins group, Ins+Met and Ins+SZ-A groups showed improved MBG, SDBG, TIR, breakfast AUCpp,lunch AUCpp, HbA1c, FBG, 1h-PBG, fasting blood lipid and postprandial blood lipid indicators (P<0.05). Further, the LAGE, PPGE, MAGE, dinner AUCpp and 2h-PBG levels of the Ins+SZ-A group were significantly lower than those of the Ins+Met and Ins groups (P<0.05). CONCLUSION: Our findings highlight the efficacy of combination therapy (Ins+SZ-A or Ins+Met) in improving blood glucose fluctuations, as well as blood glucose and lipid levels. Ins+SZ-A reduces postprandial blood glucose fluctuations more than Ins+Met and Ins groups. TRIAL REGISTRATION NUMBER: ISRCTN20835488. CI - Copyright (c) 2023 Meng, Xu, Liu, Gao, Li, Lin, Ma, Yang, Hao, Zhao, Hu, Wang and Kuang. FAU - Meng, Ziyu AU - Meng Z AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Xu, Chengye AU - Xu C AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Liu, Haoling AU - Liu H AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Gao, Xinyuan AU - Gao X AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Li, Xinyu AU - Li X AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Lin, Wenjian AU - Lin W AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Ma, Xuefei AU - Ma X AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Yang, Changwei AU - Yang C AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Hao, Ming AU - Hao M AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Zhao, Kangqi AU - Zhao K AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Hu, Yuxin AU - Hu Y AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Wang, Yi AU - Wang Y AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Kuang, Hongyu AU - Kuang H AD - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20231102 PL - Switzerland TA - Front Endocrinol (Lausanne) JT - Frontiers in endocrinology JID - 101555782 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin) RN - 0 (Insulin) RN - 0 (Lipids) RN - 9100L32L2N (Metformin) SB - IM MH - Humans MH - Blood Glucose MH - *Diabetes Mellitus, Type 2 MH - Glycated Hemoglobin MH - Insulin/therapeutic use MH - Lipids MH - *Metformin/therapeutic use MH - *Morus PMC - PMC10653384 OTO - NOTNLM OT - blood glucose fluctuations OT - continuous glucose monitors OT - metformin OT - mulberry twig alkaloids OT - premixed insulin COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/11/29 18:42 MHDA- 2023/12/01 06:44 PMCR- 2023/01/01 CRDT- 2023/11/29 17:02 PHST- 2023/08/03 00:00 [received] PHST- 2023/10/12 00:00 [accepted] PHST- 2023/12/01 06:44 [medline] PHST- 2023/11/29 18:42 [pubmed] PHST- 2023/11/29 17:02 [entrez] PHST- 2023/01/01 00:00 [pmc-release] AID - 10.3389/fendo.2023.1272112 [doi] PST - epublish SO - Front Endocrinol (Lausanne). 2023 Nov 2;14:1272112. doi: 10.3389/fendo.2023.1272112. eCollection 2023.