Department and Division of Medical Rehabilitation, Wroclaw Medical University, Borowska 213, 50-556, Wrocław, Poland.
Department of Medical Biochemistry, Wroclaw Medical University, Wrocław, Poland.
Sci Rep. 2021 Jun 3;11(1):11684. doi: 10.1038/s41598-021-91174-7.
This prospective study aimed to analyze whether the patients with pre-diabetes (pre-DM) reach the TC (therapeutic concentration) of the metformin during repeated, low, constant drug dose. The guidelines do not recommend any metformin dose for this group of patients. Based on the previous study after a dose of 1700 mg/day the patients seem to reach the therapeutic drug concentration, which guarantees the glycemic effect. Twenty patients with new-diagnosed pre-DM were treated with a 1500 mg/day regimen of the metformin for 15 weeks. The serum concentration of the drug was assessed by liquid chromatography-mass spectrometry technique at 6 and 15 week of the treatment. The correlation of the serum metformin concentration with BMI (body mass index) and patients' weight was also performed. The mean metformin concentration was: 4.65 μmol/L (± 2.41) and 5.41 μmol/L (± 3.44) (p = 0.27) after 6 and 15 weeks of the treatment respectively. There was a positive correlation between the serum concentration of the metformin and body weight (but not BMI) in the 15th week of the therapy (p = 0.04)- the higher body weight the higher concentration of the metformin. Patients with pre-diabetes can be successfully treated with a low dose of metformin, to reach the drug's therapeutic concentration. Body weight can impact the metformin serum concentration during long-term treatment what should be taken into consideration when choosing the dose because of its pleiotropic effect e.g. on the cardiovascular system via reduction of the oxidative stress and would be not connected with the drug's hypoglycemic effect.ClinicalTrials.gov number: NCT03398356; date of first registration: 01/07/2018.
这项前瞻性研究旨在分析患有糖尿病前期(pre-DM)的患者在重复、低、恒定药物剂量下是否能达到二甲双胍的治疗浓度(TC)。该指南不建议为该组患者推荐任何剂量的二甲双胍。基于之前的研究,每天服用 1700 毫克的剂量后,患者似乎达到了治疗药物浓度,从而保证了降糖效果。20 名新诊断为 pre-DM 的患者接受了为期 15 周的 1500 毫克/天的二甲双胍治疗方案。在治疗的第 6 和第 15 周,通过液相色谱-质谱技术评估药物的血清浓度。还对血清二甲双胍浓度与 BMI(体重指数)和患者体重的相关性进行了分析。治疗 6 周和 15 周后,平均二甲双胍浓度分别为:4.65μmol/L(±2.41)和 5.41μmol/L(±3.44)(p=0.27)。治疗第 15 周时,血清二甲双胍浓度与体重呈正相关(但与 BMI 无关)(p=0.04)-体重越高,二甲双胍浓度越高。低剂量的二甲双胍可以成功治疗糖尿病前期患者,使其达到药物的治疗浓度。体重可能会影响长期治疗过程中的二甲双胍血清浓度,在选择剂量时应考虑到这一点,因为它具有多种效应,例如通过降低氧化应激对心血管系统的影响,而与药物的降血糖作用无关。临床试验编号:NCT03398356;首次注册日期:2018 年 7 月 1 日。