Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.
Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, Changsha, China.
Diabetes Metab Res Rev. 2020 Jul;36(5):e3298. doi: 10.1002/dmrr.3298. Epub 2020 Feb 20.
This trial was conducted to explore the protective effect on β-cell function of adding vitamin D3 to DPP-4 inhibitors to treat patients with latent autoimmune diabetes in adults (LADA).
60 LADA patients were randomized to group A (n = 21) - conventional therapy with metformin (1-1.7 g/day) and/or insulin treatment; group B (n = 20) - saxagliptin (5 mg/day) plus conventional therapy; and group C (n = 19) - vitamin D3 (2000 IU/day) plus saxagliptin and conventional therapy for 12 months. Fasting and 2-hour postprandial blood samples were collected to measure blood glucose, glycosylated hemoglobin and C-peptide levels at baseline and after 3, 6 and 12 months of treatment.
During the 12 months of follow-up, the levels of fasting C-peptide (FCP), 2-hour postprandial C-peptide (PCP) and the C-peptide index (CPI, serum C-peptide-to-plasma glucose level ratio) were maintained in group C. In contrast to those in group A and group B, FCP levels decreased significantly in group B, and CPI levels declined significantly in group A during the 1-year treatment (P < .05). Additionally, the levels of GADA titers in group C significantly decreased compared with those at baseline (P < .05), but no significant differences in GADA titers levels were detected in group A and group B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titers.
The data suggested that adding 2000 IU/day vitamin D3 to saxagliptin might preserve β-cell function in patients with LADA.
本试验旨在探讨在治疗成人隐匿性自身免疫性糖尿病（LADA）患者时，将维生素 D3 添加到 DPP-4 抑制剂中对β细胞功能的保护作用。
将 60 名 LADA 患者随机分为 A 组（n=21）-二甲双胍（1-1.7 g/天）和/或胰岛素常规治疗；B 组（n=20）-沙格列汀（5 mg/天）加常规治疗；C 组（n=19）-维生素 D3（2000 IU/天）加沙格列汀和常规治疗，共 12 个月。治疗前及治疗后 3、6、12 个月采集空腹及餐后 2 小时血样，检测血糖、糖化血红蛋白及 C 肽水平。
在 12 个月的随访期间，C 组空腹 C 肽（FCP）、餐后 2 小时 C 肽（PCP）及 C 肽指数（CPI，血清 C 肽与血糖比值）水平维持不变。与 A 组和 B 组相比，B 组 FCP 水平显著下降，A 组 CPI 水平在 1 年治疗期间显著下降（P<0.05）。此外，与治疗前相比，C 组 GADA 滴度显著下降（P<0.05），而 A 组和 B 组 GADA 滴度无显著差异。三组间 FCP、PCP、CPI 或 GADA 滴度无显著差异。
数据表明，在沙格列汀的基础上加用 2000 IU/天维生素 D3 可能有助于保护 LADA 患者的β细胞功能。
