All India Institute of Medical Sciences, Bhubaneswar, 751019, India.
Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar, 751019, India.
Complement Ther Med. 2020 Sep;53:102526. doi: 10.1016/j.ctim.2020.102526. Epub 2020 Jul 22.
This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus.
STUDY DESIGN & INTERVENTION: This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups - Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks.
HbA1c improved significantly in Groups B and C [median changes from baseline - 1.2 % (- 13 mmol/mol) and - 1.5 % (- 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups.
Add-on supplementation with vitamin B12 improved glycaemic control and insulin resistance in patients with type 2 diabetes mellitus.
本研究旨在调查和比较在 2 型糖尿病患者中添加叶酸和维生素 B12 补充剂对血糖控制、胰岛素抵抗和血清脂质谱的影响。
这是一项随机、多臂、开放标签的临床试验。纳入了 80 名服用稳定口服降糖药的 2 型糖尿病患者，将他们随机分为四组，每组 20 人：A 组：添加叶酸（5mg/天）；B 组：添加甲钴胺（500mcg/天）；C 组：添加叶酸（5mg/天）+甲钴胺（500mcg/天）；D 组：标准口服降糖药物。患者在 8 周后进行随访。
与 D 组相比，B 组和 C 组的 HbA1c 显著改善[中位数变化分别为-1.2%（-13mmol/mol）和-1.5%（-16mmol/mol），p 值分别为 0.04 和 0.02]。与 D 组相比，B 组和 C 组的血浆胰岛素、胰岛素抵抗和血清脂联素也有显著改善。与标准治疗相比，所有添加补充剂的三组患者的血清同型半胱氨酸均显著下降。但各组的血脂谱均未得到改善。
在 2 型糖尿病患者中添加维生素 B12 补充剂可改善血糖控制和胰岛素抵抗。
