Aburayyan Walid, Zakaraya Zainab, Hamad Mohammed, Majali Ibrahim S, Abu Dayyih Wael, Seder Nesrin, Alkhadeir Haneen, Khaleel Anas
Department of Medical Laboratory Analysis, Faculty of Science, Al-Balqa Applied University, Al-Salt, Jordan.
Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, Alahliyya Amman University, Amman, Jordan.
Iran J Med Sci. 2025 May 1;50(5):324-333. doi: 10.30476/ijms.2024.101606.3423. eCollection 2025 May.
Diabetes mellitus is predominantly a growing global problem interconnected proportionally with obesity escalation. The current study evaluated the prognostic implications of vitamin B12 administration on Body Mass Index (BMI) and glycosylated hemoglobin (HbA1c) levels in type 2 diabetic patients treated with dapagliflozin.
In this controlled randomized, double-blind trial, 160 patients for each arm were enrolled from July 2022 to June 2023 in Amman, Jordan.; 76 females and 84 males with inclusion criteria of vitamin B12 less than 233 ng/ml, age between 19-76 years, HbA1c range between 6.8-9.1%, and BMI less than 35. Group I received only dapagliflozin 10 mg/daily for a period of 12 months, whereas, group II received vitamin B12 supplements, methylcobalamin 500 µg, once daily with dapagliflozin 10 mg/day. HbA1c, Vitamin B12, and BMI were measured at time intervals of 0, 6, and 12 months. Using SPSS version 23, P values<0.05 were considered statistically significant. The continuous variables were reported as median and IQR. Mann-Whitney-u test and Correlations Spearman's rho were used for continuous variables.
The co-administration of vitamin B12 significantly decreased the levels of HbA1c in group II (54 participants) to 6.66±0.643 by 0.6 %, (2,78)=172, P<0.001, compared to the subjects in group I (6.92±0.434). A significant impact of vitamin B12 administration on BMI lowering was observed at different time intervals during the study (P=0.002).
The co-administration of vitamin B12 as a supplement for diabetic patients improved BMI and HbA1c levels. NCT06241638.
糖尿病主要是一个日益严重的全球性问题，与肥胖率的上升成比例相关。本研究评估了维生素B12给药对接受达格列净治疗的2型糖尿病患者体重指数（BMI）和糖化血红蛋白（HbA1c）水平的预后影响。
在这项对照随机双盲试验中，2022年7月至2023年6月期间在约旦安曼招募了每组160名患者；76名女性和84名男性，纳入标准为维生素B12低于233 ng/ml，年龄在19至76岁之间，HbA1c范围在6.8%至9.1%之间，BMI低于35。第一组仅接受10 mg/天的达格列净治疗12个月，而第二组接受维生素B12补充剂甲钴胺500 μg，每天一次，与10 mg/天的达格列净联合使用。在0、6和12个月的时间间隔测量HbA1c、维生素B12和BMI。使用SPSS 23版，P值<0.05被认为具有统计学意义。连续变量报告为中位数和四分位数间距。连续变量使用曼-惠特尼U检验和斯皮尔曼等级相关系数。
与第一组受试者（6.92±0.434）相比，第二组（54名参与者）联合使用维生素B12使HbA1c水平显著降低至6.66±0.643，降低了0.6%，(2,78)=172，P<0.001。在研究期间的不同时间间隔观察到维生素B12给药对降低BMI有显著影响（P=0.002）。
联合使用维生素B12作为糖尿病患者的补充剂可改善BMI和HbA1c水平。临床试验注册号：NCT06241638。
