Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers, Combined with Dapagliflozin as Type 2 Diabetes Mellitus Routine Treatment: A Controlled Randomized, Double-blind Trial.

Abstract

Background: 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.

Methods: 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.

Results: 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 %, F(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).

Conclusion: The co-administration of vitamin B12 as a supplement for diabetic patients improved BMI and HbA1c levels.Trial Registration Number: NCT06241638.