Abstract
Aim
The present study aimed to evaluate the combined effect of both dose and duration of metformin therapy on vitamin B12 levels in patients with type 2 diabetes mellitus (T2D).
Methods
We recruited 2887 patients with T2D between January 2018 and November 2019 and categorized them into two groups (metformin and non-metformin users) matched for age, mean duration of diabetes, and BMI. We calculated the “Metformin Usage Index” (MUI) which was defined as the product of the dose of metformin (mg) used and its duration divided by 1000. Vitamin B12 levels were compared between the two groups, and its association with MUI was assessed using correlation and multistep logistic regression analyses.
Results
Vitamin B12 levels < 200 pg/ml and between 200 and 300 pg/ml were noted among 24.5% and 34.5% metformin users, respectively; this was significantly higher than among non-metformin users (17.3% and 22.6%, respectively) [P < 0.001]. Overall, a vitamin B12 level < 300 pg/ml was found in 52.2% of the subjects. There was a significant association between an MUI > 5 and a high risk of vitamin B12 deficiency [P < 0.01]. The highest risk was observed among patients with an MUI > 15 [odds ratio (OR) 6.74, 95% CI 4.39–10.4] followed by patients with an MUI > 10 (OR 5.12, 95% CI 3.12–8.38).
Conclusions
The MUI can be employed as a risk assessment tool for evaluation of vitamin B12 deficiency in patients with T2D. Further prospective studies are required to determine the MUI thresholds in populations with good nutritional statuses and low prevalence of vitamin B12 deficiency.
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Acknowledgements
The authors wish to thank Yalamanchi Aiswarya and Biswas Anupam for their help in the study organization, Atluri Sridevi for her assistance with recruitment and data collection, and Sumitra Selvan for her help with data processing. We would also like to thank all the participants of the study.
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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for the profit sectors.
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This study was a part of larger research project titled “Determinants of diabetic peripheral neuropathy in Indian patients with T2D.” The project was approved by the Vydehi Institutional Ethical Committee.
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Shivaprasad, C., Gautham, K., Ramdas, B. et al. Metformin Usage Index and assessment of vitamin B12 deficiency among metformin and non-metformin users with type 2 diabetes mellitus. Acta Diabetol 57, 1073–1080 (2020). https://doi.org/10.1007/s00592-020-01526-4
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DOI: https://doi.org/10.1007/s00592-020-01526-4