1Research Scholar, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu- 608002, India.
2*Assistant Professor, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu 608002, India. E-Mail: veeramani9282@gmail.com. ORCID: https://orcid.org/0000-0002-1362-1741 (Corresponding Author)
3Associate Professor, Department of Pharmaceutics, MB School of Pharmaceutical Sciences, MB University, Tirupati, Andhra Pradesh 517102, India.
Background: Type 2 Diabetes Mellitus (T2DM) is a common metabolic disorder often associated with diabetic peripheral neuropathy manifested by pain, paresthesia and sensory impairment. The first line treatment for T2DM, metformin has been associated with decreased intestinal uptake of vitamin B12 with prolonged use. (de Jager et al., 2010; Reinstatler et al., 2012) Vitamin B12 deficiency may therefore play a role in the neurological dysfunction and aggravate neuropathic symptoms. However, the link between vitamin B12 levels and the severity of neuropathic pain in metformin-treated patients is still not adequately examined.
Method: This is a cross-sectional observational study which was conducted at the Department of General Medicine, Guntur General Hospital (GGH), which is a tertiary care teaching hospital serving a diverse semi-urban and rural population. The study was carried out in a period of a year i.e. December 2023 - December 2024.
Results: Mean age of participants was 61.1 ± 10.6 years. Vitamin B12 deficiency was seen in 25.6% of the patients and clinical neuropathy (DN4 ≥ 4) was present in 33.6% of the cohort. Neuropathy was much more common in vitamin B12-deficient (81.2%) and normal vitamin B12 level patients (12.6%). Serum vitamin B12 levels had a significant inverse correlation with the VAS pain scores (rs = -0.527, p < 0.001). Multivariable regression confirmed that lower levels of vitamin B12 were an independent predictor of lower neuropathic pain levels.
Conclusion: Vitamin B12 deficiency is seen in high percentages of metformin-treated patients with T2DM and is highly correlated with a greater level of neuropathic pain. Routine monitoring and supplementation may help to decrease neuropathic complications.
KEYWORDS: Type 2 Diabetes; Vitamin B12 Deficiency; Diabetic Peripheral Neuropathy; Neuropathic Pain; DN4 Score; Cobalamin.
How to cite this article: Vattem J, Veeramani G, Varalaxmi S. Correlation Between Serum Vitamin B12 Levels and Neuropathic Pain Severity in Patients with Type 2 Diabetes Mellitus: A Cross-Sectional Study. Int J Drug Deliv Technol. 2026;16(12s): 37-43. DOI: 10.25258/ijddt.16.12s.6
Source of support: Nil.
Conflict of interest: None