Abstract
Background: Neuropathy is the most prevalent broad-spectrum microvascular complication of diabetes. The present study aims to evaluate the effect of empagliflozin with vitamin D supplementation on diabetic peripheral neuropathy.Methods: A prospective, randomized, controlled study was conducted for six months including 150 type 2 diabetic patients, divided into three groups (n=50/group): Group 1, patients on oral hypoglycemic agents; Group 2, patients on empagliflozin and Group 3, patients on empagliflozin with vitamin D. Biochemical parameters were estimated for outcome measurements and patients’ neuropathic pain was analysed using Douleur Neuropathique 4 Questions, Neuropathic Pain Symptom Inventory and Ipswich Touch the toes test questionnaire. Data were analysed using a one-way analysis of variance.Results: Diabetic neuropathy in males was more prevalent (more than 50%) as compared to females in all three groups, with an average age of 50±6 years, along with a diabetic history of 15±4.5 years and a glycated hemoglobin A1C (HbA1C) level of >10%. The mean value of serum vitamin D level significantly increased by 64.7% (19±5 to 54±8 ng/mL; p<0.05). A remarkable decrease (by 17.4%) from baseline in the HbA1C level was observed after six months of treatment only in Group 3, whereas in other groups (1 and 2), there was a non-significant decrease in HbA1C levels when compared to baseline. Moreover, a significant improvement in neuropathic condition was seen only in Group 3.Conclusion: The results indicated that empagliflozin with vitamin D supplementation significantly controlled or reduced HbA1C and improved diabetic neuropathic symptoms in patients. It is suggested that this combination can be considered as the primary therapeutic approach for neuropathic complications in diabetic patients.
Highlights
Diabetes mellitus (DM) is the largest global epidemic of the 21st century and is associated with various complications classified as microvascular and macrovascular [1]
The present study was a cross-sectional, observational, open-label randomized controlled study of sixmonth duration, which evaluated the therapeutic effect of a new class of anti-diabetic drug, i.e. sodium-glucose cotransporter-2 inhibitors (SGLT2i) with vitamin D on diabetic neuropathic pain in type 2 DM patients
A total of 150 type 2 DM patients were divided into three groups; the majority of patients affected from diabetes were males as compared to females in all three groups
Summary
Diabetes mellitus (DM) is the largest global epidemic of the 21st century and is associated with various complications classified as microvascular and macrovascular [1]. Microvascular complications include dysfunction of the nervous system (diabetic neuropathy), renal system (diabetic nephropathy), and ocular system (diabetic retinopathy). The most prevalent and broad-spectrum microvascular complication with DM is neuropathy [2]. It is well known that DM is a result of insulin resistance caused by an inflammatory state associated with elevated cytokine levels through which oxidative stress causes endothelial cell dysfunction [5]. Vitamin D controls DM by lowering the C-reactive protein (CRP) levels and reducing insulin resistance along with preventing cardiovascular abnormalities by improving endothelial function. Neuropathy is the most prevalent broad-spectrum microvascular complication of diabetes. The present study aims to evaluate the effect of empagliflozin with vitamin D supplementation on diabetic peripheral neuropathy
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