A comparative study of efficacy and safety of anti-oxidants as an add-on therapy to metformin on glycemic parameters in newly diagnosed type 2 diabetes mellitus patients at a tertiary care hospital

Authors

  • Yashaswini P. Department of Pharmacology, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka, India
  • Geetha A. Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India
  • Ravi K. Department of Medicine, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20212919

Keywords:

Diabetes mellitus, Oxidative stress, Metformin, Vitamin C, Vitamin E

Abstract

Background: Oxidative stress plays major role in diabetes mellitus (DM), abnormal high free radicals decline antioxidant defence mechanism can lead to damage of cellular organelles and enzymes, increased lipid peroxidation and insulin resistance leads to development of complications. Supplementation of antioxidants protects free radical induced damage and further complications. The objective was to evaluate the efficacy and safety of metformin versus metformin with vitamin C and E on glycaemic parameters in newly diagnosed type 2 diabetes mellitus (T2DM).

Methods: 60 newly diagnosed T2DM patients were randomized into two groups of 30 in each to receive metformin (500 mg BD) alone in group A versus metformin (500 mg BD)+vitamin C (500 mg OD)+vitamin E (400 mg OD) in group B for 12 weeks. Efficacy was measured by improvement in glycaemic (FBS fasting blood sugar, PPBS postprandial blood sugar and HbA1c glycosylated haemoglobin) parameters at week 4, 8 and 12 from baseline. Safety was assessed by monitoring treatment emergent adverse effects.

Results: The baseline characteristics were comparable between the two groups. There was a significant reduction of glycaemic parameters seen in both the groups from baseline to week 12 (p<0.001) but the difference was not statistically significant between the two groups (p>0.05). No significant adverse effects were noted.

Conclusions: Both the groups are effective in improving glycaemic indices and supplementation of vitamins along with metformin as compared to metformin alone with no significant adverse effect. Hence, daily consumption of vitamins may be beneficial in decreasing blood glucose in patients with T2DM and thus reducing the risk of complications.

References

Rang HP, Dale MM, Ritter JM. The control of blood glucose and drug treatment of diabetes mellitus. Rang and Dale's pharmacology. 7th ed. Edinburgh: Elsevier/Churchill Livingstone; 2012: 378.

Diabetes Care. Fact sheet: Introduction: standards of medical care in diabetes-2018. Available at: http://care.diabetesjournals.org/content/41/Supplement_1. Accessed on 01 June 2021.

Powers AC, D’Alessio D. Endocrine pancreas and pharmacotherapy of diabetes mellitus and hypoglycaemia. In: Goodman L, Goodman L, Brunton L, Lazo J, Parker K, eds. The pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill; 2011: 1258.

Johansen J, Harris A, Rychly D, Ergul A. Oxidative stress and the use of antioxidants in diabetes: Linking basic science to clinical practice. Cardiovas Diabetol. 2005;4(1):5.

Ahmad N, Rahmat A, Mushtaq A, Nadia M. Role of antioxidant in oxidative stress and diabetes mellitus. J Pharmacogn Phytochem. 2015;3(6):217-20.

Ayepola O, Brooks N, Oguntibeju O. Oxidative stress and diabetic complications: the role of antioxidant vitamins and flavonoids. Antioxid Antidiabet Agent Human Health. 2014:27-58.

Kathore VR, Bansode DG. The effect of vitamin c on fasting blood glucose level and lipid profile in type-2 diabetes mellitus patients. Int J Rec Trend Sci Technol. 2014;16(3):585-90.

El-Aal AA, El-Ghffar EAA, Ghali AA, Zughbur MR, Sirdah MM. The effect of vitamin C and/or E supplementations on type 2 diabetic adult males under metformin treatment: A single-blinded randomized controlled clinical trial. Diabetes Metab Syndr. 2018;12(4):483-9.

Hamed AT, Zinati SMA, Swirky AA. The effect of vitamin C alone or in combination with vitamin E on fasting blood glucose, glycosylated hemoglobin and lipid profile in type 2 diabetic patients (Gaza Strip). Jordan J Pharmaceut Sci. 2016;9(1):12-24.

Gillani SW, Sulaiman SAS, Abdul MIM, Baig MR. Combined effect of metformin with ascorbic acid versus acetyl salicylic acid on diabetes-related cardiovascular complication; a 12-month single blind multicenter randomized control trial. Cardiovascular Diabetol. 2017;16(1):103-16.

Dakhale GN, Chaudhari HV, Shrivastava M. Supplementation of vitamin C reduces blood glucose and improves glycosylated hemoglobin in type 2 diabetes mellitus: a randomized, double-blind study. Adv Pharmacol Sci. 2011;11:1-5.

Bhatt JK, Thomas S, Mj N. Effect of oral supplementation of vitamin C on glycemic control and lipid profile in patients with type 2 diabetes mellitus. Int J Pharm Pharmaceut Sci. 2012;4(2):524-7.

Rafighi Z, Arab S, Yusof MR, Shiva A. The effect of vitamin c and e on lipid profile in type 2 diabetes mellitus patients. Glob J Health Sci. 2011;3(2):69-74.

Nath RK, Akhter M, Sarker KR, Rahman MR, Chowdhury SS, Ishrat R. Effect of vitamin C on blood glucose & serum lipids in type 2 diabetes patients. KYAMC J. 2013;4(1):337-40.

Kuchake VG, Upasani DCD. Evaluation of protective effect of antioxidant vitamins in patients with diabetic nephropathy. Asian J Pharmaceut Clinic Res. 2011;4(4):52-4.

Downloads

Published

2021-07-26

How to Cite

P., Y., A., G., & K., R. (2021). A comparative study of efficacy and safety of anti-oxidants as an add-on therapy to metformin on glycemic parameters in newly diagnosed type 2 diabetes mellitus patients at a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 10(8), 925–931. https://doi.org/10.18203/2319-2003.ijbcp20212919

Issue

Section

Original Research Articles