Abstract

Background and ObjectiveOxidative stress plays an important role in pathogenesis of diabetes mellitus and its complications. Our previous study has shown glucose lowering effect produced by 3 months supplementation of Nigella sativa (NS) in combination with oral hypoglycemic drugs among type 2 diabetics. This study explored the long term glucose lowering effect (over one year) of NS in patients with type 2 diabetes mellitus on oral hypoglycemic drugs and to study its effect on redox status of such patients.Methods114 type 2 diabetic patients on standard oral hypoglycemic drugs were assigned into 2 groups by convenience. The control group (n = 57) received activated charcoal as placebo and NS group (n = 57) received 2g NS, daily, for one year in addition to their standard medications. Fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), C- peptide, total antioxidant capacity (TAC), superoxide dismutase (SOD), catalase (CAT), glutathione and thiobarbituric acid reactive substances (TBARS) at the baseline, and every 3 months thereafter were determined. Insulin resistance and β-cell activity were calculated using HOMA 2 calculator.ResultsComparison between the two groups showed a significant drop in FBG (from 180±5.75 to 180±5.59 in control Vs from 195±6.57 to 172 ±5.83 in NS group), HbA1c (from 8.2±0.12 to 8.5±0.14 in control VS from 8.6±0.13 to 8.2±0.14 in NS group), and TBARS (from 48.3±6.89 to 52.9 ±5.82 in control VS from 54.1±4.64 to 41.9 ±3.16 in NS group), in addition to a significant elevation in TAC, SOD and glutathione in NS patients compared to controls. In NS group, insulin resistance was significantly lower, while β-cell activity was significantly higher than the baseline values during the whole treatment period.ConclusionLong term supplementation with Nigella sativa improves glucose homeostasis and enhances antioxidant defense system in type 2 diabetic patients treated with oral hypoglycemic drugs.Trial RegistrationClinical Trials Registry-India (CTRI) CTRI/2013/06/003781

Highlights

  • Diabetes mellitus (DM) is a common chronic disease that affects people of all ages and races and imposes a large economic burden on the health care system

  • This study explored the long term glucose lowering effect of Nigella sativa (NS) in patients with type 2 diabetes mellitus on oral hypoglycemic drugs and to study its effect on redox status of such patients

  • Comparison between the two groups showed a significant drop in Fasting blood glucose (FBG), HbA1c, and thiobarbituric acid reactive substances (TBARS), in addition to a significant elevation in total antioxidant capacity (TAC), superoxide dismutase (SOD) and glutathione in NS patients compared to controls

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Summary

Introduction

Diabetes mellitus (DM) is a common chronic disease that affects people of all ages and races and imposes a large economic burden on the health care system. DM is characterized by chronic elevation of blood glucose which is a central factor in the production of reactive oxygen species (ROS) that, in turn, promote cellular damage and contribute to the development and progression of diabetic complications.[1, 2]. Pancreatic β-cells are susceptible to damage by oxidative stress when exposed to chronic hyperglycemia [3] because they are low in free-radical quenching enzymes.[4] Further, ROS can suppress the insulin response and contribute to the development of insulin resistance, a key pathological feature of type 2 DM.[5] adequate glycemic control is essential for preventing complications associated with type 2 diabetes. This study explored the long term glucose lowering effect (over one year) of NS in patients with type 2 diabetes mellitus on oral hypoglycemic drugs and to study its effect on redox status of such patients

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