Effects of Atorvastatin;CoenzymeQ10;Flaxseed oil; Melatonin and Curcumin on glycemic control; lipid profile; oxidative stress and inflammatory processes in type 2 diabetic patients

Glycemic control and prevention of secondary complications are the most important aims of using pharmacological treatment in diabetes mellitus. The inadequate responses to oral hypoglycemic agents may be attributed to inadequate post-receptor events even when insulin levels are quite sufficient, and mostly related to oxidative stress induced by long term hyperglycemia, dyslipidemia is a modifiable cardiovascular disease risk factor that remains largely uncontrolled in patients with type 2 diabetes . There has been increasing demand for using herbal products with antidiabetic activity due to low cost, easy availability and lesser side effects. The administration of antioxidants like coenzyme-Q10 and melatonin may improve tissue responses to insulin and increase the efficacy of drugs which act through this pathway like Sulfonylurea. The aim of the study to investigate the effectiveness of atorvastatin, Co- Q10, flaxseed oil, curcumin, and melatonin that possess antioxidant; anti-inflammatory and/or hypolipidemic effects on the changes that occur in patients with type 2 diabetes mellitus due to uncontrolled glycemic status. This study was carried out in The Specialized Center for Endocrinology and Diabetes, Baghdad between (October 2011 to April 2013) on (120) diabetic patients , but only (84) patients (54 female and 30 male) completed the study. All participants are selected after giving their informed consent, their age range 35-60 years , and have disease duration of 5-10 years. Sex and age- matched normal healthy subjects. All patients complaining from other diseases than type 2 diabetes mellitus were excluded from the study. This study was approved by ethical committee of Al-Nahrain college of medicine. Patients allocated to 6 groups, first group was treated with placebo (starch 50mg) n=13 , while other groups were treated with [atorvastatin 20mg/day (n=14) ,Coenzyme-Q10 150mg/day (n=14) , Flaxseed oil 1gm/day(n=16), melatonin 10mg/day( n=14), and Curcumin 1gm/day( n=13)] in addition to the already given oral hypoglycemic agent (glibenclamide) and dietar control for 12 Weeks. In addition to that, (25) apparently healthy subjects were involved in the study as control group for comparison. To each group, the following biochemical parameters were done at baseline ;after 6 weeks and after 12 weeks periods: Fasting serum glucose; glycated hemoglobin; lipid profile; oxidative stress parameters(GSH, MDA, SOD, ox-LDL); TNF-α; c- reactive protein; kidney function and liver function tests according to the standard methods. The results showed significant increase in serum levels of FBS, HbA1C, s. Ch, TG, LDL, MDA, Oxidized LDL, TNF-α and CRP, and significant decrease in the levels of s.GSH and s.SOD in patients with type 2DM in comparism with healthy subjects. Administration of Coenzyme-Q10; Flaxseed oil ; melatonin or Curcumin to patients significantly reduced serum FBS, HbA1C, s. Ch, TG, LDL, MDA, Oxidized LDL, TNF-α and CRP levels, and significantly increased s.GSH and s.SOD levels, however, the effects on these parameters were variable between the studied groups. The administration of Coenzyme-Q10; Flaxseed oil ; melatonin or Curcumin to patients with type 2DM when used as adjuvant therapy, could improve both glycemic control and lipid profile with consequent beneficial effects on oxidative stress and inflammatory markers Atorvastatin may disrupt glycemic control in type 2 diabetic patients.