الفهرس 
Review of Literature
Anti-Diabetic Drugs Used by Patients in the Current StudyOnly 14 pages are availabe for public view
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Abstract
Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. Poorly controlled Type 2 diabetes mellitus is associated with an array of microvascular, macrovascular, and neuropathic complications.
During diabetes, persistent hyperglycemia causes increased production of free radicals, especially reactive oxygen species (ROS), as a result of glucose auto-oxidation and protein glycosylation.
Oxidative stress can occur as a result of either excess ROS production, or impaired antioxidant system, or a combination of them. The primary ROS produced in the course of oxygen metabolism is superoxide, which is a highly reactive, cytotoxic ROS. Superoxide is dismutated to a far less reactive product, hydrogen peroxide (H2O2), by a family of metalloenzymes known as superoxide dismutase (SOD).
In the same time GSH is by far the most important antioxidant in most mammalian cells. GSH has the important function of destroying reactive oxygen intermediates and free radicals that are constantly formed in metabolism.
Alternative medicine has opened new door for the treatment of metabolic disorders which has attained high proportion throughout the world. Nigella sativa has been reported to have a potential antioxidant activity. Also, in animal studies TQ produced a significant increase in hepatic antioxidant enzymes such as SOD and GPx, and produced a decrease in cellular oxidative stress. In addition, Nigella sativa has reported a number of medicinal properties such as anti-inflammatory, antiviral, antiepileptic and cytotoxic effect. Moreover, preliminary results of animal studies of black seed oil on diabetes suggested that black seed oil might possess an anti-diabetogenic activity.
Accordingly the current study was designed to evaluate the effectiveness of Nigella Sativa seed oil as adjuvant therapy for type 2 DM patients. Moreover, we evaluated the antioxidant effect of Nigella sativa, by measuring SOD and GPx.
The study was conducted on 43 type 2 diabetic patients, All patients with age between 40-60 years, type 2 DM (receiving oral hypoglycemic drugs either gliclazide as a member of sulphonylurea; Metformin or combination of both.), uncontrolled on their usual antidiabetic drug , and not taking Nigella sativa in any other form were assessed for eligibility. Pregnant patients, type 1 diabetes mellitus patients, presence of end organ damage as renal failure and patients on insulin therapy were excluded from the study.
The recruited patients were divided into two groups:
Group (I) (Control Group): comprised 22 type 2 diabetic patients who were kept on their standard antidiabetic regimen prior to the study.
Group (II) (Study Group): comprised 21 type 2 patients who were kept on their standard antidiabetic regimen plus Nigella sativa seed oil (provided as soft gelatin capsules 450 mgof black seed oil twice daily equivalent to 1 ml oil /day).
A blood sample was withdrawn from each patient at baseline, after 3 months and after 6 months of therapy. For both groups the following were screened:
A. Demographic & Clinical Data: included (Age, Sex, Height, Weight, W/H ratio Blood pressure and calculated BMI)
B. Biochemical Laboratory Tests Included:
Blood Sugar: (FBG, PPBG and HbA1c)
Lipid Profiles: Cholesterol (T.Ch), (HDL), (LDL) and (TGs)
Kidney Function Test: serum creatinine (S.cr)
Liver Function Tests: Alanine Transaminases (ALT), Aspartate Transferase (AST)
Antioxidant Parameters: Gpx and SOD.
FBG and PPBG were assessed monthly, whereas HbA1c were assessed at 3 and 6 months of therapy. All patients were screened for their smoking status and the use of nutritional supplements.
Patient’s screening included also, additional medical problems, and concurrent medications. Monthly follow-up of patients included detecting new adverse drug reactions, drug-drug interactions, dietary advice and emphasizing the importance of compliance with their medications.
The current study showed the following:
At baseline: Patients in the two groups were comparable with respect to age, gender, BMI, mean duration of diabetes mellitus and smoking status. Moreover, there were no significant differences between the two groups in terms of the type of antidiabetic drugs used, p=0.513.
Co-morbidities were present in all patients. The most frequent co-morbidity was hypertension (46.5%), followed by hyperlipidemia (41.8%) and coronary artery disease (11.6%).In total, none of the patients had drugs with a potential of interaction with the antidiabetic drugs or with Nigella sativa. Moreover, no statistically significant difference was detected between patients in the two groups regarding the laboratory investigations performed at start of treatment.
After 3 months of treatment: a statistically significant decrease in PPBG was detected in Nigella sativa treated group (Group II) relative to their corresponding levels in the group receiving oral antidiabetic regimen only (Group I) (p = 0.013). On the other hand, no significant difference was detected between the two groups regarding FBG and HbA1c levels.
After 6 months of treatment: a significant decrease in both FBG and PPBG was detected in Group II in comparison to Group I (percentage reduction 15.8%, p=0.007, percentage reduction 17.9%, p = 0.001, respectively). Moreover, a highly significant decrease in the level of HbA1c in the Nigella sativa group (percentage reduction 16.4%., p = 0.004).
This is the first study to evaluate the levels of SOD & Gpx in diabetic patients. Nigella sativa therapy in the present study significantly increased the activity of antioxidant enzymes SOD and Gpx (p < 0.05) On the other hand, in the present study, the six months treatment with Nigella sativa oil showed no effect on C.peptide enzyme, between the two groups. In addition, our study revealed no significant difference in SGOT, SGPT, serum creatinine, TGs, HDL, LDL and total cholesterol levels in black seed oil group compared to control group upon completion of study.