The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity

INTERVENTION: Intervention 1: Intervention group will receive daily 3 tablets of silymarin with meal for 45 days (each tablets of silymarin contains 140 milligrams pure silymarin). silymarin tablets will be purchased from the Livergol ®; Goldaru Herbal Products Pharmaceutical Company. All the patients will receive the tablets on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews and 2‐weeks check lists. Intervention 2: The control group will receive daily 3 tablets of placebo with meal for 45 days. (Placebo tablets will be produced at the faculty of pharmacy of Tabriz University of medical sciences). Intervention group will receive daily 3 tablets of silymarin with meal for 45 days (each tablets of silymarin contains 140 milligrams pure silymarin). silymarin tablets will be purchased from the Livergol ®; Goldaru Herbal Products Pharmaceutical Company. All the patients will receive the tablets on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews and 2‐weeks check lists. Placebo The control group will receive daily 3 tablets of placebo with meal for 45 days. (Placebo tablets will be produced at the faculty of pharmacy of Tabriz University of medical sciences). Treatment ‐ Drugs CONDITION: E10,E11,E1 Non‐insulin‐dependent diabetes mellitus Type 2 diabetes. ; Non‐insulin‐dependent diabetes mellitus PRIMARY OUTCOME: Fasting blood glucose. Timepoint: Baseline and after 45 days of intervention. Method of measurement: Enzymatic colorimetric. Fasting insulin serum. Timepoint: Baseline and after 45 days of intervention. Method of measurement: ELISA assay. GPX activity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. Hs‐CRP. Timepoint: Baseline and after 45 days of intervention. Method of measurement: immunoturbidimetry. Insulin resistance. Timepoint: Baseline and after 45 days of intervention. Method of measurement: HOMA‐IR calculation. Lipid profiles (TC, TG, LDL‐C, HDL‐C). Timepoint: Baseline and after 45 days of intervention. Method of measurement: Enzymatic methods for TC,TG and HDL‐C For LDL‐C : Freidwald’s formula: LDL‐C = TC‐ HDL‐C ‐ (TG/5). Serum malondialdehyde (MDA). Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. Serum total antioxidant capacity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. SOD activity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. SECONDARY OUTCOME: Anthropometric index(weight, height,WHR and Body Mass. Timepoint: before and after 45 days intervention. Method of measurement: Analogue scale for weight and weight(Kg)/Square Height for body mass index. Calorie and nutrients intake. Timepoint: before and after 45 dyas intervention. Method of measurement: 24‐h recall Questionnaire. Systolic and diastolic blood pressure. Timepoint: before and after 45 days intervention. Method of measurement: standard barometer. INCLUSION CRITERIA: INCLUSION CRITERIA: Type 2 diabetes for at least 6 months; age between 20‐50 (both of gender) years and usage of blood glucose lowering drugs. Exclusion criteria: usage of nutritional supplements in the past 3 months or during the study; usage of insulin; Pregnancy or lactation; BMI more than 35 and lower than 27; Renal and liver failure; Cardiovascular disease; Thyroid disorders; History of allergy; Smoking; Alcohol usage; Following a specific diet; Taking corticosteroids or Immunosuppressive drugs,…