Diabetes mellitus. Non-insulin dependent diabetes mellitus
Conditions
Interventions
Intervention 1: 1.8 g Omega-3 plus 400 mg vitamin E. Intervention 2: 300 mg Vitamin C plus 5 mg zinc. Intervention 3: Placebo capsule containing 500 mg canola oil.
Treatment - Drugs
1.8 g Omega-3 plus 400 mg vitamin E
300 mg Vitamin C plus 5 mg zinc
Placebo capsule containing 500 mg canola oil
Sponsors
National Nutrition and Food Technology Research Institute
Vice chancellor for Research of Kerman University of Medical Sciences.
Minami Nutrition Co.
PouraTeb Medical & Pharmaceutical Company
HakimanTeb Pharmaceutical Company
Eligibility
Sex/Gender
Female
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: willingness to participate in the study and sign the informed consent, postmenopausal women with age of 50 to 65 years, presence of type 2 diabetes at least for one year (according to the American Diabetes Association criteria), non-insulin therapy, receiving either diet therapy or diet therapy with combination of oral anti-diabetic medications, no history of myocardial infarction, stroke, cardiovascular disease, active cancer, liver, kidney and thyroid dysfunction, or infectious diseases, Exclusion criteria: changing in dose of medications such as oral anti-diabetic, anti-lipidemic and anti-hypertensive drugs, occurrence of myocardial infarction, stroke, active cancer, liver, kidney, thyroid dysfunction, or infectious diseases, changing in drug regimen or insulin therapy, smoking, consumption of anti-oxidant vitamin supplements and fish oil capsules, non-steroidal anti inflammatory drugs, corticosteroids, anti-platelets or anti-coagulation drugs three months prior to study, hormone replacement therapy.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting insulin serum. Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Fasting blood glucose. Timepoint: Baseline and after 12 weeks. Method of measurement: Glucose oxidase, Enzymatic colorimetric.;HbA1C (Glycosilated hemoglobin). Timepoint: Baseline and after 12 weeks. Method of measurement: Ion exchange method.;Insulin resistance. Timepoint: Baseline and after 12 weeks. Method of measurement: HOMA-IR calculation.;Serum triglyceride. Timepoint: Baseline and after 12 weeks. Method of measurement: Glycerol phosphate oxidase, Enzymatic colorimetric.;Total cholestrol. Timepoint: Baseline and after 12 weeks. Method of measurement: Enzymatic photometric.;HDL-cholestrol. Timepoint: Baseline and after 12 weeks. Method of measurement: Enzymatic photometric.;LDL-cholestrol. Timepoint: Baseline and after 12 weeks. Method of measurement: Friedewald formula.;Apo lipoprotein B100. Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;HsC-Reactive Protein. Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Tumor Necrosis Factor-a. Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Interleukin-6. Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Fibrinogen. Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Tissue-plasminogen activator (t-PA). Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Plasminogen activator inhibitor-1 (PAI-1). Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Ox-LDL. Timepoint: Baseline and after 12 weeks. Method of measurement: ELISA assay.;Malonedialdehyde (MDA). Timepoint: Baseline and after 12 weeks. Method of measurement: TBARS, Chemical colorimetric.;Total antioxidant capacity (TAC). Timepoint: Baseline and after 12 weeks. Method of measurement: Colorimetric.;SOD. Timepoint: Baseline and after 12 weeks. Method of measurement: Kit Jaica.;GPX. Timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Medical events with special focus on cardiovascular. Timepoint: Baseline and every week until the end of intervention. Method of measurement: She was asked for any medical and activity conditions by investigator week to week or any time the patients want to call first executor and research doctor (councellor).;Clinical and emotional improvement. Timepoint: Baseline and every week until the end of intervention. Method of measurement: She was asked for any medical and activity conditions by investigator week to week or any time the patients want to call first executor and research doctor (councellor). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Reza Mahmoodi
Department of Nutrition, School of Health
Outcome results
None listed