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IRCT2014011416223N1 IRCT 2014-01-23 Tabriz University of Medical Sciences The effect of diet therapy as epigenetic factors in the control of diabetic complications The effect of low calorie diet on plasma levels of miR-33b, -375, -935 and -29a, state of insulin ‎resistance and lipid metabolism in obese women with type II diabetes ‎ 2014-01-21 anticipated 20 Complete https://irct.ir/trial/15251 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Type 2 diabetes mellitus. Intervention 1: Intervention group: A 8-week low calorie diet ‎‏)‏based on subtracting 700 calories from standard formula to ‎predict energy expenditure estimated at four levels of physical activity for obese women 19 years old and ‎above‏(‏‎ and planning individual diet based on exchange list.‎. Intervention 2: Control group: without low calorie diet- Continuing with their common diet for 8-week.
public Somayeh Mohammadi
Nutrition department, Faculty of nutrition sciences, Attar neyshabouri street, Golgasht avenue
Tabriz Iran (Islamic Republic of) +98 41133575803 mohammadis.phd@gmail.com Tabriz University of Medical Sciences scientific Somayeh Mohammadi
Public nutrition department, Faculty og nutrition sciences, Attar neyshabouri Avenue, Golgasht street
Tabriz Iran (Islamic Republic of) +98 41133575803 Mohammadis.phd@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria: Women with type 2 diabetes diagnosed at least two years by specialist; The ‎age range of 25 to 60; The degree of obesity in accordance with the definition of a BMI ≤ 45 ‎kg/m2 ≥ 30; Willingness to participate in research.‎ The exclusion criteria: Patients who did not complete the questionnaire; Unwillingness to blood ‎sampling; BMI over 45; Following a special diet like vegetarian diet, low calorie diet or weight-‎loss medications for obesity last year; More than three kilograms of weight change over the past ‎six months; Pregnancy, lactation, menstruation irregular; Chronic cigarette smokers (3 days more ‎than 48 months) or alcohol; Vitamin and mineral supplements; protein and phytoestrogens period ‎of 3 months prior to study entry; Taking hormonal contraceptives, anticonvulsants, ‎glucocorticoids during the recent 3 months; Patients with type 1 diabetes mellitus; Kidney ‎disease, liver disease, hyperthyroidism, a chronic inflammation (such as rheumatoid arthritis, ‎multiple sclerosis, rash, etc.) and a variety of benign and malignant masses.‎ 25 years 60 years Female E11 Non-insulin-dependent diabetes mellitus Treatment - Other Other Intervention group: A 8-week low calorie diet ‎‏)‏based on subtracting 700 calories from standard formula to ‎predict energy expenditure estimated at four levels of physical activity for obese women 19 years old and ‎above‏(‏‎ and planning individual diet based on exchange list.‎ Control group: without low calorie diet- Continuing with their common diet for 8-week Micro RNA-29a. Timepoint: before and 2 month after intervention. Method of measurement: qRT-PCR, copy nomber of micro RNAs per each micro litr of plasma and deffrent percent with interior standard. Micro rna-375. Timepoint: before and 2 month after intervention. Method of measurement: qRT-PCR, copy nomber of micro RNAs per each micro litr of plasma and deffrent percent with interior standard. Micro RNA-33b. Timepoint: before and 2 month after intervention. Method of measurement: qRT-PCR, copy nomber of micro RNAs per each micro litr of plasma and deffrent percent with interior standard. Micro RNA-935. Timepoint: before and 2 month after intervention. Method of measurement: qRT-PCR, copy nomber of micro RNAs/ micro litr of plasma and deffrent percent with interior standard. Fasting serum insulin concentration. Timepoint: before and 2 month after intervention. Method of measurement: ELISA, ‎µU/mL. Plasma insulin concentration 2 hours after meal. Timepoint: before and 2 month after intervention. Method of measurement: ELISA, ‎µU/mL. Serum adiponectin levels. Timepoint: before and 2 month after intervention. Method of measurement: ELISA, ng/dL. Serum TNF-a levels. Timepoint: before and 2 month after intervention. Method of measurement: ELISA, ng/dL. Fasting blood glucose. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric assay, mg/dL. Blood glucose, blood glucose 2 hours after meal. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric assay, mg/dL. Serum total cholestrol. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric assay, mg/dL. Serum LDL-C. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric assay, mg/dL. Serum HDL-C. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric assay, mg/dL. Serum triglyceride level. Timepoint: before and 2 month after intervention. Method of measurement: enzymatic colorimetric assay, mg/dL. Weight. Timepoint: before, 1 and 2 month after intervention. Method of measurement: Scale of body analyzer, Kg. BMI. Timepoint: before, 1 and 2 month after intervention. Method of measurement: Calculating by equation, Kg/m2‎. Waist circumference. Timepoint: before, 1 and 2 month after intervention. Method of measurement: Tape, Centimeter. Hip circumference. Timepoint: before, 1 and 2 month after intervention. Method of measurement: Tape, Centimeter. Waist to hip ratio. Timepoint: before, 1 and 2 month after intervention. Method of measurement: Calculating by equation, cm/cm. Waist to height ratio. Timepoint: before, 1 and 2 month after intervention. Method of measurement: Calculating by equation, m/m. HOMA-IR. Timepoint: before and 2 month after intervention. Method of measurement: HOMA-IR equation. QUICKI. Timepoint: before, 1 and 2 month after intervention. Method of measurement: QUICKI equation. Calorie intake. Timepoint: Before, 1 month and 2 month after intervention. Method of measurement: 3 day food recall and Food frequency questionnaire, Kcal/day. Carbohdrate inake. Timepoint: Before, 1 month and 2 month after intervention. Method of measurement: 3 day food recall and Food frequency questionnaire, g/day. Protein intake. Timepoint: Before, 1 month and 2 month after intervention. Method of measurement: 3 day food recall and Food frequency questionnaire, g/day. Fat intake. Timepoint: Before, 1 month and 2 month after intervention. Method of measurement: 3 day food recall and Food frequency questionnaire,g/day. Shahid Beheshti University of Medical Sciences Tabriz University of Medical Sciences Shahid Beheshti University of Medical Sciences Approved 2013-12-16 Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Research vice-chancellors, Golgasht st, Azadi ave, Tabriz, Iran Tabriz Iran (Islamic Republic of)