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IRCT20170214032571N10 IRCT 2019-07-28 Oroumia University of Medical Sciences The effect of a low calorie diet in patients with type 2 diabetes The effect of a low calorie diet on metabolic status in normal and overweight patients with type 2 diabetes 2018-06-21 anticipated 120 Complete https://irct.ir/trial/40166 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: During the study, patients have a constant physical activity, Randomization description: The volunteers were randomly assigned to intervention and control groups with normal weight and overweight, and stratified block randomization was performed based on age and sex. N/A Type 2 diabetes. Intervention 1: Intervention group: Group A =Intervention in normal weight diabetes patients by reducing 500kcal of daily energy requirement for 12 months. Intervention 2: Intervention group: Group B = Intervention in overweight diabetes patients by reducing 500kcal of daily energy requirement for 12 months. Intervention 3: Control group: Group C = Normal weight diabetes patients without reducing 500kcal of daily energy requirement for 12 months. Intervention 4: Control group: Group D = Overweight diabetes patients without reducing 500kcal of daily energy requirement for 12 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet
public Majid Monafi
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road
Urmia Iran (Islamic Republic of) 5715799313 +98 44 1278 0803 majidmanafi@yahoo.com Oroumia University of Medical Sciences scientific Majid Monafi
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road
Urmia Iran (Islamic Republic of) 5715799313 +98 44 1278 0803 majidmanafi@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Criteria for inclusion in the study: normal and overweight patients with type 2 diabetes Aged between 18 to 65 Consumption of same drugs (glibenclamide, metformin) 18 years 65 years Both Criteria for exclusion from the study: Suffering from liver diseases Suffering from thyroid disease Pregnancy and lactation Smoking and drinking alcohol Consumption of drugs reducing blood fat and pressure and Weight, thiazide diuretics and corticosteroids Change of type and dosage of consuming drugs during the study Consumption of Herbal or chemical supplements Suffering from Digestive diseases associated with malabsorption Gastric bypass surgery and cholecystectomy Insulin Therapy people who have been on weight loss diet or had been treated with drugs and supplements related to weight loss (such as Orlistat or Slim Last dietary supplements) in the past three months Suffering from diabetic complications such as nephropathy, retinopathy, neuropathy and cardiovascular complications Diabetes m E11 Prevention Prevention Other Other Intervention group: Group A =Intervention in normal weight diabetes patients by reducing 500kcal of daily energy requirement for 12 months Intervention group: Group B = Intervention in overweight diabetes patients by reducing 500kcal of daily energy requirement for 12 months Control group: Group C = Normal weight diabetes patients without reducing 500kcal of daily energy requirement for 12 months Control group: Group D = Overweight diabetes patients without reducing 500kcal of daily energy requirement for 12 months Insulin resistance. Timepoint: At weeks 0, 12. Method of measurement: (fasting serum glucose (mmol/L) × fasting serum insulin (μIU/ml))/22.5. Quantitative Insulin Sensitivity Check Index. Timepoint: At weeks 0, 12. Method of measurement: 1/ [ log(fasting insulin, µU/ml) + log (fasting glucose, mg/dl) ]. Fasting Blood Sugar. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg/dl. Serum insulin. Timepoint: At weeks 0, 12. Method of measurement: Radioimmunoassay. Systolic blood pressure. Timepoint: At weeks 0, 12. Method of measurement: Mercury pressure gauge, Mm mercury. Diastolic blood pressure. Timepoint: At weeks 0, 12. Method of measurement: Mercury pressure gauge, Mm mercury. Body composition analysis (Weight, Body mass index, Fat mass, Fat free mass, Visceral fat area, Waist circle, Waist to hip ratio, Skeletal muscle mass). Timepoint: At weeks 0, 12. Method of measurement: Inbody770 Body Analyzer, Bioelectrical impedance analysis. HbA1c. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, ٪. Lipid profile (Triglyceride,Total cholesterol, VLDL, LDL, HDL‏). Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg / dl. Liver enzymes (ALP, ALT, AST). Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, IU/L. Oroumia University of Medical Sciences Approved 2018-04-17 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, orjans valley, Rresalat boulevard Urmia West Azarbaijan Iran (Islamic Republic of)