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IRCT20090203001640N17 IRCT 2020-05-20 Shahid Beheshti University of Medical Sciences Effect of legumes consumption in patients with type 2 diabetes TLGS Effect of substitution of meat with legumes in the dietary approach to stop hypertension diet on lipid profile, indices of glycemic, inflammation, coagulation, and oxidative stress in patients with type 2 diabetes according to genotype of rs7903146 in the TCF7L2 2020-07-05 anticipated 300 Complete https://irct.ir/trial/46855 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups Participants were randomly assigned to intervention or control group in the random blocks based on the random number table.The sequence of permuted blocks was generated with a random number table. An individual with no clinical involvement in the trial, put the lable of intervention or control group in an opaque and sealed envelope based on the random sequence. Then the other person, who was not aware of random sequences and the envelope content, assigned the patients to the intervention or control group, Blinding description: This study is designed as a single blind study. The main investigator and outcome assessor are not aware of each patient's treatment assignment and the main investigator is not involved in the randomization process. 3 Condition 1: Type 2 diabetes. Condition 2: overweight and obesity. Intervention 1: Intervention group: Legume based dietary approach to stop hypertension diet with weight reduction. Intervention 2: Control group: Dietary approach to stop hypertension diet with weight reduction. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: 2 months after publication To whom: People working in academic institutions Conditions: The data is provided for systematic review at the request of the researcher Where to obtain: Data should be requested from Dr. Parvin Mirmiran via mirmiran@endocrine.ac.ir. How to obtain: The applicant must provide a confirmation letter from the head of the center asking for the data Comments:
public Somayeh Hosseinpour
No. 24, Aarabi St, Yeman St, Velenjak
Tehran Iran (Islamic Republic of) 19395-4763 +98 21 2243 2500 s.hossainpour@yahoo.com Shahid Beheshti University of Medical Sciences scientific Somayeh Hosseinpour
No. 24, Aarabi St, Yeman St, Velenjak
Tehran Iran (Islamic Republic of) 19395-4741 +98 21 2243 2500 s.hossainpour@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Agreement to participate in the study and completing informed consent form Fasting blood glucose ≥126 mg/dl or 2-h plasma glucose ≥200 mg/dl or treatment with anti-hyperglycemic medications Aged 35-65 years old Body mass index between 25-40 kg/m2 No weight change in past three months determining transcription factor-7-like 2 rs7903146 genotypes 30 years 65 years Both Cardiovascular disease such as myocardial infarction in past 6 months Renal disease (creatinine 1.4 ≥ mg/dl for men or ≥1.3 mg/dl for women) Alcohol intake, either acute or chronic Using anti inflammatory drugs Following any specific diet in past three months Gastrointestinal disease (e.g. inflammatory bowel diseases) lower desire or lack of desire to consume legumes Insulin treatment Pregnant and lactating women E08 E66 Diabetes mellitus due to underlying condition Overweight and obesity Treatment - Other Treatment - Other Intervention group: Legume based dietary approach to stop hypertension diet with weight reduction Control group: Dietary approach to stop hypertension diet with weight reduction Fasting plasma glucose. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method. High sensitive C reactive protein. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: ELISA. Plasma concentration of total cholesterol. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method. Plasma concentration of low density lipoprotein cholesterol. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method. Plasma concentration of high density lipoprotein cholesterol. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method. Plasma triglyceride concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method. Tumor necrosis factor alpha concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay. Interleukin 6. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay. Fibrinogen concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Turbiditymeter. Plasma catalase activity. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Catalase activity assay kit. Plasma insulin concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay. Total antioxidant capacity. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Colorimetric. Malondialdehyde concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Colorimetric. Systolic blood pressure. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Mercury sphygmomanometers. Diastolic blood pressure. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Mercury sphygmomanometers. Weight. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Scales. Shahid Beheshti University of Medical Sciences Approved 2020-05-12 ethics committee of the Research Institute for Endocrine Sciences, Shahid Beheshti University of Med No 24, A’rabi St, Yeman Av, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)