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IRCT20240125060808N1 IRCT 2025-03-02 University of Sistan and Baluchestan Investigating the effect of aerobic exercise with and without blood occlusion in type 2 diabetes Type 2 diabetes Investigation of TCF7L2 gene expression following aerobic exercise with and without blood occlusion in white blood cells of type 2 diabetes patients 2023-04-19 anticipated 100 Complete https://irct.ir/trial/75257 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified random selection: Patients are stratified by certain characteristics, such as age, sex, or health status, and then randomly selected from each stratum. N/A Type 2 diabetes. Intervention 1: Intervention group: low to moderate intensity treadmill running aerobic exercises with blood vessel occlusion using the Anhuma company device for 3 sessions a week for 16 weeks. Intervention 2: Intervention group: Intervention group: low to moderate intensity treadmill running aerobic exercises without blood vessel occlusion for 3 sessions a week for 16 weeks. Intervention 3: Control group: Not doing any physical activity and occlusion blood flow. No - There is not a plan to make this available Justification or reason for not sharing IPD is Undecided - It is not yet clear if there is a plan to provide access

public Mina Rigi

Nurse Blvd. between Nurse 11 and 13

Zahedan Iran (Islamic Republic of) 9816985819 +98 54 3323 0725 mina.rigi.usb@gmail.com University of Sistan and Baluchestan scientific Mina Rigi

Nurse Blvd. between Nurse 11 and 13

Zahedan Iran (Islamic Republic of) 9816985819 +98 54 3323 0725 mina.rigi.usb@gmail.com University of Sistan and Baluchestan Iran (Islamic Republic of) History of type 2 diabetes for more than one year Not consuming insulin Age 40 to 60 years 40 years 60 years Male Having a heart problem Not participating regularly in training session Smoking Not following health protocols E11 Type 2 diabetes mellitus Prevention Prevention Prevention Intervention group: low to moderate intensity treadmill running aerobic exercises with blood vessel occlusion using the Anhuma company device for 3 sessions a week for 16 weeks. Intervention group: Intervention group: low to moderate intensity treadmill running aerobic exercises without blood vessel occlusion for 3 sessions a week for 16 weeks. Control group: Not doing any physical activity and occlusion blood flow In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the primary outcome is "tcf7l2 gene (Transcription Factor 7-like 2) with the relative measure of fold unit". Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients", the time points of tcf7l2 measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel blockage in white blood cells of type 2 diabetes patients", the method of measuring the variable " real-time polymerase chain reaction. In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel blockage in white blood cells of type 2 diabetes patients" secondary outcome of fasting blood sugar in mg/dL units. Timepoint: In the study "Examination of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the time points of fasting blood sugar measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" how to measure fasting blood sugar using Delta kit and biochemistry autoanalyzer of Biotecnica brand BT3500. In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" is the secondary outcome of blood urea nitrogen with units of mg/dL. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients", the time points of blood urea nitrogen measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in the white blood cells of type 2 diabetes patients," how to measure blood urea nitrogen using the Delta Kit and the Biotecnica biochemistry autoanalyzer, model BT3500. In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" secondary outcome of blood creatinine in mg/dL unit. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" time points of blood creatinine measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blockage of blood vessels in the white blood cells of type 2 diabetes patients" how to measure blood creatinine using Delta kit and Biotecnica biochemistry autoanalyzer model BT3500. In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel blockage in white blood cells of type 2 diabetes patients" is the secondary outcome of cholesterol in mg/dL units. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel blockage in white blood cells of type 2 diabetes patients" the time points of cholesterol measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in the white blood cells of type 2 diabetes patients" How to measure cholesterol "using the Delta kit and Biotecnica biochemistry autoanalyzer model BT3500". In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" is the secondary outcome of alkaline phosphatase with units of mg/dL. Timepoint: In the study "Examination of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the time points of alkaline phosphatase measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" how to measure alkaline phosphatase" using the Delta kit and Biotecnica biochemistry autoanalyzer model BT3500". In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" is the secondary outcome of aspartate aminotransferase with the criterion of units per liter. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the time points of aspartate aminotransferase measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in the white blood cells of type 2 diabetes patients" how to measure aspartate aminotransferase" using Delta kit and Biotecnica biochemistry autoanalyzer model BT3500". In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the secondary outcome of alanine aminotransferase with the criterion of units per liter. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients", the time points of measuring alanine aminotransferase of all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in the white blood cells of type 2 diabetes patients" how to measure alanine aminotransferase using the Delta kit and Biotecnica biochemistry autoanalyzer model BT3500. In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the secondary outcome of triglycerides in mg/dL units. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel obstruction in white blood cells of type 2 diabetes patients" the time points of triglyceride measurement of all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" how to measure triglycerides using Delta kit and biochemistry autoanalyzer of Biotecnica brand BT3500. In the study "Examination of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" secondary outcome of high density lipoprotein in mg/dL unit. Timepoint: In the study "Examination of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" time points of high density lipoprotein measurement in all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" how to measure high density lipoprotein "using a biorex kit and a Biotecnica biochemistry autoanalyzer model BT3500". In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in the white blood cells of type 2 diabetes patients" is the secondary outcome of low-density lipoprotein in mg/dL units. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the time points of measuring low density lipoprotein of all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" how to measure low-density lipoprotein" using a biorex kit and Biotecnica biochemistry autoanalyzer model BT3500". In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" is the secondary outcome of glycosylated hemoglobin with percentage units. Timepoint: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" the time points of measuring glycosylated hemoglobin of all groups including the control group, the aerobic exercise group with blood flow obstruction and the aerobic exercise group without blood flow obstruction before the pre-test and 48 hours after the last exercise session at the end of the study. Method of measurement: In the study "Investigation of TCF7L2 gene expression following aerobic exercise with and without blood vessel occlusion in white blood cells of type 2 diabetes patients" how to measure glycosylated hemoglobin using Pishtaz kit and Biotecnica biochemistry autoanalyzer model BT3500. University of Sistan and Baluchestan Approved 2023-04-09 Ethics committee of Sistan and Baluchistan University (Research Ethics Committee) Zahedan, University Blvd., Central Organization of Sistan and Baluchistan University, Shahid Qasim Mir Hosseini Building Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)