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IRCT20200729048246N1 IRCT 2020-08-21 Shahid Beheshti University of Medical Sciences Response of metabolic parameters to 4 weeks of High Intensity Interval Training (HIIT) Improved fatty liver index- induced high-intensity interval training associated with decrease liver enzyme plasma levels and metabolic parameters in type 2 diabetes 2019-05-01 anticipated 70 Complete https://irct.ir/trial/50030 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Using a computer and simple randomization. The software randomly selects numbers between 1 and 0 and numbers less than 0.5 will be in the control group and numbers greater than 0.5 will be in the intervention group. Finally, 40 subjects will be divided into two groups, Blinding description: Subjects were coded instead of using their names. From an uninformed person Was asked to randomly distribute the codes. Study groups instead The group name had a code. Laboratory of the names of groups and participants was informed and used codes. Codes were also used for statistical analysis. N/A Type 2 diabetes. Intervention 1: All of the participants conducted supervised HIIT on cycling ergometer (894E Monark Ergomedic Peak Bike, Varberg, Sweden) three sessions per week for 4- weeks. Each session of HIIT consisted of 4-intervals (1 min) at 80% maximal heart rate (HRmax) separated by 4 min at 70% HRmax. Each training session was start by 5 min of warm-up, which including walking, running and stretching movements at 40% HRmax. The participants ended the session of exercise training with 5 min at 40% HRmax as cool-down. To ensure appropriate intensity, all patients wore a heart rate monitor (Polar Beat, Polar Electro) during each exercise session. Intervention 2: Control group: The subjects in this group will not have any regular exercise and will only use the usual treatments for type 2 diabetes. Yes - There is a plan to make this available What will be shared: Data of research dependent variables can be coded without the name of the subject Release When: The article will be available after submission To whom: researchers Conditions: The data are available for re-analysis by researchers Where to obtain: Author. How to obtain: The request should be sent by email to the responsible author. Comments:
public Dr Saeed Kalbasi
Kargar South Kamali St. Loghman Hakim Medical and Educational Center Clinical Research Development Center
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5541 9005 Saeed-Kalbasi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Saeed Kalbasi
Kargar South Kamali St. Loghman Hakim Medical and Educational Center Clinical Research Development Center
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5541 9005 Saeed-kalbasi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetic patients of Loghman Hakim Hospital A1C more than 6% Lack of Orthopedic diseases Age limit (45 to 60 years) male and female lack of neuromuscular disease lack of Nephropathy lack of Hypertension lack of Myocardial infarction lack of Bypass surgery 45 years 60 years Both Orthopedic diseases neuromuscular disease Nephropathy Hypertension Myocardial infarction Bypass surgery Type 2 diabetes Lifestyle Treatment - Drugs All of the participants conducted supervised HIIT on cycling ergometer (894E Monark Ergomedic Peak Bike, Varberg, Sweden) three sessions per week for 4- weeks. Each session of HIIT consisted of 4-intervals (1 min) at 80% maximal heart rate (HRmax) separated by 4 min at 70% HRmax. Each training session was start by 5 min of warm-up, which including walking, running and stretching movements at 40% HRmax. The participants ended the session of exercise training with 5 min at 40% HRmax as cool-down. To ensure appropriate intensity, all patients wore a heart rate monitor (Polar Beat, Polar Electro) during each exercise session. Control group: The subjects in this group will not have any regular exercise and will only use the usual treatments for type 2 diabetes. Liver enzyme plasma levels. Timepoint: 24 hours before the intervention period and 48 hours after the intervention period. Method of measurement: ELISA. Fatty liver index. Timepoint: 24 hours before the intervention period and 48 hours after the intervention period. Method of measurement: Fatty liver index (FLI) is a non-invasive method for assessing hepatic steatosis which calculated by following formula: FLI= (e 0.953 × loge (triglycerides) + 0.139 × BMI + 0.718 × loge (GGT) + 0.053 × waist circumference – 15.745)/ (1 + e 0.953 × loge (triglycerides) + 0.139 × BMI + 0.718 × loge (GGT) + 0.053 × waist circumference – 15.745) × 100. The FLI was calculated in each subjects. Lipid profile. Timepoint: 24 hours before the intervention period and 48 hours after the intervention period. Method of measurement: ELISA. HbA1c. Timepoint: 24 hours before the intervention period and 48 hours after the intervention period. Method of measurement: ELISA. Renal function, measurement of urea and creatinine. Timepoint: 24 hours before the intervention period and 48 hours after the intervention period. Method of measurement: Quantified by photometry. Shahid Beheshti University of Medical Sciences Approved 2019-09-01 The ethics committee of Loghman Hakim clinical research development center Kargar South Kamali St. Loghman Hakim Medical and Educational Center Clinical Research Development Center Tehran Tehran Iran (Islamic Republic of)