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IRCT20110811007297N6 IRCT 2020-01-17 Fasa University of Medical Sciences Comparing the effects of aerobic exercises and low-calorie diet on insulin resistance Comparing the effects of aerobic exercises and low-calorie diet on inflammation and insulin resistance, a randomized clinical trial 2019-05-05 anticipated 90 Complete https://irct.ir/trial/41088 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization for individuals (18 blocks with equal size of 5, non-stratified); randomization tool: table of random digits generated using Microsoft Excel software; allocation concealment: sequentially numbered sealed opaque envelopes which included groups' codes (according to the table of random digits). The secretary of ward will take an envelop (according to the sequence of referred patient). Then, patient's first name (to save patients' confidentiality) will be written on the envelop. Now, it will be opened and patient's group will be determined accordingly, Blinding description: data collectors, outcome assessors, and bio-statistician. N/A People with overweight and obesity. Intervention 1: First intervention group: special diet that provides 500 calories less than the TEE (including 50-50% carbohydrate, 15-20% protein and 30-25% fat), totally 3500 per week. Intervention 2: Second intervention group: performed moderate exercise (60-75% of the maximum heart rate). Exercise for these people started at 90 minutes a week, was divided into three doses, and the heart rate was monitored through a monitor on the device. Duration of the session (10-15 minutes for each session) and the number of training sessions (started three times a week and reached seven sessions per week) was increased, at the end of intervention each person had an average of 200-300 minutes per week aerobic exercise in his program, equivalent to the 1400-2100 MET (3500 kcal/week). Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: Along with published article and for ever. To whom: People working in academic institutions Conditions: There is no restriction on this matter. Requests will be reviewed by corresponding author. Where to obtain: Professor Reza Homayounfar via his email: homayounfar@sbmu.ac.ir How to obtain: Researchers should email their request and their topic of researches. Response will be available within 7 working days. Comments:
public Reza Homayounfar
Fasa University of Medical Sciences
Fasa Iran (Islamic Republic of) 7135644144 +98 21 8670 5503 r_homayounfar@yahoo.com Fasa University of Medical Sciences scientific Reza Homayounfar
Fasa University of Medical Sciences
Fasa Iran (Islamic Republic of) 7135644144 +98 21 8670 5503 r_homayounfar@yahoo.com Fasa University of Medical Sciences Iran (Islamic Republic of) no constant physical activity BMI above 25 35 years 50 years Male those with metabolic problems and diseases including thyroid disease, cancer, lipid profile problems, blood sugar, blood pressure, liver and kidney diseases those who used any special diet or had changed their diet over the past six months E66 Overweight and obesity Lifestyle Lifestyle First intervention group: special diet that provides 500 calories less than the TEE (including 50-50% carbohydrate, 15-20% protein and 30-25% fat), totally 3500 per week. Second intervention group: performed moderate exercise (60-75% of the maximum heart rate). Exercise for these people started at 90 minutes a week, was divided into three doses, and the heart rate was monitored through a monitor on the device. Duration of the session (10-15 minutes for each session) and the number of training sessions (started three times a week and reached seven sessions per week) was increased, at the end of intervention each person had an average of 200-300 minutes per week aerobic exercise in his program, equivalent to the 1400-2100 MET (3500 kcal/week) Leptin, adiponectin, Chemerin, FBS, fasting insulin, insulin resistance index (HOMA-IR), hs CRP inflammatory index, interleukin 1β, and interleukin-6. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Blood sample. Fasa University of Medical Sciences Approved 2019-07-10 Fasa University of Medical Sciences Fasa University of Medical Sciences . Ethics department Fasa Fars Iran (Islamic Republic of)