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IRCT20221120056548N4 IRCT 2023-02-27 Danesh Alborz University The effect of exercise and nettle extract on type 2 diabetes The effect of 8 weeks of combined exercises and consumption of nettle extract on some renal indicators, lipid profile, insulin resistance in people with high blood pressure and type 2 diabetes 2023-02-28 anticipated 40 Complete https://irct.ir/trial/68794 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this randomization, the method of equal blocks (10 blocks of 4) was used, in which a number of intervention people and a number of comparison people are included in each block, and we assigned them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists. N/A Type 2 diabetes. Intervention 1: Intervention group: Intervention group: In the group of combined exercises (resistance-aerobic), training was about 180-190 minutes per week, 30 minutes of aerobic training and 30-40 minutes of resistance training in 3 sessions per week. In the initial sessions, after a 10-minute warm-up program, the participants walk on a treadmill for 20 minutes with an intensity of 60-70% of the maximum heart rate. In order to determine the intensity of the exercise, the maximum heart rate is calculated using the age-220 formula. After aerobic training, 5 minutes rest and then resistance training is done. In the first session, the resistance training is for getting to know and learning the correct movements, the subjects do the first week with minimal weight and a few repetitions below the maximum. From the second week onwards, after estimating the one repetition maximum (1RM). Resistance training is performed with an intensity equivalent to 60 percent of a maximum repetition with 10 repetitions per movement for 3 consecutive sets of 30 seconds rest between each station and 120 seconds rest between each round. These exercises are programmed in 10 circular movements. Stations include: chest press, shoulder press (military), underarm lat, leg press, front thigh, lying back thigh, leg pull, front arm and back arm pull-up and sit-up. It is deadlift and squat. 5 minutes are allocated for cooling down. In order to comply with the principle of overload and increase the intensity, once every 2 weeks, a maximum repetition is re-measured and 60% of it is calculated. The intervention of extract consumption in supplement and exercise + supplement groups is carried out 15 minutes before the three main meals of breakfast, lunch and dinner and daily for eight weeks. According to previous studies, the dose of nettle was considered to be 10 grams per day, and 10 grams will be divided into three parts and consumed as an extract. Nettle extract will be prepared from the essential plant pharmaceutical company. Intervention 2: Control group: They are not subject to any intervention. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: It will be available for researchers working in academic and scientific institutions. Conditions: If the intellectual rights are preserved, the data can be sent to the researchers. Where to obtain: Email address: saeidshamlou9092@gmail.com How to obtain: Submission of a written request (one week) Comments:
public Saeid Shamlou Kazemi
Mahdiyeh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3221 0929 saeidshamlou9092@gmail.com Bu-Ali Sina University scientific Saeid Shamlou Kazemi
Mahdiyeh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3221 0929 saeidshamlou9092@gmail.com Bu-Ali Sina University Iran (Islamic Republic of) Suffering from type 2 diabetes 45 years 65 years Male History of cardiovascular disease E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Intervention group: Intervention group: In the group of combined exercises (resistance-aerobic), training was about 180-190 minutes per week, 30 minutes of aerobic training and 30-40 minutes of resistance training in 3 sessions per week. In the initial sessions, after a 10-minute warm-up program, the participants walk on a treadmill for 20 minutes with an intensity of 60-70% of the maximum heart rate. In order to determine the intensity of the exercise, the maximum heart rate is calculated using the age-220 formula. After aerobic training, 5 minutes rest and then resistance training is done. In the first session, the resistance training is for getting to know and learning the correct movements, the subjects do the first week with minimal weight and a few repetitions below the maximum. From the second week onwards, after estimating the one repetition maximum (1RM). Resistance training is performed with an intensity equivalent to 60 percent of a maximum repetition with 10 repetitions per movement for 3 consecutive sets of 30 seconds rest between each station and 120 seconds rest between each round. These exercises are programmed in 10 circular movements. Stations include: chest press, shoulder press (military), underarm lat, leg press, front thigh, lying back thigh, leg pull, front arm and back arm pull-up and sit-up. It is deadlift and squat. 5 minutes are allocated for cooling down. In order to comply with the principle of overload and increase the intensity, once every 2 weeks, a maximum repetition is re-measured and 60% of it is calculated. The intervention of extract consumption in supplement and exercise + supplement groups is carried out 15 minutes before the three main meals of breakfast, lunch and dinner and daily for eight weeks. According to previous studies, the dose of nettle was considered to be 10 grams per day, and 10 grams will be divided into three parts and consumed as an extract. Nettle extract will be prepared from the essential plant pharmaceutical company. Control group: They are not subject to any intervention. The percentage of people whose blood pressure decreased. Timepoint: Measurement before and after the intervention. Method of measurement: Using a mercury pressure gauge (ALPK2) made in Japan. The percentage of people whose cholesterol, low-density lipoprotein and triglyceride levels have decreased. Timepoint: Measurement before and after the intervention. Method of measurement: By testing blood samples. Danesh Alborz University Approved 2022-06-27 Ethics Committee of Sport Sciences Research Institute Fifth Alley, Mir Emad Ave., Ostad Motahari Ave Tehran Tehran Iran (Islamic Republic of)