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IRCT20201128049510N1 IRCT 2022-12-07 University of Mohaghegh Ardabili The effect of exercise and Mulberry leaf extract on some cardiovascular inflammatory markers in the elderly with type 2 diabetes - The effect of combined exercises and the consumption of Mulberry leaf extract on the serum levels of alpha and beta salucin and some related inflammatory or cardiovascular markers in elderly men with type 2 diabetes 2022-11-17 anticipated 40 Complete https://irct.ir/trial/66892 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, the subjects are selected by simple random with the rule of random allocation. Thus, after determining the sample size, people will be equally placed in five groups (1-exercise, 2-exercise+supplement, 3- supplement, 4- placebo and 5- control). Using the lottery method, the names of the subjects are written on separate papers and placed in a container. Then the names of the subjects will be taken out randomly and they will be placed in the intervention, placebo and control groups respectively. 3 Type 2 diabetes. Intervention 1: Intervention group: Intervention group 1: Combined exercise (aerobic and resistance): Aerobic exercises will be performed for 10 to 30 minutes with an intensity between 50 and 70% of the maximum heart rate. Resistance exercises for 30 to 40 minutes with an intensity between 40 and 70 percent of a maximum repetition will be performed by the subjects. Intervention 2: Intervention group: Intervention group 2: Supplement group + daily exercise will consume 1000 mg (2 capsules of 500 mg), Mulberry leaf extract , 3 times a day along with combined exercises. Intervention 3: Intervention group: Intervention 3: The daily supplement group will take 1000 mg (2 capsules of 500 mg) of Mulberry leaf extract, 3 times a day. Intervention 4: Intervention group: Intervention 4: The placebo group will take 1000 mg daily (2 capsules of 500 mg), containing wheat flour, 3 times a day. Intervention 5: Control group: The control group will not participate in any exercise program. Yes - There is a plan to make this available What will be shared: The personal data of the study participants can be shared after de-identification When: Three months after the results are published To whom: researchers Conditions: In order to be more transparent and under the consent of the researcher Where to obtain: Mohammad Ebrahim Bahram How to obtain: Request and send to the researcher Comments:
public Roghayyeh Afroundeh
Ardabil, University Street, University of Mohaghegh Ardabili
Ardabil Iran (Islamic Republic of) 8599156189 +98 45 3150 5193 afroundeh@uma.ac.ir University of Mohaghegh Ardabili scientific Roghayyeh Afroundeh
Ardabil, University Street, University of Mohaghegh Ardabili
Ardabil Iran (Islamic Republic of) 5619911367 +98 45 3150 5626 afroundeh@uma.ac.ir University of Mohaghegh Ardabili Iran (Islamic Republic of) Having type 2 diabetes between one and 10 years Not taking more than one type of oral anti-diabetic pill at night Having a basic level of glycosylated hemoglobin between 6.6 and 9.9% Having a fasting blood glucose of 160 to 250 mg/dL Ability to do sports Not participating in a regular exercise program for at least 6 months before the start of the study 60 years 70 years Male Taking more than one type of oral anti-diabetic pill at night Smoking having cardiovascular, kidney and eye diseases, complications of diabetes (neuropathy, nephropathy, retinopathy) Treated with insulin E11 Type 2 diabetes mellitus N/A N/A N/A N/A N/A Intervention group: Intervention group 1: Combined exercise (aerobic and resistance): Aerobic exercises will be performed for 10 to 30 minutes with an intensity between 50 and 70% of the maximum heart rate. Resistance exercises for 30 to 40 minutes with an intensity between 40 and 70 percent of a maximum repetition will be performed by the subjects. Intervention group: Intervention group 2: Supplement group + daily exercise will consume 1000 mg (2 capsules of 500 mg), Mulberry leaf extract , 3 times a day along with combined exercises. Intervention group: Intervention 3: The daily supplement group will take 1000 mg (2 capsules of 500 mg) of Mulberry leaf extract, 3 times a day. Intervention group: Intervention 4: The placebo group will take 1000 mg daily (2 capsules of 500 mg), containing wheat flour, 3 times a day. Control group: The control group will not participate in any exercise program. Salusin alpha. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. Salusin beta. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. Lipocalin 2. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. Galectin 3. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. Interleukin 6. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. Interleukin 1 beta. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. Insulin. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. Glucose. Timepoint: 24 hours before and 48 hours after training. Method of measurement: Blood sampling and using a laboratory kit. University of Mohaghegh Ardabili Approved 2022-04-25 Ethics Committee of Mohaghegh Ardabili University, Faculty of Educational Sciences and Psychology Ardabil, University Street, University of Mohaghegh Ardabili Ardabil Ardabil Iran (Islamic Republic of)