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IRCT20180923041097N2 IRCT 2020-07-16 University of Sistan and Baluchestan Effect of Combined Training Course and Aloe Vera supplement on Renal Function and Lipid Profile of Patients with Type 2 Diabetes Effect of Combined Training Course and Aloe Vera supplement on Renal Function and Lipid Profile of Patients with Type 2 Diabetes 2019-09-23 anticipated 36 Complete https://irct.ir/trial/43650 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation method was performed in the form of blocks with predetermined sizes so that the subjects were divided into equal numbers in the research groups in such a way that each subject was assigned a code and then based on a lottery were placed in research groups, Blinding description: One of the Experimental groups of the study was the Exercise+Supplement group, which received the supplement in the form of a capsule along with the Exercise, and the second Experimental group was the Exercise group, which only exercised, and a capsule that looks like a supplement but contains It was Starch, it received. N/A Type 2 diabetes. Intervention 1: Control group: The subjects in this group did not do any exercise during the research period (6 weeks) and did not receive any supplements. Intervention 2: The second intervention group was the exercise group that during the research period (6 weeks, 3 days per week and 50-60 minutes every day), only did exercise. Combined exercise includes resistance exercises (2 turns of 12 repetitions of special resistance exercises for large muscle groups with an intensity of 70% of 1RM. Rest time between turns was 2 minutes) and aerobic exercise (2 turns of 10-minute runs with 70-75% of maximum heart rate on a treadmill). A polar heart rate monitor was used to control the desired heart rate. It is noteworthy that the exercises training took place from 5 to 6 p.m. Subjects performed static stretching and flexion movements before and after each training session to warm and cool the body. Intervention 3: Third intervention group: Exercise + supplement group. Subjects in this group performed combined exercises with the exercise group and, in addition, received 500 mg/day of aloe vera supplement (manufactured by Supernatural Canada) for 6 weeks during the study period. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared. When: Possibility to access 05 months after printing the results. To whom: Researchers in academic institutions and industry Conditions: No special conditions are considered Where to obtain: Email address How to obtain: There is no specific process. Comments:
public Reza Delavar
Department of Sports Sciences, Sistan and Baluchestan University, University Street.
Zahedan Iran (Islamic Republic of) 9816745845 +98 54 3113 2674 delavar@ped.usb.ac.ir Sistan and Baluchestan University scientific Reza Delavar
Department of Sports Sciences, Sistan and Baluchestan University, University Street.
Zahedan Iran (Islamic Republic of) 9816745845 +98 54 3113 2674 delavar@ped.usb.ac.ir University of Sistan and Baluchestan Iran (Islamic Republic of) Criteria for inclusion in the study: - male gender. - Having type 2 diabetes as diagnosed by a doctor. - Age 40 to 60 years old. - Physical strength required to attend a exercise protocol for 2 months. 40 years 60 years Male Criteria for non-inclusion in the study were: - cardiovascular disease. - Asthma. - having a history of broken limbs. - The use of insulin. - complications of diabetes, including diabetic foot ulcers. E11.2 Type 2 diabetes mellitus with kidney complications Other Other Other Control group: The subjects in this group did not do any exercise during the research period (6 weeks) and did not receive any supplements. The second intervention group was the exercise group that during the research period (6 weeks, 3 days per week and 50-60 minutes every day), only did exercise. Combined exercise includes resistance exercises (2 turns of 12 repetitions of special resistance exercises for large muscle groups with an intensity of 70% of 1RM. Rest time between turns was 2 minutes) and aerobic exercise (2 turns of 10-minute runs with 70-75% of maximum heart rate on a treadmill). A polar heart rate monitor was used to control the desired heart rate. It is noteworthy that the exercises training took place from 5 to 6 p.m. Subjects performed static stretching and flexion movements before and after each training session to warm and cool the body. Third intervention group: Exercise + supplement group. Subjects in this group performed combined exercises with the exercise group and, in addition, received 500 mg/day of aloe vera supplement (manufactured by Supernatural Canada) for 6 weeks during the study period. Blood creatinine, The normal level of creatinine is 0.8 to 1.4 mg/dL. Females usually have a lower creatinine (0.6 to 1.2 mg/dL) than males, because they usually have less muscle mass. Creatinine is a by-product of normal muscle breakdown. Measuring the levels of creatinine in the bloodstream and in the urine can be helpful for tracking the progression of diabetic kidney disease. Timepoint: Primary blood sampling was performed 24 hours before the start of exercise training protocol and final stage blood sampling was performed 48 hours after the last exercise training session. Method of measurement: To measure serum creatinine, a technical creatinine assay kit made by Pars Azmoun Company, Iran, was used. Diabetes is associated with quantitative changes in the amount of circulating lipids – notably an reduction in HDL. Like other lipoproteins, HDL also undergoes significant qualitative changes in diabetes, in both structure and function. Timepoint: Measurement of serum lipoprotein HDL was performed in two stages, the first stage in the initial blood sampling, ie 24 hours before the start of exercise training protocol and the second stage in the final stage blood sampling, ie 48 hours after the last exercise session. Method of measurement: To measure the concentration of HDL index (mg / dL), deposition method with bridging anions and divalent cations was used. LDL cholesterol levels in people with diabetes are not higher than those in people without diabetes who are matched for age, sex, and body weight. In fact, the most common LDL cholesterol level in diabetes is “borderline high” (130-159 mg/dl). Timepoint: Measurement of serum lipoprotein LDL was performed in two stages, the first stage in the initial blood sampling, ie 24 hours before the start of exercise training protocol and the second stage in the final stage blood sampling, ie 48 hours after the last exercise session. Method of measurement: The Friedwall equation was used to measure the concentration of LDL (mg / dL). Lipid abnormalities in patients with diabetes,that termed “diabetic dyslipidemia”, are typically characterized by high triglyceride (Tg). Timepoint: Measurement of serum TG was performed in two stages, the first stage in the initial blood sampling, ie 24 hours before the start of exercise training protocol and the second stage in the final stage blood sampling, ie 48 hours after the last exercise session. Method of measurement: Triglyceride index concentration (mg / dL) was measured enzymatically using a technical triglyceride assay kit made by Pars Azmoun and AutoAnalyzer (1000RA). Determines of kidney disease level based on the presence of kidney damage and glomerular filtration rate (GFR), which is a measure of level of kidney function, as chronic kidney disease progresses, GFR number decreases. Timepoint: The calculation of glomerular filtration of the subjects was done in two stages, the first stage in the initial blood sampling, ie 24 hours before the start of exercise training protocol and the second stage in the final stage blood sampling, ie 48 hours after the last exercise session. Method of measurement: Glomerular filtration rate (GFR) was also calculated from the following formula. eGFR = [186 × (serum creatinine / 88.4) - 1.154] × (age) - 0.203 × (0.742). University of Sistan and Baluchestan Approved 2019-03-10 Ethics committee of Zahedan University of Medical Sciences Daneshgah Street, University of Sistan and Baluchestan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)