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IRCT20230225057524N1 IRCT 2023-03-20 Kerman University of Medical Sciences Effect of aerobic exercise and astaxanthin supplementation on humanin protein expression The effect of 8 weeks of aerobic exercise and astaxanthin supplementation on humanin protein expression, miR-17, miR-146a and miR-155, and inflammatory conditions, oxidative stress and apoptosis in women with type 2 diabetes 2023-02-24 anticipated 75 Complete https://irct.ir/trial/68799 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Simple randomization method; The law of random assignment is the simplest method of limited randomization. This method represents a large block for the entire sample size, which means that the balance in the number of people assigned to each group will be achieved at the end of the study. For this purpose, the researcher first determined a total sample size, then randomly assigned groups of them to group A and the rest to group B. For example, in a study with a sample size of 200 people, 100 balls for intervention groups A and 100. The ball for intervention group B is placed in a lottery container, and then the balls are randomly removed from the container without replacement, and the created sequence is recorded, Blinding description: The participants in the design and the person who performs the data analysis are unaware of the study group assignment (which group received the supplement and which group received the placebo). N/A diabetes. Intervention 1: Intervention group 1: will receive only the interventions of 8 weeks of aerobic training (weeks one to four will be 3 sessions and weeks four to eight will be 4 sessions per week). Intervention 2: Intervention group 2: This group will receive the interventions of 8 weeks of aerobic exercise (weeks one to four will be 3 sessions and weeks four to eight will be 4 sessions per week) along with 12 mg of the base substance alone as a placebo.These ingredients will be consumed with lunch for 8 weeks. Intervention 3: Intervention group 3: This intervention group will receive 8 weeks of aerobic training (weeks one to four will be 3 sessions and weeks four to eight will be 4 sessions per week) along with subjects taking 12 mg of astaxanthin supplement daily.The content of the supplement will be astaxanthin from hematochus algae (made in the USA). These ingredients will be consumed with lunch for 8 weeks. Intervention 4: Intervention group 4: This intervention group will only receive 12 mg of astaxanthin supplement daily.The content of the supplement will be astaxanthin from hematochus algae (made in the USA). These ingredients will be consumed with lunch for 8 weeks. Intervention 5: Control group: This intervention group will only receive 12 milligrams of the basic substance as a placebo daily.These ingredients will be consumed with lunch for 8 weeks. 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: داده های شما فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود Conditions: Use in meta-analysis articles Where to obtain: To receive the desired documents or data, refer to the email of Dr. Keyvan Khorramipour. How to obtain: Six months after the time of publication of the results in a valid journal, in case of additional research work Comments:
public Keyvan Khoramipour
Kerman, Pajohesh Square
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 K.khoramipour@gmail.com Kerman University of Medical Sciences scientific Keyvan Khoramipour
Kerman, Pajohesh Square
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 K.khoramiour@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Minimum age 30 and maximum 55 years Excessive hyperglycemia (HbA1c > 10%) Diabetic microvascular complications Diabetic neuropathy Impaired liver function (plasma aminotransferase and/or g-glutamyltransferase level above the upper limit of normal for age and sex) Renal dysfunction (serum creatinine level higher than normal for age and sex) Severe anemia Uncontrolled blood pressure (blood pressure > 100/170 mm Hg) Obvious heart-related symptoms or history of cerebrovascular events Patients with cardiovascular disease (class I-IV congestive heart failure or history of myocardial infarction) Patients on insulin therapy will not be eligible Active patients who reported more than 1 exercise per week 30 years 55 years Female Patients treated with insulin Having no history of cardiovascular diseases and respiratory problems Patients who do sports. E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Treatment - Other Treatment - Other N/A Intervention group 1: will receive only the interventions of 8 weeks of aerobic training (weeks one to four will be 3 sessions and weeks four to eight will be 4 sessions per week). Intervention group 2: This group will receive the interventions of 8 weeks of aerobic exercise (weeks one to four will be 3 sessions and weeks four to eight will be 4 sessions per week) along with 12 mg of the base substance alone as a placebo.These ingredients will be consumed with lunch for 8 weeks. Intervention group 3: This intervention group will receive 8 weeks of aerobic training (weeks one to four will be 3 sessions and weeks four to eight will be 4 sessions per week) along with subjects taking 12 mg of astaxanthin supplement daily.The content of the supplement will be astaxanthin from hematochus algae (made in the USA). These ingredients will be consumed with lunch for 8 weeks. Intervention group 4: This intervention group will only receive 12 mg of astaxanthin supplement daily.The content of the supplement will be astaxanthin from hematochus algae (made in the USA). These ingredients will be consumed with lunch for 8 weeks. Control group: This intervention group will only receive 12 milligrams of the basic substance as a placebo daily.These ingredients will be consumed with lunch for 8 weeks. Percentage of women with type 2 diabetes. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Blood sugar test. Humanin serum levels. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: HN concentration will be measured by an ELISA kit [Human Peptide ELISA Kit (MT-RNR2), Baltimore, MD] with an analytical sensitivity of 7 pg/ml and a detection range of 1800-28 pg/ml. TNF-α serum levels. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: TNF-α levels will be evaluated using enzyme-linked immunosorbent assay (ELISA) following the instructions of commercial kits. The results will be presented as pg/mg of protein. IL-6 serum levels. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: IL-6 levels will be assessed using enzyme-linked immunosorbent assay (ELISA) following the instructions of commercial kits. The results will be presented as pg/mg of protein. Quantification of miR-146a. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: RT-qPCR method is used to investigate the values of miR-146a . Quantification of miR-26a. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: RT-qPCR method is used to investigate the values of miR-26a . Measurement of insulin serum levels. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Serum insulin levels will be measured by ELISA using the Mercodia Insulin Rat ELISA kit (made in Sweden) with a coefficient of variation of 2.6 and a sensitivity of 0.07 microunits per deciliter. IR-HOMA and HOMA-B index. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: It will be evaluated using the following formula HOMA-IR = (glucose in mmol/L x insulin in mIU/mL)/22.5 HOMA-B = (20 x insulin in mIU/mL)/(glucose in mmol/L – 3.5). Insulin sensitivity. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: با استفاده از شاخص QUICKI تعیین شده بر اساس معادلهQUICKI = 1/(log insulin [AIU/mL] + log glucose [mg/dL]) ارزیابی خواهد شد. شاخص QUICKI پایین نشان دهنده حساسیت کم به انسولین است، در حالی که شاخص QUICKI بالا نشان دهنده حساسیت به انسولین بالا است. Determination of serum glucose concentration. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Fasting glucose concentration will be measured using Iran's Pars test kit and calorimeter (glucose oxidase) method. Determination of BAX and BCL2 serum levels. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: To investigate the concentration of Bax and Bcl2, it will be done using the ELISA kit of Podgin Teb Company. Measurement of superoxide dismutase (SOD). Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: The amount of superoxide dismutase activity is indirectly measured using the calorimetric method based on the ability of SOD to inhibit pyrogallol autoxidation. Measurement of Glutathione Peroxidase (GPX). Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Glutathione peroxidase assay is based on the ability of glutathione peroxidase to oxidize glutathione (GSH) to oxidized glutathione (GSSH). (GSSH) is part of the reactions that reduce cumene hydroperoxide. Glutathione reductase then converts GSSH to GSH by consuming nicotinamide dinucleotide phosphate (NADPH). The reduction of NADPH measured at 340 nm is an indicator of glutathione peroxidase activity. Determination of malondialdehyde (MDA). Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: It will be determined based on the reaction with thiobarbituric acid (TBA) and using a spectrophotometric method at a wavelength of 532 nm. Measurement of total antioxidant capacity. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Antioxidant capacity is measured by LDN Germany Company kit. Kerman University of Medical Sciences Approved 2023-02-05 Kerman Medical Sciences kerman, Pajohesh Square kerman Kerman Iran (Islamic Republic of)