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IRCT20230626058586N6 IRCT 2024-10-13 Shahid Beheshti University of Medical Sciences The effect of glutamine on muscle mass Investigating the effect of glutamine supplementation on the Rectus Femoris and Vastus Intermedius mascles thinckness in patients undergoing laparoscopic sleeve gastrectomy 2025-01-20 anticipated 30 Complete https://irct.ir/trial/79485 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The website www.Randomization.com will be used for randomization (online randomization). After determining the number of intervention groups, which are two groups, and the required number in each of these groups, the website will provide us with a random table of numbers that will represent the patient's number. Then the random sequence is available to the researcher. The researcher performs the desired intervention based on the order in which the participants entered the study, Blinding description: Glutamine supplement and placebo will be labeled by a third person in similar packages with the names A and B and will be provided to the patient by a blinded researcher. The researcher and the patient will be unaware of the content of the supplement. N/A Decreased muscle mass. Intervention 1: Intervention group: Patients undergoing laparoscopic gastrotomy who consume 30 grams of glutamine powder daily for 8 weeks 10 days after surgery. Intervention 2: Control group: Patients undergoing laparoscopic gastrotomy who take 30 grams of Maltodextrin powder a day for 8 weeks 10 days after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Naser Malekpour Alamdari
Shahid Modarres Hospital, Saadat Abad Blvd.
Tehran Iran (Islamic Republic of) 1199465222 +98 912 824 6152 Nassermalekpour@gmail.com Shahid Beheshti University of Medical Sciences scientific Naser Malekpour Alamdari
Shahid Modarres Hospital, Saadat Abad Blvd.
Tehran Iran (Islamic Republic of) 1199465222 +98 912 824 6152 Nassermalekpour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients in the age range of 20-64 BMI ≥40 before surgery 20 years 64 years Both The presence of other conditions that can affect muscle mass, such as myopathies Presence of concurrent severe underlying disease Using drugs that can affect muscle mass, such as corticosteroids Active abuse of drugs or alcohol Lack of consent to participate in the study Patients who undergo bariatric surgery for the second time M70 Soft tissue disorders related to use, overuse and pressure Prevention Prevention Intervention group: Patients undergoing laparoscopic gastrotomy who consume 30 grams of glutamine powder daily for 8 weeks 10 days after surgery Control group: Patients undergoing laparoscopic gastrotomy who take 30 grams of Maltodextrin powder a day for 8 weeks 10 days after surgery. Reduction of Vastus Intermedius and Rectus Femoris muscle mass, which will be measured by ultrasound. Timepoint: Measurement of Vastus Intermedius and Rectus Femoris muscle mass by ultrasound before gastrotomy surgery and 8 weeks after surgery. Method of measurement: Muscle mass will be measured by SuperSonic ® MACHTM20 ultrasound. Shahid Beheshti University of Medical Sciences Approved 2024-08-18 Ethics Committee of Shahid Beheshti University of Medical Sciences Ethics Committee of Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Velenjak st., Tehran. Tehran Tehran Iran (Islamic Republic of)