Investigating the effect of glutamine supplementation on the Rectus Femoris and Vastus Intermedius mascles thinckness in patients undergoing laparoscopic sleeve gastrectomy
Investigating the effect of glutamine supplementation on muscle mass changes in Rectus Femoris and Vastus Intermedius muscles in patients undergoing laparoscopic sleeve gastrectomy.
Design
This clinical trial has a control group with parallel groups, double-blind, where patients and researchers will be unaware of the type of intervention, randomized online and through the website www.randomization.com, without phase and on 30 patients under laparoscopic sleeve surgery will be performed.
Settings and conduct
The study will be conducted in the surgical department of Shahid Modares Hospital. Patients referred for laparoscopic sleeve after surgery will receive glutamine supplement or placebo in the same packaging labeled A and B. Labeling will be done by a third person and the researcher and patient will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age 64-20
2. BMI≥40 before surgery
exclusion criteria:
1. Existence of conditions that can affect muscle mass, such as myopathy.
2. Existence of simultaneous severe pathology
3. Using drugs that can affect muscle mass, such as corticosteroids
4. Active abuse of drugs or alcohol
5. Lack of consent to participate in the study
6. The patient has already undergone bariatric surgery
Intervention groups
Intervention group: 15 patients who will take glutamine for 8 weeks after surgery.
Control group: 15 patients who will receive placebo for 8 weeks after surgery.
Main outcome variables
Decrease in muscle mass of rectus femoris and vastus intermedius muscles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230626058586N6
Registration date:2024-10-13, 1403/07/22
Registration timing:prospective
Last update:2024-10-13, 1403/07/22
Update count:0
Registration date
2024-10-13, 1403/07/22
Registrant information
Name
Nasim Sohrabifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 229 6766
Email address
nasimsohrabifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of glutamine supplementation on the Rectus Femoris and Vastus Intermedius mascles thinckness in patients undergoing laparoscopic sleeve gastrectomy
Public title
The effect of glutamine on muscle mass
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age range of 20-64
BMI ≥40 before surgery
Exclusion criteria:
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
Age
From 20 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Ethics Committee of Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Velenjak st., Tehran.
City
Tehran
Province
Tehran
Postal code
1995825466
Approval date
2024-08-18, 1403/05/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.237
Health conditions studied
1
Description of health condition studied
Decreased muscle mass
ICD-10 code
M70
ICD-10 code description
Soft tissue disorders related to use, overuse and pressure
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing laparoscopic gastrotomy who consume 30 grams of glutamine powder daily for 8 weeks 10 days after surgery
Category
Prevention
2
Description
Control group: Patients undergoing laparoscopic gastrotomy who take 30 grams of Maltodextrin powder a day for 8 weeks 10 days after surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Dr. Naser Malekpour Alamdari
Street address
Shahid Modarres Hospital, Saadat Abad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 824 6152
Email
Nassermalekpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Naser Malekpour Alamdari
Street address
Shahid beheshti University of medical sciences Research Vice-Chancellor, Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjoo Blvd., Volenjak St., Tehran.
City
Tehran
Province
Tehran
Postal code
199852468
Phone
+98 21 2387 1524
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Naser Malekpour Alamdari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Saadat Abad Blvd.
City
Tehran
Province
Tehran
Postal code
1199465222
Phone
+98 912 824 6152
Email
Nassermalekpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Naser Malekpour Alamdari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Saadat Abad Blvd.
City
Tehran
Province
Tehran
Postal code
1199465222
Phone
+98 912 824 6152
Email
Nassermalekpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Naser Malekpour Alamdari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Saadat Abad Blvd.
City
Tehran
Province
Tehran
Postal code
1199465222
Phone
+98 912 824 6152
Email
Nassermalekpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available