evaluation of the adiponectin levels and leptin levels in obese patients 6 months after sleeve gastrectomy, bypass surgery, and SASI bypass surgery
Design
This is a non-randomized clinical trial with parallel groups. Patients are divided into three groups of 15 selected patients. Adiponectin and leptin levels are measured between patients who underwent three different obesity surgeries in Shiraz. There is no separate control group and each group undergoing surgery is compared to its preoperative one.
Settings and conduct
The place of work is Shahid Faghihi Hospital and the mother and child of Shiraz. The patient's plasma sample is collected before and after sleeve gastrectomy or bypass or SASI bypass surgery and leptin and adiponectin levels are measured by an ELISA kit. There is no blinding. The results are compared between groups.
Participants/Inclusion and exclusion criteria
obese patients who underwent bariatric surgery
Age 18-90 years old
Body Mass Index>25
Intervention groups
obese patients who underwent sleeve gastrectomy or two bypass surgeries. Adiponectin and leptin levels were assessed before and 6 months after surgery. All three groups of patients (15 people in each group) are compared to see which changes were greater.
Main outcome variables
Adiponectin levels and inflammatory factors in the patient's serum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201012049000N2
Registration date:2021-01-19, 1399/10/30
Registration timing:retrospective
Last update:2021-01-19, 1399/10/30
Update count:0
Registration date
2021-01-19, 1399/10/30
Registrant information
Name
Hajar Khazraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1453
Email address
khazraee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-02, 1398/02/12
Expected recruitment end date
2020-12-02, 1399/09/12
Actual recruitment start date
2019-05-02, 1398/02/12
Actual recruitment end date
2020-12-02, 1399/09/12
Trial completion date
2020-12-02, 1399/09/12
Scientific title
comparison the effects of Sleeve Gastrectomy, Bypass gastrectomy, and SASI bypass on the changes of adiponectin level in obese patients
Public title
comparison the effects of bariatric surgeries on the changes of adiponectin level in obese patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-90 years old
obese with BMI>25
Exclusion criteria:
past surgery history in abdominal area
endocrinological disorders
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
15
45 patients were selected from obese patients who underwent bariatric surgery
Actual sample size reached:
45
More than 1 sample in each individual
Actual sample size in each individual:
15
45 patients were selected from obese patients who underwent bariatric surgery
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Floor 9, Research tower, Khalili street, Shiraz
City
Shiraz
Province
Fars
Postal code
7193635899
Approval date
2018-02-20, 1396/12/01
Ethics committee reference number
IR.SUMS.REC.1396.S967
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Patient serum adiponectin levels
Timepoint
Before and 6 months after surgery
Method of measurement
Kit Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: obese patients under Sleeve gastrectomy surgery
Category
Treatment - Surgery
2
Description
Intervention group: obese patients under SASI surgery
Category
Treatment - Surgery
3
Description
Intervention group: obese patients under Bypass surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother and Child Hospital
Full name of responsible person
Abbas Rezaeianzadeh
Street address
Colorectal Research Center, Khalili St., Mohammad Rasoolullah Research Tower
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1453
Email
colorectal2@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
Colorectal research center, Research tower, Khalili street
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1453
Email
colorectal2@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
research proposal
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
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Khazraei
Position
Assistant prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Colorectal research center
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
009836281453
Email
khazraee@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Khazraei
Position
Assistant prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
colorectal research center
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
009836281453
Email
khazraee@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Khazraei
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
colorectal research center
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
009836281453
Email
hajarkhazraei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of patient information
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