Protocol summary

Study aim
Correlation of selected physical activity and food consumption pattern with weight changes,with changes in body mass index (BMI) with C and T allele frequency and with UCP3 gene polymorphism in morbidly obese people after bariatric surgery
Design
The statistical population of this research includes 30 people who undergo bariatric surgery in Shiraz Hospital with the following conditions: 1- having morbid obesity, i.e. BMI = 5 ± 35 kg/m²- 2- performing bariatric surgery in Mother and Child Hospital or Hafez Shiraz 3- performing activities Physical fitness and compliance with the food consumption pattern prescribed by the surgeon for three months Three months after the bariatric operation and the determination of the new body mass index of the patients, the people who did not undergo surgery are selected as the control group.
Settings and conduct
According to the type of target, is placed in the ranks of experimental and applied research, in such a way that the effect of the independent variable (physical activity and food consumption pattern) on the dependent variable (CT/55 UCP3 gene polymorphism) is evaluated. becomes The study included peripheral blood samples, height and weight measurement and BMI calculation before the operation and three months after the bariatric operation, so the current research plan includes a pre-test and a post-test.
Participants/Inclusion and exclusion criteria
Obese people who are candidates for bariatric surgery
Intervention groups
Operated obese people: the main group People who did bariatric surgury within the newrange of body mass people: control group
Main outcome variables
Detection of obesity-related phenotypes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230225057536N1
Registration date: 2023-07-20, 1402/04/29
Registration timing: retrospective

Last update: 2023-07-20, 1402/04/29
Update count: 0
Registration date
2023-07-20, 1402/04/29
Registrant information
Name
Mahtab matin
Name of organization / entity
Zand Shiraz Institute of Higher Education
Country
Iran (Islamic Republic of)
Phone
+98 71 3650 9510
Email address
andiab1393@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Relationship of Physical Selected Activity and Food Consumption Pattern on UCP3 polymophism 55/CT Gene in People with Morbid Obesity AfterBariatric Surgery
Public title
The Relationship of Physical Selected Activity and Food Consumption Pattern on UCP3 polymophism 55/CT Gene in People with Morbid Obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Morbid obesity Bariarric surgery
Exclusion criteria:
special disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Rehabilitation Sciences
Street address
Faculty of Rehabilitation Sciences,1th Abivardi St.,Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
Approval date
2021-08-08, 1400/05/17
Ethics committee reference number
IR.SUMS.REHAB.REC1400.17

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
BMI,T&C allele
Timepoint
After bariatric surgury
Method of measurement
Scale, Amplification RefractoryMutation System(PCR-ARMS)

Secondary outcomes

1

Description
Weight
Timepoint
3 month after surgury
Method of measurement
Digital scale

Intervention groups

1

Description
Control group: People who have not had surgery
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghadir Mother and Child Superspeciality Hospital, Shiraz
Full name of responsible person
Dr. Masood Amini
Street address
Mother and Child Hospital ,at the beginning of Golshan, Above the Koran Gate
City
shiraz
Province
Fars
Postal code
Phone
+98 71 3227 9701
Email
motherhosp@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Street address
Zand Institute of Higher Education,12 Alley,At the end of Hammet South Blvd.
City
Shiraz
Province
Fars
Postal code
73489-71887
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zand Institute of Higher Education
Proportion provided by this source
100
Public or private sector
Private
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
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Zand Institute of Higher Education,12 Alley, At the end of Hammet South Blvd.
City
Shiraz
Province
Fars
Postal code
73489-71887
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Zand Institute of Higher Education,12 Alley, At the end of Hammet South Blvd.
City
Shiraz
Province
Fars
Postal code
73489-71887
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Zand Institute of Higher Education,12 Alley, At the end of Hammet South Blvd.
City
Shiraz
Province
Fars
Postal code
73489-71887
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Finding polymorphisms associated with obesity and overweight
When the data will become available and for how long
3 month after surgury
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data is only permitted for use in statistical analyses
From where data/document is obtainable
Mahtab Matin
What processes are involved for a request to access data/document
It will be emailed as soon as the request is made (it may take up to a week
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