Protocol summary

Study aim
Determining the effect of resistance training with and without blood flow restriction on the serum levels of asprosin and TNF-α in patients with type 2 diabetes.
Design
A clinical trial with a control group, factorial, randomized with random computer software
Settings and conduct
At first, the blood samples of the people in the three groups will be taken by a specialized expert before the start of the first day of training in fasting conditions. The participants in the two groups of resistance training with and without blood flow restriction will have three training sessions per week, and then in At the end of the intervention, blood sampling will be repeated again under the same conditions as the pre-test.
Participants/Inclusion and exclusion criteria
45 men with type 2 diabetes/age 40 to 60 years old, no insulin use, no history of exercise in the past year, no regular participation in exercises, muscle damage and knee and hip joint damage, heart disease and high blood pressure
Intervention groups
resistance training group with blood flow restriction where people will have the usual and traditional way of training, resistance training group without blood flow restriction where people will train using pressure, control group of people who will not receive any exercise.
Main outcome variables
Asprosin serum level TNF-α serum level fat percentage

General information

Reason for update
Acronym
type 2 diabetes
IRCT registration information
IRCT registration number: IRCT20240622062207N1
Registration date: 2024-06-27, 1403/04/07
Registration timing: prospective

Last update: 2024-06-27, 1403/04/07
Update count: 0
Registration date
2024-06-27, 1403/04/07
Registrant information
Name
Negin Abbaszadeh Bazzi
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 3605
Email address
neginabbaszadeh@pgs.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-03, 1403/04/13
Expected recruitment end date
2024-08-03, 1403/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistance training with and without blood flow restriction on the serum levels of Aspersion and TNF-α in patients with type2 diabetes
Public title
Investigating the effect of resistance training with and without blood flow restriction in type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 60 years Not taking insulin No history of sports activity in the past year
Exclusion criteria:
Lack of regular participation in exercises Muscle damage and knee and hip joint damage Having heart disease and high blood pressure
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
by computer random selection program
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
Working Group/Committee of Ethics in Research of University of Sistan and Baluchistan
Street address
University blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Approval date
2023-11-14, 1402/08/23
Ethics committee reference number
IR.USB.REC.1402.022

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Asprosin serum level
Timepoint
Before the start of the intervention/16 weeks after the start of the intervention
Method of measurement
Measuring asprosin concentration by ELISA method

Secondary outcomes

1

Description
TNF-α serum level
Timepoint
Before the start of the intervention/16 weeks after the start of the intervention
Method of measurement
Using the ELISA method

2

Description
fat percentage
Timepoint
Before the start of the intervention/16 weeks after the start of the intervention
Method of measurement
Using the wind composition device

Intervention groups

1

Description
Intervention group: Intervention group: resistance group with blood flow restriction
Category
Prevention

2

Description
Intervention group: Intervention group: resistance group without blood flow restriction
Category
Prevention

3

Description
Control group: Control group: no training group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital, Zahedan
Full name of responsible person
Dr.Shila Nayebifar
Street address
University blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6766
Email
shila_nayebifar@ped.usb.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Dr.Shila Nayebifar
Street address
University blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6766
Email
shila_nayebifar@ped.usb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Sistan and Baluchestan
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
University of Sistan and Baluchestan
Full name of responsible person
Negin Abbaszadeh Bazzi
Position
Master's student in sports physiology and health
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
26Zlborz Street,Zahedan,Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817964191
Phone
+98 54 3328 3605
Email
neginabbaszadeh@pgs.usb.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Dr.Nayebifar
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiology
Street address
University blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6766
Email
shila_nayebifar@ped.usb.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Negin Abbaszadeh Bazzi
Position
Master's student in sports physiology and health
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
26Zlborz Street,Zahedan,Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817964191
Phone
+98 54 3328 3605
Email
neginabbaszadeh@pgs.usb.ac.ir

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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Subjects' information will be provided to other researchers after de-identification
When the data will become available and for how long
After the publication of the final research report
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Citing the findings by citing the source
From where data/document is obtainable
Negin Abbaszadeh Bazzi neginabbaszadeh@pgs.usb.ac.ir
What processes are involved for a request to access data/document
The request will be sent to the given postal address or Nagin Abbaszadeh Bazzi email, and the data will be sent after the approval of the research team members.
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