The effect of resistance training with and without blood flow restriction on the serum levels of sirtuin1 and nitric oxide in patients with type2 diabetes
Determining the effect of resistance training with and without blood flow restriction on the serum levels of sirtuin 1 and nitric oxide 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
Inclusion criteria: 45 men with type 2 diabetes aged 40 to 60 years, not taking insulin, and not exercising in the past year.
Exclusion criteria: regularly participating in exercises, muscle damage and knee and hip joint damage, having 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 and control group of people who will not receive any exercise.
Main outcome variables
Serum level of sirtuin 1; serum level of nitric oxide; blood pressure level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241004063256N1
Registration date:2024-11-24, 1403/09/04
Registration timing:prospective
Last update:2024-11-24, 1403/09/04
Update count:0
Registration date
2024-11-24, 1403/09/04
Registrant information
Name
Mahdiyeh Fatehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3351 8210
Email address
mahdiyehfatehi2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-01-04, 1403/10/15
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 sirtuin1 and nitric oxide in patients with type2 diabetes
Public title
Investigating the effect of resistance training with and without blood flow restriction in type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 60 years
History of type 2 diabetes for more than one yaer
Not consuming insulin
No history of sports activity in the past year
Exclusion criteria:
Having heart disease and high blood pressure
Smoking
Not participating regularly in training session
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
The number of 45 diabetic patients eligible to participate in the study by non-probability sampling method (easy and accessible) and based on the purpose of selection and randomly divided into three equal groups: resistance training with blood flow restriction, resistance training without blood flow restriction and control will be divided. A table of random numbers will be used for randomization.
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
Group work/ Ethics committee in research of University of Sistan and Baluchistan
Street address
Daneshgah 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.1402.023
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
Serum level of sirtuin 1
Timepoint
Before the start of the intervention/16 weeks after the start of the intervention
Method of measurement
Measurement of sirtuin 1 concentration by ELISA method
Secondary outcomes
1
Description
Serum nitric oxide levels
Timepoint
Before the start of the intervention/16 weeks after the start of the intervention
Method of measurement
Using the ELISA method
2
Description
Blood pressure measurement
Timepoint
before and after each training session regularly during 16 weeks of intervention
Method of measurement
Using a digital sphygmomanometer
Intervention groups
1
Description
Intervention group: resistance exercise group with blood flow restriction; This group will perform the exercises in four sets with 15, 15, 15, 30 repetitions and 20% 1RM intensity. Limitation of blood flow in the proximal part of the thigh and arm with the limiting cuff is continuously applied and during the rest between the sets, the blood flow limitation with the cuff will be removed.
Category
Prevention
2
Description
Intervention group: resistance training group without blood flow restriction; This group will perform the exercises in four sets with 8-12 repetitions and an intensity of 80% of 1RM
Category
Prevention
3
Description
Control group: This group will not receive any medicine or sports intervention and will continue their normal life.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Bin Abitalib Zahedan Hospital
Full name of responsible person
Dr. Shila Nayebifar
Street address
Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6766
Email
shila_nayebifar@ped.usb.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Sistan and Baluchistan
Full name of responsible person
Dr. Shila Nayebifar
Street address
Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6766
Email
shila_nayebifar@ped.usb.ac.ir
Grant name
Sistan and Baluchistan University Research Assistant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Sistan and Baluchistan
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 Baluchistan
Full name of responsible person
Mahdiyeh Fatehi
Position
Master's student in exercise physiology and health
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Imam Khomeini St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9818614451
Phone
+98 33518210
Email
mahdieh_fatehi@pgs.usb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Sistan and Baluchistan
Full name of responsible person
Dr. Shila Nayebifar
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiology
Street address
Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 31136766
Email
shila_nayebifar@ped.usb.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of sistan and baluchistan
Full name of responsible person
Mahdiyeh Fatehi
Position
Master's student in exercise physiology and health
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Imam Khomeini St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9818614451
Phone
+98 33518210
Email
mahdieh_fatehi@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-identificatio
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
Mahdiyeh Fatehi/ mahdiyehfatehi2@gmail.com
What processes are involved for a request to access data/document
The request will be sent to the given postal address or Mahdia Fathi's email and after the approval of the research team members, the data will be sent