1. Home
  2. Approved trials
  3. » فارسی

Comparisons effect of eight weeks high intensity interval training (HIIT) and continuous moderate training (CMT) on plasma levels of Calprotectin and IL-6 in type 2 diabetic persons

Protocol summary

Study aim
General purpose: Investigation of the Effect of eight weeks HIIT and CMT on plasma levels of Calprotectin and IL-6 in type 2 diabetic persons Detailed goals : 1. Investigation of the Effect of eight weeks HIIT on plasma levels of Calprotectin in type 2 diabetic persons 2. Investigation of the Effect of eight weeks CMT on plasma levels of Calprotectin in type 2 diabetic persons 3. Investigation of the Effect of eight weeks HIIT on plasma levels of IL-6 in type 2 diabetic persons 4. Investigation of the Effect of eight weeks CMT on plasma levels of IL-6 in type 2 diabetic persons 5. Compare the effects of eight weeks HIIT and CMT on plasma levels of Calprotectin and IL-6 in type 2 diabetic persons
Design
30 type 2 diabetic subjects will be divided into three groups: control, HIIT and CMT. The randomization method will be through the number table.
Settings and conduct
This research will be done in the rehabilitation department of Shahid Rajaee Hospital. Other than the researcher, none of the participants in this study will know how to assign individuals in different groups.
Participants/Inclusion and exclusion criteria
This research will have thirty type 2 diabetic people with the age of 35 to 60 and body mass between 25 to 35 kilogram / square meter as an available sample.People with cardiovascular disease, kidney and liver problems, pulmonary disease, cancer, gout, or orthopedic restrictions will be deleted. Also, subjects should not take any sporting activities two or three months before the start of the protocol
Intervention groups
control group (N=10), high intensity interval training group (N=10), and continuous moderate training (CMT) group (N=10)
Main outcome variables
In general, the purpose of this exercise is to reduce inflammatory factors in type 2 diabetic patients and to slow down the progression of the disease and the complications of the disease.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181129041797N1
Registration date: 2018-12-25, 1397/10/04
Registration timing: registered_while_recruiting

Last update: 2018-12-25, 1397/10/04
Update count: 0
Registration date
2018-12-25, 1397/10/04
Registrant information
Name
Zahra Ghaemmaghami
Name of organization / entity
Shahid Rajaie Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2197
Email address
z.ghaemmaghami@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisons effect of eight weeks high intensity interval training (HIIT) and continuous moderate training (CMT) on plasma levels of Calprotectin and IL-6 in type 2 diabetic persons
Public title
The effect of two types of aerobic exercise on inflammatory factors in type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes Body mass is between 25 and 35 kg / m 2 Age range 35 to 60 years
Exclusion criteria:
People with cardiovascular disease People who have kidney and liver problems People with pulmonary disease People who have gout or orthopedic restrictions smokers Alcoholics
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool: such as random numbered table, Sealed envelope, statistical software
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is done triple blind and the only researcher knows how to assign individuals to different groups.In general, all participants in this project are unaware of what kind of sports group they are said to be, and the researcher will individually give the exercises to individuals and will not be explained to people about the type and name of the exercise. Only the type of exercises that are aerobic on a treadmill will be provided to individuals. In fact, the data analyst, clinical caregiver, outcome assessor, as well as the safety committee and data monitoring will not know how to assign exercises.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Shahid Rajaee Cardiology Research Center
Street address
Shahid Rajaee Cardiology Research Center, Intersection of Niayesh, Valiasr street
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.RHC.REC.1397.049

Health conditions studied

1

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

Primary outcomes

1

Description
Plasma levels of Calprotectin
Timepoint
Before starting the training protocols and 8 weeks later (after completing the practice protocols)
Method of measurement
blood sampling

2

Description
plasma levels of IL-6
Timepoint
Before starting the training protocols and 8 weeks later (after completing the practice protocols)
Method of measurement
blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1:High intensity interval training that performs interval aerobic training for 8 weeks and 3 sessions per week.
Category
Diagnosis

2

Description
Intervention group 2: Continuous moderate training that will performs continuous aerobic exercise for 8 weeks and 3 sessions a week
Category
Diagnosis

3

Description
Control group: The control group is not given any training
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان شهید رجایی
Full name of responsible person
Zahra ghaemmaghami
Street address
Shaheed Rajaee Cardiology Research, Intersection of niayesh, Valiasr st
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 1021
Fax
+98 21 2204 2026
Email
Z.ghaemmaghami@rhc.ac.ir

2

Recruitment center
Name of recruitment center
Diabetes Research Center, Endocrinology and Metabolism Research Institute University of Tehran
Full name of responsible person
camelia Rambod
Street address
Shariati ST, Kargar shomali ST
City
Tehran
Province
Tehran
Postal code
1411715851
Phone
+98 21 8833 4192
Email
rambod.camelia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Rajaee Cardiovascular Research and Treatment Center
Full name of responsible person
Zahara Ghaemmaghami
Street address
Shahid Rajaee Cardiovascular Research and Treatment Center, Valiasr ST, Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
Z.ghaemmaghami@rhc.ac.ir
Grant name
Corresponding author, Dr. Mohsen Avandi, will be from Semnan University and some of the funding for this project will be from their Grant.
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan university
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
Persons

2

Sponsor
Name of organization / entity
Shahid Rajaee Cardiovascular Research and Treatment Center
Full name of responsible person
Dr.Majid Maleki
Street address
Shahid Rajaee Cardiovascular Research and Treatment Center, Valiasr ST, Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
Sr.alizadeh9191@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaee Cardiovascular Research and Treatment Center
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 Rajaee Cardiovascular Research and Treatment Center
Full name of responsible person
Zahra ghaemmaghami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist
Street address
Shahid Rajaee Cardiovascular Research and Treatment Center,Intersection of Niayesh, Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2197
Fax
+98 21 2204 2026
Email
Z.ghaemmaghami@rhc.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Mohsen Avandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Central Organization of Semnan University,in front of the Sokan Park, Semnan
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3365 4100
Fax
+98 23 3332 1005
Email
mohsenavandi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan university
Full name of responsible person
Mohsen Avandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Central Organization of Semnan University, in front of the Sokan Park, Semnan
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3365 4100
Email
mohsenavandi@gmail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, the personal information of the participants in the project, such as age range, height range, weight range, BMI range, will be published as a table. Also, upon completion of the protocol, the result of the effect of the protocol on the specified factors, Insulin resistance and HA1c will also be published.
When the data will become available and for how long
Access time since 1398
To whom data/document is available
All participants in this project can be informed on request if they so request. Also, all diabetics at the Shahid Rajaee Cardiology and Heart Disease Hospital, Tehran University of Medical Sciences and Semnan University can access the results of this project. Researchers at different universities.People who working in hospital rehab centers.It is important to point that people outside the project, at academic levels with the reason for the request, can get results if they are interested.
Under which criteria data/document could be used
Participants in the study and diabetics at Shahid Rajaee Hospital and Tehran University of Medical Sciences Diabetes Clinic To know how the protocols affect the conditions of their disease, they can inform the results and documentation so that they can be used if the protocols are useful. Researchers also access documents in order to use results in similar research. People working in rehab groups can also use documentation and protocols to perform protocols for diabetics.
From where data/document is obtainable
People can submit their requests to the following email addresses: mohsenavandi@gmail.com Z.ghaemmaghami@rhc.ac.ir rambod.camelia@gmail.com s.alizadeh@semnan.ac.ir
What processes are involved for a request to access data/document
Applicants send an email with the subject of the request to the addresses provided. Upon receipt of the email, a form will be sent to them, specifying the individuals and the reason for their request will be recorded in this form after completing the form and re-submitting the form to The email documentation will be available as pdf files.
Comments
Loading...