Comparison the effect of 12 weeks HIIT and MICT training on mitochondrial biogenesis regulatory myokines and glycemic index in type 2 diabetic men
Design
A randomized clinical trial, with a control group and parallel exercises groups
Settings and conduct
Experimental groups: The high-intensity interval training (HIIT) and medium-intensity continuous training (MICT) groups will practice for 12 weeks and three sessions per week.
The control group will be community-based and without exercise.
All steps will be measure at Aja University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having type 2 Diabetes, Body mass index 28 to 35, Age 45 to 55 years Exclusion criteria: Using insulin, having other metabolic disorders in addition to type 2 diabetes, having regular physical activity in the last six months
Intervention groups
High-intensity interval training (HIIT) group,
Medium-intensity continuous training (MICT) group ,
Control group
The effect of 12 weeks HIIT and MICT training on mitochondrial biogenesis regulatory myokines and glycemic index in type 2 diabetic men
Public title
Effect of aerobic exercise and type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Type 2 Diabetes (Fasting blood glucose greater than 126 mg/dL, Oral glucose tolerance test equal to or greater than 200 mg/dL, A1C level of 6.5 percent or higher)BMI 28-35Age between 45-55years
Exclusion criteria:
Use insulin
Having cardiovascular diseases, musculoskeletal disorders, liver disease, kidney disease, thyroid dysfunction
Having regular physical activity in at least the last six months
Age
From 45 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization (random allocation rule) by using the SAS software
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 Aja University of Medical Sciences
Street address
Aja University of Medical Sciences, fatemi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.AJAUMS.REC.1398.229
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
Diabetes m
ICD-10 code description
E08
Primary outcomes
1
Description
Fibroblast Growth Factor 21 (FGF21)
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
2
Description
Irisin
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
3
Description
Myostatin (MSTN)
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
4
Description
HbA1C
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
Nyco Card device
5
Description
Insulin resistance
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
HOMA-IR method
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: The high-intensity interval training protocol is 1×10 minutes exercise with one-minute active rest between the sets by using a treadmill.
Category
Prevention
2
Description
The second intervention group: The medium-intensity continuous training protocol is 35 minutes of exercise continuous by using a treadmill.
Category
Prevention
3
Description
Control group: community-based and untrained.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Aja University of Medical Sciences
Full name of responsible person
Dr Simin Riahy
Street address
Aja University of Medical Sciences, Fatemi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
riahy_simin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Simin Riahy
Street address
Aja University of Medical Science, Fatemi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
riahy_simin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
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
Artesh University of Medical Sciences
Full name of responsible person
Simin Riahy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Aja University of Medical Sciences, Fatemi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
riahy_simin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Simin Riahy
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Aja University of Medical Science, Fatimi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
riahy_simin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Morteza Motahari Rad
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Faculty of Sport Sciences, Ferdowsi University of Mashhad, Paradise Daneshgah, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948979
Phone
+98 51 3870 8915
Fax
Email
motahari.rad@mail.um.ac.ir
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
The whole data is potentially shared after unidentified individuals.
When the data will become available and for how long
The beginning of the data access period is 6 months after the publication of the articles.
To whom data/document is available
The data will be accessible only to researchers working in academic institutions.
Under which criteria data/document could be used
The data will be available as generally and non publication by the recipient.
From where data/document is obtainable
To receive research information, send an email to Reihane.nejati@gmail.com.
What processes are involved for a request to access data/document
Data will be sent after obtaining permission from the project manager.