The effect of concurrent training order on some mitochondrial, ribosome biogenesis regulatory myokines and insulin resistance in type 2 diabetes patient
Comparison the effect of concurrent training order on some mitochondrial, ribosome biogenesis regulatory myokines and insulin resistance in type 2 diabetes patient
Design
Randomized clinical trial, with control group and parallel exercises groups
Settings and conduct
The subjects will be trained in two training group for 12 weeks. The aerobic-resistance group will perform at first the aerobic protocol and then the resistance protocol. Resistance-aerobic exercise group will perform at first the resistance protocol and then the aerobic protocol. All steps will be measured at Ferdowsi University of Mashhad.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having type 2 Diabetes, Body mass index 28 to 35, Age 40 to 50 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
Experimental groups: The aerobic-resistance and resistance-aerobic training groups will practice for 12 weeks (three sessions per week). The training protocol is the same for the training groups, the only difference will be in the sequence of exercises. The control group will be community based and without exercise.
The effect of concurrent training order on some mitochondrial, ribosome biogenesis regulatory myokines and insulin resistance in type 2 diabetes patient
Public title
Effect of exercise on 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 28-35
Age between 40-50 years
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 40 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization (random allocation rule) with 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 Ferdowsi University of Mashhad
Street address
Ferdowsi University of Mashhad, Azadi square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
1397.016.IR.MUM.FUM.REC
2
Ethics committee
Name of ethics committee
Ethics committee Mahshad University of Medical Sciences
Street address
Mahshad University of Medical Sciences, Azadi square.
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.MUMS.REC.1397.202
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Myostatin (MSTN)
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
2
Description
Follistatin (FSTL)
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
3
Description
Fibroblast Growth Factor 21 (FGF21)
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
4
Description
Irisin
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
5
Description
Insulin resistance
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
HOMA-IR method
6
Description
HbA1C
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
Nyco Card device
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: The aerobic-resistance group will exercise for 12 weeks and three sessions a week. The aerobic-resistance group will perform the aerobic protocol and then the resistance protocol during a training session. The aerobic exercise protocol is 1×10 minutes exercise with one minute active rest between the sets (with using treadmill). Resistance exercises include movements such as leg press, bench press, seated leg extension, lat pull down, lying leg curl, seated shoulder press, which there are include the main muscles of the lower trunk and upper trunk and they will be done by the machine.
Category
Prevention
2
Description
The second intervention group: The resistance-aerobic group will exercise for 12 weeks and three sessions a week. The resistance-aerobic group will perform the resistance protocol and then the aerobic protocol during a training session. The aerobic exercise protocol is 1×10 minutes exercise with one minute active rest between the sets (with using treadmill). Resistance exercises include movements such as leg press, bench press, seated leg extension, lat pull down, lying leg curl, seated shoulder press, which there are include the main muscles of the lower trunk and upper trunk and they will be done by the machine.
Category
Prevention
3
Description
Control group: community-based and untrained.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian Diabetes Clinic
Full name of responsible person
Aliakbar Raouf Saeb
Street address
chamran 8, emam reza square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9144583392
Phone
+98 51 3223 6843
Email
dr.raoof@yahoo.com
Web page address
http://www.parsiandiabetes.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Nahid Bijeh
Street address
Ferdowsi University of Mashhad, Azadi square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5403
Email
bijeh@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
Nahid Bijeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Sport Sciences, Ferdowsi University of Mashhad, Azadi square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5403
Email
bijeh@um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Nahid Bijeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Sport Sciences, Ferdowsi University of Mashhad, Azadi square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5403
Email
bijeh@um.ac.ir
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.