Effect of 12 weeks of high-intensity interval training on flow-mediated dilation and circulating levels of adropin and nitrite / nitrate levels in women with type 2 diabetes
Design
Thirty women with type 2 diabetes are randomly divide into intervention and control groups, and randomization is performed by block randomization.
Settings and conduct
Thirty patients with type 2 diabetes are selected based on the criteria for entering the study from the Diabetes Clinic of Sanandaj (Iran). Flow mediated dilation, Serum adropin levels, Plasma nitrite/nitrate levels, lipid profile, glycosylated hemoglobin, plasma insulin levels, fasting blood glucose and anthropometric characteristics are measure before and after the 12 weeks intervention in both groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria including age range 20 to 44 years, more than 2 years history of type 2 diabetic, fasting blood glucose more than 125mg/dl and and no exercise training in the previous 6 months before the study: Criteria for not entering the study including glycosylated hemoglobin more than 10%, insulin therapy and having any chronic disease other than type 2 diabetic
Intervention groups
The intervention group performe high-intensity interval training for 12 weeks, three sessions per week and each session including four 4-min interval at 85-95% of HRmax and 3-min active recovery at 50-60% of HRmax. Control group maintain their daily activities and does not participate in any exercise-training program.
Effect of 12-week aerobic interval training on endothelial function and serum levels of Adropin in type 2 diabetic women
Public title
Effect of Interval Training on endothelial function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood glucose levels more than 125 mg/dL
Age range 20 to 44 years
More than 2 years history of type 2 diabetic
No exercise training in the previous 6 months before the study
Exclusion criteria:
HbA1c more than 10%
Insulin therapy
Having any chronic disease other than type 2 diabetic
Age
From 20 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants were randomly divided into two groups: high-intensity interval training and control. Randomization was performed by block randomization with a block size of two (Based on age and body mass index).
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 Kermanshah University of Medical Sciences
Street address
Central building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.KUMS.REC.1397.933
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Flow Mediated Dilation
Timepoint
Before and after 12 weeks exercise training
Method of measurement
Doppler ultrasound system
2
Description
Serum adropin levels
Timepoint
Before and after 12 weeks exercise training
Method of measurement
ELISA method
3
Description
Plasma nitrite/nitrate levels
Timepoint
Before and after 12 weeks exercise training
Method of measurement
Griess method
Secondary outcomes
1
Description
Lipid profile
Timepoint
Before and after the 12 weeks exercise training
Method of measurement
Enzymatic method
2
Description
Glycosylated hemoglobin
Timepoint
Before and after the 12 weeks exercise training
Method of measurement
Chromatography method
3
Description
Plasma insulin levels
Timepoint
Before and after the 12 weeks exercise training
Method of measurement
ELISA method
4
Description
Fasting blood glucose
Timepoint
Before and after the 12 weeks exercise training
Method of measurement
Enzymatic method
5
Description
Body Mass Index
Timepoint
Before and after the 12 weeks exercise training
Method of measurement
Weight in kilograms divided by height in meters squared
6
Description
Waist-Hip ratio
Timepoint
Before and after the 12 weeks exercise training
Method of measurement
Meter
7
Description
Body fat percentage
Timepoint
Before and after the 12 weeks exercise training
Method of measurement
Using Jackson-Pollock 3-spot formula by a Caliper
Intervention groups
1
Description
Intervention group: exercise training program performs three times a week for 12 weeks. Each exercise session consist of 10-min of warm up at 40% heart rate maximum(HRmax) and 25 minutes of running on treadmill, including four four-minute interval at 85-95% of HRmax and 3 minutes at 50-60% of HRmax and end with a 5 minutes cool down at 40% of HRmax.
Category
Rehabilitation
2
Description
Control group: No exercise intervention are performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Touhid Hospital Diabetes Clinic of Sanandaj
Full name of responsible person
.
Street address
Touhid Hospital, Basij Street
City
Sanandaj
Province
Kurdistan
Postal code
00000000000
Phone
+98 87 3328 6112
Email
shiva.abdi101@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Razi
Full name of responsible person
Vahid Tadibi
Street address
Razi University, Taq-e Bostan, Kermanshah
City
Kermanshai
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 3427 7605
Email
info@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Razi
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Shiva Abdi
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Directorate General of Kurdistan welfare, Shebli Blvd
City
Sanandaj
Province
Kurdistan
Postal code
1111111111
Phone
+98 87 3366 3612
Email
shiva.abdi101@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Shiva Abdi
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Directorate General of Kurdistan Welfare, Shebli Blvd
City
Sanandaj
Province
Kurdistan
Postal code
1111111111
Phone
+98 87 3366 3612
Fax
Email
shiva.abdi101@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Shiva Abdi
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Directorate General of Kurdistan Welfare, Shebli Blvd
City
Sanandaj
Province
Kurdistan
Postal code
1111111111
Phone
+98 87 3366 3612
Fax
Email
shiva.abdi101@yahoo.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
The data of the participating participants will be encrypted and will be published with the privacy of the patient and the confidentiality of the information.
When the data will become available and for how long
The date of access to the data is six months after the publication of the results.
To whom data/document is available
Only available to scholars working in academic and academic institutions
Under which criteria data/document could be used
The requirements for access to data include the sending of documents relating to the applicant's membership in academic and academic institutions, and the applicant is authorized to use this data in order to document for subsequent studies.
From where data/document is obtainable
You can use the email address to access the information: shiva.abdi101@yahoo.com
What processes are involved for a request to access data/document
The applicant will send the data to him at least one month later by sending valid credentials to members of the academic and research institutes at the email address of the author.