The effect of aerobic exercise on cardiac inflammatory markers in women with type 2 diabetes
Design
In this study, 36 participants will be randomly divided into 3 groups: high intensity intermittent training, moderate intensity continuous training and control group.Clinical trial work with parallel groups
Settings and conduct
The subjects of this study will be selected from the patients of Tehran Diabetes Clinic and the training program will be performed in the rehabilitation center of this center. Blood sampling will also be performed in the laboratory of this center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with type 2 diabetes, according to the diagnosis of a doctor who has been diagnosed with the disease for at least 3 years, had no change in the use ofantihypertensive drugs, blood lipids and blood pressure in the last two months and blood pressure should not exceed 160.95 mm Hg.
Intervention groups
1-high intense intermittent training group (12 people). 2- Medium intensity continuous training group (12 people). 3- Control group (12 people without training)
The effect of aerobic exercise type on cardiac inflammatory markers in women with type 2 diabetes
Public title
The effect of aerobic exercise on cardiac inflammatory factors in diabetic women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the age range of 35 to 50 years
They develop type 2 diabetes by measuring their fasting glucose twice (mean above 125 mg / dL) and having it approved by a doctor.
Body mass index higher than 25 and less than 30 kg / m2
Lack of cardiovascular disease
Lack of regular physical exercise in the last year
No restrictions or physical problems to participate in the training program
Exclusion criteria:
Failure to sign informed written consent
Smoking and alcohol at least once a week
Pregnancy and lactation
Menopause
Hyper tention
Liver and kidney failure
Age
From 35 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty-six diabetic patients are randomly divided into three groups of 12 through a random number table. The first and second groups are selected as the intervention group and the third group is selected as the control group.
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 Islamic Azad University, Research Sciences Branch
Street address
Shohada Hesarak Boulevard, University Square, Ehe end of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2020-06-24, 1399/04/04
Ethics committee reference number
IR.IAU.SRB.REC.1399.011
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
Pentraxine 3
Timepoint
Before training protocols and 12 weeks later (after training protocols are completed)
Method of measurement
Using the ELISA laboratory kit
2
Description
Cardiotrophin 1
Timepoint
Before training protocols and 12 weeks later (after training protocols are completed
Method of measurement
Using the ELISA laboratory kit
3
Description
Galactin 3
Timepoint
Before training protocols and 12 weeks later (after training protocols are completed
Method of measurement
Using the ELISA laboratory kit
4
Description
Interleukin 6
Timepoint
Before training protocols and 12 weeks later (after training protocols are complet
Method of measurement
Using the ELISA laboratory kit
Secondary outcomes
1
Description
Glucose
Timepoint
Before training protocols and 12 weeks later (after training protocols are completed)
Method of measurement
Pars Azmoun Company Kit
2
Description
Insulin
Timepoint
Before training protocols and 12 weeks later (after training protocols are completed)
Method of measurement
Insulin ELISA Kit
3
Description
Insulin resistance
Timepoint
Before training protocols and 12 weeks later (after training protocols are completed)
Method of measurement
Evaluation of homeostasis model (HOMA-IR)
Intervention groups
1
Description
The first intervention group (high-intensity interval training): consists of 10 minutes of warm-up with an intensity of 50-60% of the maximum heart rate, followed by four intense four-minute intervals with an intensity of 90% of the maximum heart rate, and after At each intense alternation, subjects take three minutes of active rest at 50-60% of their maximum heart rat.This training program is performed for 12 weeks and three sessions per week.
Category
Prevention
2
Description
The second intervention group ( moderate intensity continuous training): consists of 10 minutes of warm-up with an intensity of 50-60% of the maximum heart rate. Subsequently, continuous training is performed for 47 minutes and with an intensity of 70-60% of the maximum heart rate. This training program is performed for 12 weeks and three sessions per week.
Category
Prevention
3
Description
Control group: The subjects in the control group continue their usual daily program and do not participate in any regular physical training program until the end of the research.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Diabetes Clinic
Full name of responsible person
Maryam Pourabbas
Street address
Tehran Diabetes Clinic, Hayat Crossroads, Shahrivar West Ave., North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8833 4190
Email
shilamontazer@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sina Forouzeh
Street address
University of scientific research, Shohada Hesarak Boulevard, University Square , The end of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 9827
Email
Basic-fa@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant, Islamic Azad University - Research Sciences Branch
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data after unidentifiable individuals
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Participants in the study can learn about the results and documents in detail to find out how the protocols affect their disease conditions so that they can use the protocols if they are useful. Researchers can also use the results in similar studies access documents. People working in rehabilitation departments to perform registered protocols for diabetics can also from use documentation and protocol.
From where data/document is obtainable
Send your request to the following email address .
Masoumeh.gholaman@gmail .com
What processes are involved for a request to access data/document
People requesting an email with the subject of the request to the address .They will send a form for them as soon as they receive it.Will post the profile of the people and the reason for their request in this the form will be registered after completing the form and resending the form to the item email comments on the documents will be provided as a pdf file.