Protocol summary

Study aim
Investigation of high- intensity interval training and continuous intensity moderate training on plasma levels of vaspin, asymmetric dimethyl-arginine, nitric oxide and relation with flow-mediated dilation in patient with type 2 diabetes.
Design
In this study, 75 participants divided into 3 groups high- intensity interval training, continuous intensity moderate training and control. Randomization was performed by block randomization with a block size of 4. Randomised clinical trial with single-blind and parallel groups.
Settings and conduct
This study was performed in University of Azad, research ad science brench and Metabolism and Diabetes Center of Shariati hospital.
Participants/Inclusion and exclusion criteria
Including criteria: included having a history of type 2 diabetes more than two years, glycosylated hemoglobin above 6% (HbA1C >6%), body mass index over 25, pre hypertension or I stage, no history of 6 months of regular exercise to do the study. Exclusion criteria included fasting blood glucose over 400 mg/dl, functional limitations (such as osteoarthritis), history of myocardial infarction or coronary artery bypass surgery or angioplasty, chronic heart failure, cardiac arrhythmias, smoking, insulin therapy and HbA1C > 10%.
Intervention groups
1. High- intensity interval training that program was including 12 intervals 1.5 minutes at 85-90% HR max that separated by 2 minutes active period at 55- 60% HR max. 2. Continues moderate intensity training consist of 42 minutes at 70% HR max. 3. Control group were encouraged to maintain their daily activities without exercise training.
Main outcome variables
Flow-mediated dilation, Nitrite/ Nitrate, Vaspin, Asymmetric dimethyl-arginine, Resistance insulin, Fasting glucose, VO2peak.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200810048351N1
Registration date: 2020-11-15, 1399/08/25
Registration timing: retrospective

Last update: 2020-11-15, 1399/08/25
Update count: 0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
mahnaz najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 2019
Email address
yazdan.setayesh98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-26, 1398/04/05
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
2019-07-01, 1398/04/10
Actual recruitment end date
2020-01-04, 1398/10/14
Trial completion date
2020-02-09, 1398/11/20
Scientific title
The effect of 12-weeks of interval and continuous training on vaspin, Asymmetric dimethyl-arginine and relationship with flow-mediated dilation in patients with type 2 diabetes
Public title
Effect of interval and continuous training on endothelial function in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of type 2 diabetes more than 2 years No history of 6 months of regular exercise Glycosylated hemoglobin above 6%(HbA1C >6%) Body mass index over 25 Pre hypertension or I stage
Exclusion criteria:
HbA1C over 10% Fasting blood glucose more than 400 mg/dl Functional limitations (such as osteoarthritis) Liver and kidney disease Myocardial infarction Coronary artery bypass surgery or angioplasty Chronic heart failure Cardiac arrhythmia's Smoking Uncontrolled BP (BP > 170/100 mmHg) Insulin therapy
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 75
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by blocking based on gender and age which performed by www.randomizatoin.com. The A code was used for women and B for men. The block size was 3. We used a code for a rage of 10 years. The 1 code included participants that ages was between 40-50 years, 2 code included participants that ages was between 50-60 years and 3 code included participants that ages was between 60-70 years. Therefore, if a person with a male gender and age range was 40 to 50 years, he would be assigned according to the system with A1 code, and if a person with a female gender and age range of 40 to 50 years, she would be assigned with B1 code. According to the 2 sexes of men and women and 3 age groups, combination of 6 types of codes including A1, A2, A3, B1, B2, B3 were placed in one block. In the data entry section, the number of subjects, codes and block size were entered. The output consisted of 12 blocks of 6 people and a block of 3 people, which was provided to us in the form of a table by the site itself. Therefore, each group consisted of 4 blocks and one code.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were aware of the study. They were assigned in groups based on randomization and the codes. The evaluators are specialists who were unaware of the grouping and the purpose of the study. Statistical analysis was performed by statisticians who were unaware of the study because the groups were sent to him based on coding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute of Iran
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-07-27, 1399/05/06
Ethics committee reference number
IR.SSRC.REC.1399.042

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
Vaspin
Timepoint
Before and after 12-weeks intervention
Method of measurement
ELISA kit

2

Description
Asymmetric dimethy-argenin
Timepoint
Before and after 12-weeks intervention
Method of measurement
ELISA kit

3

Description
Nitrite/nitrate
Timepoint
Before and after 12-weeks intervention
Method of measurement
ELISA kit

4

Description
Flow-mediated dilation
Timepoint
Before and after 12-weeks intervention
Method of measurement
Ultrasound doppler

5

Description
Insuline resistance
Timepoint
Before and after 12-weeks
Method of measurement
HOMA-IR

6

Description
Insulin
Timepoint
Before and after 12-weeks intervention
Method of measurement
ELISA kit

7

Description
Glucose
Timepoint
Before and after 12-weeks intervention
Method of measurement
ELISA kit

8

Description
Peak oxygen consumption
Timepoint
Before and after 12-week intervention
Method of measurement
Gas analyser system

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: High- volume high- intensity interval training that consists of 12 intervals 1.5 minutes at 85- 90% HRmax which separated by 2 minutes at 55-60% HRmax. Exercise training was performed 3 session per week for 12- weeks.
Category
Rehabilitation

2

Description
Intervention group 2: continuous moderate intensity training consists of 42 minutes at 70% HRmax. Exercise training was performed 3 session per week for 12- weeks.
Category
Rehabilitation

3

Description
Control group: normal condition without any exercise.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
diabetes and metabolic disease institute of Shariati haspital
Full name of responsible person
Ensieh Nasli Esfahani MD
Street address
Metabolism and Diabetes Center of Shariati hospital, North Kargar Street, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0218 4901
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Najafi
Street address
Faculty of Lecture, Human and Social Science, Islamic Azad University, Science and Research Branch, Daneshgah Blvd, Simon Bolivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
yazdan.setayesh98@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mahnaz Najafi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Lecture, Human and Social Science, Islamic Azad University, Science and Research Branch, Daneshgah Blvd, Simon Bolivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
yazda.setayesh98@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahaz Najafi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Lecture, Human and Social Science, Islamic Azad University, Science and Research Branch, Daneshgah Blvd, Simon Bolivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
yazdan.setayesh98@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Najafi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Lecture, Human and Social Science, Islamic Azad University, Science and Research Branch, Daneshgah Blvd, Simon Bolivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
yazdan.setayesh98@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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