The purpose of this study will be investigation of weight bearing interval training and non-weight bearing interval training on endothelial function of type 2 diabetes and relation with effective mechanisms in improvement endothelial function. The study design will be base on double blind. seventy patient will be equally divided and randomized into four groups including high intensity interval training on treadmill, high intensity interval training on ergometer, high intensity interval training combination of treadmill and ergometer.Including criteria: included having a history of type 2 diabetes more than two years, glycosylated hemoglobin <6% (HbA1C <6%), body mass index over 25, hypertension uncontrolled pre or I stage, no history of 6 months of regular exercise (more than one day a week) to do the study. Exclusion criteria included fasting blood glucose over 400 mg / dl, functional limitations (such as osteoarthritis), liver or kidney failure, history of myocardial infarction or coronary artery bypass surgery or angioplasty, chronic heart failure, arrhythmias, HbA1C > 10%. Protocol of treadmill 6*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax), ergometer 6*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax) and combination protocol 3*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax) on treadmill and 3*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax) on ergometer will be undertaken for 12weeks. Indicators of FMD, NOx, ET-1, apelin, arterial stiffness and inflamatory cytokines will be measured before and after the 12 week training program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100423002N2
Registration date:2016-03-04, 1394/12/14
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Alireza Ghardashi Afousi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8201 5031
Email address
ghardashi.a@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of differential exercise training on endothelial function of type 2 diabetes and relation with inflammatory cytokines
Public title
Effect of exercise training on endothelial function of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: having a history of type 2 diabetes more than two years; glycosylated hemoglobin <6% (HbA1C <6%); body mass index over 25; hypertension uncontrolled pre or I stage; no history of 6 months of regular exercise (more than one day a week) to do the study. Exclusion criteria: fasting blood glucose over 400 mg / dl; functional limitations (such as osteoarthritis); liver or kidney failure; history of myocardial infarction or coronary artery bypass surgery or angioplasty; chronic heart failure; arrhythmias;, HbA1C > 10%.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Tehran
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
57
Health conditions studied
1
Description of health condition studied
type 2diabetes
ICD-10 code
E 11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Nitrite/Nitrate plasma
Timepoint
before and after 12 week intervention
Method of measurement
ELISA kit
2
Description
Endothelin-1
Timepoint
before and after 12 week intervention
Method of measurement
ELISA kit
3
Description
Flow mediated dilation
Timepoint
before and after 12 week intervention
Method of measurement
Ultrasound doppler
4
Description
Carotid intima-media thickness
Timepoint
before and after 12 week intervention
Method of measurement
Ultrasound doppler
5
Description
Insulin resistance
Timepoint
before and after 12 week intervention
Method of measurement
HOMA-IR
6
Description
Glucose
Timepoint
before and after 12 week intervention
Method of measurement
Enzymatic
7
Description
Applin
Timepoint
before and after 12 week intervention
Method of measurement
ELISA kit
8
Description
peak consumption oxygen
Timepoint
before and after 12 week intervention
Method of measurement
Gas analyser system
9
Description
Diastolic and systolic blood pressure
Timepoint
before and after 12 week intervention
Method of measurement
oscillometric device
10
Description
Heart rate rest
Timepoint
before and after 12 week intervention
Method of measurement
Cornometer/ numbere
11
Description
Lipid profile
Timepoint
before and after 12 week intervention
Method of measurement
Enzymatic
12
Description
Malondealdehid
Timepoint
before and after 12 week intervention
Method of measurement
ELISA kit
13
Description
Glutathion proxidase
Timepoint
before and after 12 week intervention
Method of measurement
ELISA kit
14
Description
Von willbrand factor
Timepoint
before and after 12 week intervention
Method of measurement
ELISA kit
15
Description
Insulin
Timepoint
before and after 12 week intervention
Method of measurement
ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: ergometer 6* (4 minutes at 85-90% HRmax and 3 minutes active interval at 55-60% HRmax)
Category
Rehabilitation
2
Description
Intervention group 2: treadmill 6* (4 minutes at 85-90% HRmax and 3 minutes active interval at 55-60% HRmax)
Category
Rehabilitation
3
Description
Intervention group3: combination group including 3* (4 minutes at 85-90% HRmax and 3minute active interval at 55-60% HRmax) on treadmill and 3* (4 minutes at 85-90% HRmax and 3minute active interval at 55-60% HRmax) on ergometer.
Category
Rehabilitation
4
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
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Alireza Ghardashi Afousi
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Postal code
Phone
+98 21 8201 5031
Fax
Email
Ghardashi.a@ut.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Postal code
Phone
+98 21 8201 5031
Fax
Email
Ghardashi.a@ut.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Postal code
Phone
+98 21 8201 5031
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)