This study will be conducted as clinical randomized trial in Razi hospital Mazandaran Iran. The purpose of this study is determination the effect of aerobic exercise on insulin resistance in Type 2 Diabetes. The trial will be performed on 50 Patients. The participant are divided to two groups: case (25) and control (25) by random allocation.The including criteria are 30-65 years old diabetic type 2 patients,who are agree with participating and treated with oral drags. The excluding criteria were inflammatory disease, heart disease. pregnancy, muscluskeletal disorders,athletic and consumption of opium and alcohol. Individual patient data and blood parameters including FBS, Insulin are collected in cheek list. The training progrom is moderate to sever aerobic exercies 50 minutes daily 3 weeklt for 8 weeks. The insulin resistance is assessed by Homa- IR scale for every 4 weeks. All of measuring are performed in control group without any intervention. Descriptive statistic, Chi- square and t- test are used for data analysis.Insulinis compard between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201258822N1
Registration date:2012-03-03, 1390/12/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-03, 1390/12/13
Registrant information
Name
Narges Motahari
Name of organization / entity
Mazandaran University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7345
Email address
n.motahari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic exercise on insulin resistance in Type 2 Diabetes
Public title
The effect of aerobic exercise on insulin resistance in Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : The including criteria were patient with Type 2 Diabetes without assumption of insulin.
Exclusion criteria : The excluding criteria were inflammatory disease; heart disease; pregnancy ; consumption of opium and alcohol.
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mazandaran University of Medical Sciences
Street address
Building No. 2 Mazandaran University of Medical Sciences ,Moallem Square
City
Sari
Postal code
Approval date
2011-12-21, 1390/09/30
Ethics committee reference number
14-90-H
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Insulin resistance
Timepoint
In First of Study and every 4 weeks for two months
Method of measurement
Measurement of Blood parameters
Secondary outcomes
1
Description
decrease BMI
Timepoint
In First of Study and every 4 weeks for two months
Method of measurement
measuring the weight and centimeters
Intervention groups
1
Description
The training program is moderate to sever aerobic exercise 50 minutes daily 3/weekly for 8 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital diabetes clinic and Vali-Asr
Full name of responsible person
narges motahari
Street address
Razi hospital diabetes clinic and Vali-Asr ,sari sreet
City
ghaemshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Building No. 2 Mazandaran University of Medical Sciences ,Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Motahari
Position
Master of Sports Physiology
Other areas of specialty/work
Street address
School of Nursing and Midwifery Nasibeh,Vesal Street,Amirmazndrani Street
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
n.motahari@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Motahari
Position
Master of Sports Physiology
Other areas of specialty/work
Street address
School of Nursing and Midwifery Nasibeh,Vesal Street,Amirmazndrani Street
City
Sari
Postal code
4816715793
Phone
+98 15 1226 7342
Fax
Email
n.motahari@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Motahari
Position
Master of Sports Physiology
Other areas of specialty/work
Street address
School of Nursing and Midwifery Nasibeh,Vesal Street,Amirmazndrani Street
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
n.motahari@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)