Clinical trial of effect of selective aerobic training on insulin resistance, blood glucose level and serum leptin in male patients with diabetes type 2
Objectives: Survey of effecting of selective aerobic training on insulin resistance, blood glucose level and serum Leptin in male patients with diabetes type 2 , Design: Not blinded randomized clinical trial Setting and conduct: 60 diabetic patients will be divided to the intervention group that will be done aerobic exercise, and the control group that will not be done aerobic exercise Major Inclusion and Exclusion criteria: Inclusion criteria: type II diabetic patients; men; age between 30 to 50 years
Exclusion criteria: women; persons under 30 and over 50 years Intervention: in the intervention group exercise will be done with intensity equivalent heart rate 70-60%, on the ergometer bicycle and treadmill for 12 weeks, 3 sessions per week , 60 minutes per session and in the control group will not exercise program
Main outcome measures (variablesof): insulin, glucose and leptin level of blood
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016011822583N4
Registration date:2016-02-23, 1394/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-23, 1394/12/04
Registrant information
Name
Mohsen Shoja
Name of organization / entity
Esfarayen Faculty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 85 3722 2469
Email address
mohsenshoja61@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Esfarayen Faculty of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effect of selective aerobic training on insulin resistance, blood glucose level and serum leptin in male patients with diabetes type 2
Public title
Effect of selective aerobic training on insulin resistance and serum leptin in patients given to diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: type II diabetic patients; men; age between 30 to 50 years
Exclusion criteria: women; persons under 30 and over 50 years
Age
From 30 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Sabzevar University of Medical Sciences
Street address
Razavi Khorasan, Sabzevar, Road of Shahrood, Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
1394.89.IR.MEDSAB.REC
Health conditions studied
1
Description of health condition studied
Diabetes Type II
ICD-10 code
(E11)
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Leptin of serum
Timepoint
3 months after intervention
Method of measurement
Evaluation of blood serum
2
Description
Blood glucose
Timepoint
3 months after intervention
Method of measurement
Evaluation of blood serum
3
Description
Insulin level
Timepoint
3 months after intervention
Method of measurement
Evaluation of blood
Secondary outcomes
1
Description
Triglycerides
Timepoint
3 months after intervention
Method of measurement
Evaluation of blood serum
2
Description
Blood pressure
Timepoint
3 months after intervention
Method of measurement
Clinical observation
Intervention groups
1
Description
In the intervention group exercise will be done with intensity equivalent heart rate 70-60%, on the ergometer bicycle and treadmill for 12 weeks, 3 sessions per week , 60 minutes per session.
Category
Lifestyle
2
Description
The control group will not exercise program.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian Diabetes Center
Full name of responsible person
Mahdi Esmaeilizadeh
Street address
Parsian Diabetes Center, Vakilabad Boulevard, Mashhad, Razavi Khorasan
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Esfarayen Faculty of Medical Sciences
Full name of responsible person
Es-hagh Ildarabadi
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North Khorasan
City
Esfarayen
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Esfarayen Faculty 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
Esfarayen faculty of Medical Sciences
Full name of responsible person
Mohsen Shoja
Position
MSc of Epidemiology
Other areas of specialty/work
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North Khorasan
City
Esfarayen
Postal code
9661856188
Phone
+98 58 3724 1601
Fax
+98 58 3723 8757
Email
mohsenshoja61@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarayen Faculty of Medical Sciences
Full name of responsible person
Mahdi Esmaeilizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North Khorasan
City
Esfarayen
Postal code
9661856188
Phone
+98 58 3724 1601
Fax
+98 58 3723 8757
Email
mahdiesmaeilizadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen Faculty of Medical Sciences
Full name of responsible person
Mohsen Shoja
Position
Msc of Epidemiology
Other areas of specialty/work
Street address
Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North khorasan
City
Esfarayen
Postal code
9661856188
Phone
+98 58 3724 1601
Fax
+98 58 3723 8757
Email
mohsenshoja61@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)