The purpose of this study is to investigate and comparison the effects of 8 weeks aerobic training and combined training on levels of leptin and fasting blood glucose in men with type 2 diabetes. Twenty four men with type 2 diabetes who visit the diabetes center of Taleghani hospital in Kermanshah city, from June to August 2012, and be volunteer to participate in the study, will be subjects of this this clinical trial. Subjects should have a body mass index of more than 25, fasting blood glucose of lower than 300 milligram per deciliter, and ability to perform exercise training program. To perform the study procedure, subjects will randomly assign into 3 groups (n=8): aerobic training, combined training, and control group. Subjects in the training groups will perform exercise training for 8 weeks (3 sessions; each session for 1 hour) and subjects in the control group will not participate in any exercise program. Aerobic training will include running with 60 to 80 percent of maximal heart rate and combined training will include performing aerobic and resistance training in a session. Before and after the intervention period, levels of leptin hormone and fasting blood glucose will be measured to investigate the effects of exercise training interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406106611N2
Registration date:2014-06-30, 1393/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-30, 1393/04/09
Registrant information
Name
Zahra Bayat
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 83 3822 9422
Email address
zahra_bayat2008@yahoo.com
Recruitment status
Recruitment complete
Funding source
Razi University of Kermanshah, Kermanshah university of Medical Science
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of 8 Weeks Aerobic and Combined Training on levels of Leptin and Fasting Blood Glucose in People with Type 2 Diabetes
Public title
Comparison the Effect of 8 Weeks Aerobic and Combined Training on levels of Leptin and Fasting Blood Glucose in People with Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Suffering from type 2 diabetes; a body mass index of more than 25; ability to perform exercise training program; a fasting blood glucose level lower than 300 mg.dL-1
Exclusion criteria: not meeting the prescribed diet and drug regimen by diabetes center; any acute disease during the study period; Absence from a training protocol session
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blv-Kermanshah
City
Kermanshah
Postal code
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
9839
Health conditions studied
1
Description of health condition studied
Type 2 Diabete
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Level of Leptin Hormone
Timepoint
Two days before and after the intervention
Method of measurement
ng/ml- With Blood Test
2
Description
Fasting Blood Glucose
Timepoint
Two days before and after the intervention
Method of measurement
mg/dl-With Blood Test
Secondary outcomes
empty
Intervention groups
1
Description
Aerobic Training Group: 8 weeks of aerobic exercise, 3 times a week, 1 hour per session
Category
Other
2
Description
Combined training group: 8 weeks of combined exercise training, 3 sessions a week, 1 hour per session performing resistance and aerobic training
Category
Other
3
Description
Control group: not participate in any exercise program during the intervention period
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Diabete
Full name of responsible person
Dr Mehr Ali Rahimi
Street address
Center of Diabete-Shahid Beheshti Blv-Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Dr Vahid Tadibi
Street address
Bagh Abrisham-Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University of Kermanshah
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Kermanshah university of Medical Science
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti Blv, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah university of Medical Science
Proportion provided by this source
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
Razi University
Full name of responsible person
Dr Vahid Tadibi
Position
Assosiate Professor in Exercise Physiology/Faculity member
Other areas of specialty/work
Street address
Bagh Abrisham-Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 7609
Fax
+98 83 1427 4585
Email
vtadibi@yahoo.com vahidtadibi@razi.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Dr Vahid Tadibi
Position
Associate Perofessor in Exercise Physiology
Other areas of specialty/work
Street address
Bagh Abrisham-Kermanshah
City
Kermanshah
Postal code
Phone
+98 84277609
Fax
+98 83 1427 4585
Email
vtadibi@yahoo.com vahidtadibi@razi.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Zahra Bayat
Position
MA in Exercise Physiology
Other areas of specialty/work
Street address
Bagh Abrisham-Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1822 0512
Fax
Email
zahra_bayat2008@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)