Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
Physical Activity and diabetes
IRCT registration information
IRCT registration number: IRCT20171104037225N1
Registration date: 2017-11-28, 1396/09/07
Registration timing: retrospective

Last update: 2017-11-28, 1396/09/07
Update count: 0
Registration date
2017-11-28, 1396/09/07
Registrant information
Name
Exir Vizvari
Name of organization / entity
Department of Physical education of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 3255
Email address
vizvariexir@yahoo.com
Recruitment status
Recruitment complete
Funding source
with Exir vizvari
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-09-01, 1396/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two types of aerobic exercises with different severity on serum SIRT1, some hepatocytes and angiogenic indices in women with type 2 diabetes
Public title
The effect of two types of aerobic exercises with different severity on serum SIRT1, some hepatocytes and angiogenic indices in women with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Iran
Street address
Pepartment of Madical Science,Azad University,sari
City
Sari
Postal code
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
IR.IAU.SARI.REC.1396.55

Health conditions studied

1

Description of health condition studied
type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Non insulin dependent diabete mellitus

Primary outcomes

1

Description
SIRT1
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
ELISA kit(Bio Vision)- ng/ml

2

Description
Fibroblast Growth Factor21
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
By ELISA- pg/ml

3

Description
Fetuin A
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
ELISA- ng/ml

4

Description
Nitric Oxide
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
ELISA- μmol/l

5

Description
Vascular Endothelial Growth Factor
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
ELISA- ng/ml

6

Description
Endostatin
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
ELISA- ng/ml

Secondary outcomes

1

Description
FBS
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
Autoanalyzer- mg/dl

2

Description
Glc 2HR
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
mg/dl

3

Description
A1c
Timepoint
Before the intervention and after 8 weeks intervention
Method of measurement
%

4

Description
TG
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
mg/dl

5

Description
Chol
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
mg/dl

6

Description
HDL
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
mg/dl

7

Description
LDL
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
mg/dl

8

Description
weight
Timepoint
Before the intervention (exercise) and after 8 weeks intervention
Method of measurement
Kg

Intervention groups

1

Description
Control group: with no exercise Exercise groups: first group:5 sessions per week with moderate intensity for 8 weeks second group:3sessions per week with vigorous intensity for 8 weeks
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Center
Full name of responsible person
Dr Maryam Zahedi (internest)_ Mrs Atena Shams
Street address
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
personality
Full name of responsible person
Exir Vizvari
Street address
number4- 9th alley- Sayad shirazi
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
personality
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
Department of Physical education and sport science
Full name of responsible person
Exir Vizvari
Position
Post gratuated student
Other areas of specialty/work
Street address
Sari- Ialamic Azad University
City
Sari
Postal code
Phone
+98 17 3254 3255
Fax
Email
vizvariexir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ialamic azad University of Iran
Full name of responsible person
Exir Vizvari
Position
Post gratuate student
Other areas of specialty/work
Street address
number4- 9th alley- sayad shirazi street
City
Gorgan
Postal code
4917977354
Phone
+98 981732543255
Fax
Email
vizvariexir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Univetsity of Sari
Full name of responsible person
Exir vizvari
Position
Post gratuate student
Other areas of specialty/work
Street address
Number4- 9th alley - Sayad Shirazi street
City
Gorgan
Postal code
4917977354
Phone
+98 981732543255
Fax
Email
vizvariexir@yahoo.comvizvariexir@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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