Protocol summary

Summary
Objective: Adipolin is a novel anti-inflammatory adipokine with insulin-sensitizing effects that ameliorates glucose intolerance and insulin resistance. . This study investigated effect of intensity of aerobic training on adipolin and furin levels and insulin resistance index in sedentary overweight men. Design: 36 sedentary؛ overweight men (BMI>25 Kg/m2)؛ obesity and overweight not related to hypothyroidism؛ healthy men؛ without kidney disease diabetes؛ no physical problems &injury؛ no physical activity during three years ago ؛ assigned randomly. in three training groups of low and high intensity and control groups. People who had not above conditions exclusion from study. Low intensity training group run at intensity of 50-70 % of maximal heart rate .high intensity training group run at 70-90% of maximal heart rate at 30-45 minutes per session and three sessions per week for 10 weeks and Control group were without intervention. Levels of adipolin, furin, insulin and fasting glucose and anthropometric indices measured before and 72 hours after last training session. Adipolin and furin were primary outcome measure and insulin resistance index was secondary outcome measure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010310709N3
Registration date: 2016-01-16, 1394/10/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Najmeh Rezaeian
Name of organization / entity
Islamic Azad University, Bojnourd branch
Country
Iran (Islamic Republic of)
Phone
+98 58 3292 2853
Email address
n.rezaeian@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-07-06, 1393/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the impact of training intensity in the plasma levels of adipolin and furin in obese middle age men
Public title
Effect of aerobic training on adipolin & furin
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:Middle age men؛ sedentary ؛ overweight( (BMI>25 Kg/m2)؛ obesity and overweight not related to hypothyroidism؛ healthy men؛ without kidney disease diabetes؛ no physical problems &injury؛ no physical activity during three years ago ؛ assigned randomly. Exclusion criteria: People who had not above conditions.
Age
From 35 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
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 of Zahedan Medical Science University
Street address
Zahedan Medical Science University، Daneshghah street
City
Zahedan
Postal code
Approval date
2016-01-10, 1394/10/20
Ethics committee reference number
01/06/3901/1/21529 - د

Health conditions studied

1

Description of health condition studied
Insulin Resistance
ICD-10 code
E10 ، E11،
ICD-10 code description
Insulin-dependent diabetes mellitus،Non-insulin-dependent diabetes mellitus، Malnutrition-related diabetes mellitus،Other specified diabetes mellitus،Unspecified diabetes mellitus

Primary outcomes

1

Description
Adipolin
Timepoint
Before of first training &72 hours after last session
Method of measurement
Elisa

2

Description
Furin
Timepoint
Before of first training &72 hours after last session
Method of measurement
Elisa

Secondary outcomes

1

Description
Insulin Resistance Index
Timepoint
Before of first training &72 hours after last session
Method of measurement
HOMA-IR=(fasting glucose x fasting insulin)/22.5

Intervention groups

1

Description
Control group:Without intervention
Category
Lifestyle

2

Description
12Subjects in high intensity group run at 70-90 % of maximal heart rate 30-45 minutes per session.
Category
Lifestyle

3

Description
12Subjects in low intensity group weeks of aerobic run at 50-70 % of maximal heart rate 30-45 minutes per session.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mostafazadeh(Takhti) Sports Complex
Full name of responsible person
Zohreh Barahouei Jamar
Street address
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Karaj Payame Noor University
Full name of responsible person
Dr Dehghandar
Street address
University of Payame Noor، Karaj
City
Karaj
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 Karaj Payame Noor University
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
Karaj University of Payame Noor
Full name of responsible person
Zohreh Barahouei Jamar
Position
MSc student
Other areas of specialty/work
Street address
Sadra7، Left side sixth house، Zibashahr
City
Zahedan
Postal code
9817915157
Phone
+98 54 3328 6488
Fax
Email
Z.barahouei@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj Payame Noor University
Full name of responsible person
Zohreh Barahouei Jamar
Position
MSc student
Other areas of specialty/work
Street address
Sadra7، Left side sixth house، Zibashahr
City
Zahedan
Postal code
9817915157
Phone
+98 54 3328 6488
Fax
Email
Z.barahouei@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Karaj Payame Noor University
Full name of responsible person
Zohreh Barahouei Jamar
Position
MSc student
Other areas of specialty/work
Street address
Sadra7، Left side sixth house، Zibashahr
City
Zahedan
Postal code
9817915157
Phone
+98 54 3328 6488
Fax
Email
Z.barahouei@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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