Protocol summary

Summary
This study aimed to investigate the effects of eight weeks of aerobic training on levels of high sensitivity-C reactive protein (HS-CRP), glycosylated hemoglobin, insulin, lipid parameters, and blood glucose level in women with type 2 diabetes. The population of this study was diabetic women who referred to Diabetes Center in Mashhad Shahid Ghodsi's Health Center. Twenty two volunteers were selected following primary screening by age and status of the medicine they were receiving and were randomly assigned into two experimental and control groups. All participants in the study were women with type 2 diabetes whose disease lasted at least for two years and none of them had chronic kidney disease, thyroid disorder, increased blood pressure and coronary artery diseases. The subjects in the experimental group received eight weeks (three sessions per week) of aerobic exercise training with intensity of 60 percent of maximum heart rate. Subjects in the control group did not receive the intervention. Forty eight hours before the start of the study and also after the last training session, after 12 hours of fasting, 10 cc blood was collected from the patients' brachial vein in a resting position to measure biochemical parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110611387N1
Registration date: 2013-03-11, 1391/12/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-11, 1391/12/21
Registrant information
Name
Akram Alizadeh
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1878 9008
Email address
ak_al209@stu.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Physical Education Ferdowsi University of Mashhad
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2012-07-02, 1391/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of long-term aerobic training on levels of high sensitivity-C reactive protein, glycosylated hemoglobin, Insulin, lipid parameters and glucose blood level in women with type 2 diabetes
Public title
The effect of Aerobic Training on laboratory parameters in patients with type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: diabetes, according to physician, willingness to participate in the study Exclusion criteria: patients with kidney, liver and respiratory therapy, patients treated with insulin, smoking, becoming exposed to severe stress (infections, diabetic foot surgery, severe emotional stress), depression and recreational drug use, risk of kidney stones having chronic kidney disease
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Vice Chancellor For Research, Ferdowsi University
Street address
Mashhad Ferdowsi University, Faculty of Physical Education and Sports Science, Azadi Square
City
Mashhad
Postal code
Approval date
2011-04-19, 1390/01/30
Ethics committee reference number
20661

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Hs-CRP
Timepoint
Before and after the intervention
Method of measurement
Strengthened immune-turbidimetric for measuring two points with a photometer

2

Description
glycosylated hemoglobin
Timepoint
Before and after the intervention
Method of measurement
Colorimetry

Secondary outcomes

1

Description
Insulin
Timepoint
Before and after the intervention
Method of measurement
Radio Immune Assay

2

Description
Triglyceride
Timepoint
Before and after the intervention
Method of measurement
blood test (mg per deciliter)

3

Description
High-density lipoprotein (HDL)
Timepoint
Before and after the intervention
Method of measurement
blood test (mg per deciliter)

4

Description
Low-density lipoprotein (LDL)
Timepoint
Before and after the intervention
Method of measurement
blood test (mg per deciliter)

5

Description
Total cholesterol
Timepoint
Before and after the intervention
Method of measurement
blood test (mg per deciliter)

6

Description
Fasting Blood Sugar
Timepoint
Before and after the intervention
Method of measurement
blood test (mg per deciliter)

Intervention groups

1

Description
In control group: subjects were without training during eight weeks
Category
N/A

2

Description
In experimental group: The exercise program consisted of eight weeks of aerobic training (3 sessions per week) with 60% maximum heart rate of the subjects
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Ghodsi Health Centers of Mashhad
Full name of responsible person
Nahid Bijeh
Street address
College of Ferdowsi University of Mashhad, Faculty of Physical Education and Sport Sciences, Azadi square
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research, Ferdowsi University
Full name of responsible person
Nahid Bijeh
Street address
College of Ferdowsi University of Mashhad, Faculty of Physical Education and Sport Sciences، Azadi square
City
Mashhad
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, Ferdowsi 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
Faculty of Physical Education and Sport Science, Ferdowsi University of Mashhad
Full name of responsible person
Akram Alizadeh
Position
Master student
Other areas of specialty/work
Street address
College of Ferdowsi University of Mashhad, Faculty of Physical Education and Sport Sciences, Azadi square
City
Mashhad
Postal code
Phone
+98 51 1878 9008
Fax
Email
akramalizadeh2011@gmail.com; ak_al209@stu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Physical Education and Sport Science, Ferdowsi university of Mashhad
Full name of responsible person
Akram Alizadeh
Position
Master student
Other areas of specialty/work
Street address
Mashhad Ferdowsi University, Faculty of Physical Education and Sport Sciences, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1878 9008
Fax
Email
akramalizadeh2011@gmail.com; ak_al209@stu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Physical Education and Sport Science, Ferdowsi University of Mashhad
Full name of responsible person
Akram Alizadeh
Position
Master student
Other areas of specialty/work
Street address
College of Ferdowsi University of Mashhad, Faculty of Physical Education and Sport Sciences, Azadi square
City
Mashhad
Postal code
Phone
+98 51 1878 9008
Fax
Email
akramalizadeh2011@gmail.com; ak_al209@stu.ac.ir
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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