Protocol summary

Summary
The aim of this study is to determine the changes in vaspin, metabolic syndrome factors and physical fitness after 8 weeks of Resistance training in elderly men with type 2 diabetes. 18 patients with type II diabetes (40-60 years) referred to razi clinic in ghaemshahr voluntary participated in this study. Inclusion criteria were blood glucose in the range of 150 to 350 milligrams per deciliter and non insulin therapy. The participants were randomly divided into control (N=8) and experimental (N=10) groups based on blood glucose. The experimental group received Resistance training for 8 weeks, 3 sessions per week, 40 to 60 minutes each session and with an intensity of 40 to 80% of One-repetition maximum. The control group did not participate in any physical activity and continued their daily activities. Before and 48 hours after the last training session, the participants' blood samples were taken to determine fasting blood glucose, insulin, cholesterol, triglyceride, high-density lipoprotein (HDL), low density lipoprotein (LDL) and vaspin. Body weight, percent body fat and physical fitness of participants were also measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013060911772N1
Registration date: 2013-06-20, 1392/03/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-20, 1392/03/30
Registrant information
Name
Hassan Amouzad Mahdirejei
Name of organization / entity
Islamic Azad University-Sari branch
Country
Iran (Islamic Republic of)
Phone
+98 911 356 1385
Email address
hassanamouzad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University Sari Branch
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-05-31, 1392/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of 8 weeks resistance training on plasma vaspin, metabolic syndrome factors and physical fitness in elderly patients with type 2 diabetes
Public title
Effects of resistance training on elderly patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1- men with type 2 diabetes 2-Blood glucose in the range of 150 to 350 milligrams per deciliter 3-Not having Diabetes-related complications 4-The lack of insulin treatment Exclusion criteria: 1- Physician's disapproval of participating in exercises 2-Morbid obesity
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
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
Islamic Azad university Sari Branch
Street address
7 km sea Road Sari, Mazandaran Province
City
sari
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
11711

Health conditions studied

1

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

Primary outcomes

1

Description
Blood glucose
Timepoint
Before and 48 hr after intervention
Method of measurement
Enzymatic Method using Pars Azmoon kit

2

Description
Lipid profile including LDL, HDL, Cholesterol, Triglyceride
Timepoint
Before and 48 hr after intervention
Method of measurement
Enzymatic Colorimetric Method using Pars Azmoon kits

3

Description
vaspin
Timepoint
Before and 48 hr after intervention
Method of measurement
Enzymatic Method using Cusabio Biothech, China kit

Secondary outcomes

1

Description
Percent body fat
Timepoint
Before and 24 hr after intervention
Method of measurement
Before and 24 hr after intervention

2

Description
physical fitness
Timepoint
Before and 24 hr after intervention
Method of measurement
Before and 24 hr after intervention

Intervention groups

1

Description
Intervention1:Participating in 8 weeks resistance exercise training, 3 times a week, 40 to 60 minutes each session
Category
Treatment - Other

2

Description
Intervention2: Participating in daily activities
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi clinic in Ghaemshahr
Full name of responsible person
Hassan Amouzad Mahdirejei
Street address
City
Ghaemshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Islamic Azad Sari Branchi
Full name of responsible person
mohsen rabbani
Street address
7 km sea Road Sari, Mazandaran Province
City
Sari
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, University of Islamic Azad Sari Branchi
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
Islamic Azad University Sari Branch
Full name of responsible person
Hassan Amouzad Mahdirajei
Position
Master of Science in Exercise Physiology
Other areas of specialty/work
Street address
7 km sea Road Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 15 2663 3253
Fax
Email
hassanamouzad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Hassan Amouzad Mahdirajei
Position
Master of Science in Exercise Physiology
Other areas of specialty/work
Street address
7 km sea Road Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 15 2663 3253
Fax
Email
hassanamouzad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Hassan Amouzad Mahdirajei
Position
Master of Science in Exercise Physiology
Other areas of specialty/work
Street address
7 km sea Road Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 15 2663 3253
Fax
Email
hassanamouzad@yahoo.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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