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Effect of Eight Weeks Aerobic Training with Vitamin D Supplementation on AMPK, PGC-1a, PTP1B, and UCP-1 Gene Expression in The Visceral Adipose Tissue of Obese Rats with Type 2 Diabetes

Protocol summary

Study aim
The purpose of this study is to answer the question "Does eight weeks of aerobic exercise with vitamin D supplementation have any effect on expression of AMPK, PGC-1a, PTP1B and UCP-1 genes in visceral adipose tissue of obese rats with type 2 diabetes?".
Design
A randomized clinical trial with pre and post test design, along with six experimental, two control and a sham group on 90 type 2 diabetic rats. Lottery method was used for randomization.
Settings and conduct
This study with pre and post test design will be done, under supervision of physical education and basic sciences colleges, in order to determine the effect of aerobic training with vitamin D supplementation on AMPK, PGC-1a, PTP1B and UCP-1 gene expression in visceral adipose tissue of obese rats with type 2 diabetes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 2-3 months; having at least 300 gram weight; being type 2 diabetic patient; male gender. Exclusion criteria: movement disabilities.
Intervention groups
Control group (type 2 diabetes), training group (type 2 diabetes), vitamin D supplementation group (type 2 diabetes), training + vitamin D supplementation group (type 2 diabetes), Control group (obese without type 2 diabetes), training group (obese without type 2 diabetes), training + vitamin D supplementation group (obese without type 2 diabetes), vitamin D supplementation group (obese without type 2 diabetes), sham group.
Main outcome variables
AMPK gene expression; Expression of PGC-1a gene; Expression of PTP1B gene; UCP-1 gene expression; Irisin gene expression; Insulin resistance index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220510054809N1
Registration date: 2022-06-27, 1401/04/06
Registration timing: prospective

Last update: 2022-06-27, 1401/04/06
Update count: 0
Registration date
2022-06-27, 1401/04/06
Registrant information
Name
kimya khaledi
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3434 3515
Email address
kimyakhaledi19@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Eight Weeks Aerobic Training with Vitamin D Supplementation on AMPK, PGC-1a, PTP1B, and UCP-1 Gene Expression in The Visceral Adipose Tissue of Obese Rats with Type 2 Diabetes
Public title
Effect of Aerobic Training with Vitamin D Supplementation on Gene Expression of Visceral Adipose Tissue of Obese Rats with Type 2 Diabetes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age between8 to 9 months old Male sex To have type 2 diabetes in diabetic groups To have a minimum of 300 gram of weight No to have type 2 diabetes in non-diabetic obese groups
Exclusion criteria:
Movement disabilities
Age
From 8 months old to 9 months old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
At first, any qualified rat got a specific code. then, the codes was written on a similar piece of paper and placed in the first vase. Also, the name of groups was written on a similar piece of paper and placed in the second vase. In the following, after blending the papers in any vase, a code were drawn from first vase and assigned to the group that its name were drawn from the second vase, respectively. In case of completing the desired members of any group before ending the lottery, the name of that group was excluded from its vase.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, there are three training, supplementation, and training with supplementation groups in diabetic models; three training, supplementation, and training with supplementation groups in non-diabetic obese models; a diabetic group that receives a placebo; a non-diabetic obese group that receives a placebo; and a sham group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in research of Razi University of Kermanshah
Street address
No. 9, Razi University, Daneshgah Blvd, Taq-e Bostan Ave
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Approval date
2022-04-19, 1401/01/30
Ethics committee reference number
IR.RAZI.REC.1401.013

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes

Primary outcomes

1

Description
AMPK Gene Expression
Timepoint
Before intervention; after intervention.
Method of measurement
Western-Blot method using Kiagen Kit With 0/021 Pg/mL sensitivity.

2

Description
Expression Of PGC-1a Gene
Timepoint
Before intervention; after intervention.
Method of measurement
Real time-PCR Method using Mirnasy mini kit50 Kit With 0/06 ng/mL sensitivity.

3

Description
Expression Of PTP1B Gene
Timepoint
Before intervention; after intervention.
Method of measurement
Real time-PCR Method using RNeasy Commercial Kit With 0/06 ng/mL sensitivity.

4

Description
Expression Of UCP-1 Gene
Timepoint
Before intervention; after intervention.
Method of measurement
Eliza Double Sandwich Method using Cat no: ZB-11252-R9648 Kit With 0/06 ng/mL sensitivity.

5

Description
Insulin Resistance Index
Timepoint
Before intervention; after intervention.
Method of measurement
Serum Insulin by Elisa Method using Micro-calorie Metric Kit With 5/5 mg/dl Sensitivity. Insulin Resistance Index will be Determined Using Glucose And Insulin Concentrations And HOMA-IR formula.HOMA-IR= (Glucose Concentration × Insulin Concentration)÷22/5

Secondary outcomes

1

Description
Irisin Expression Gene
Timepoint
Before intervention; after intervention.
Method of measurement
Eliza Method using EASTBIOPHARM Kit With 0/023 mg/mL sensitivity.

Intervention groups

1

Description
Intervention group 1; Aerobic training (type 2 diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks
Category
Treatment - Other

2

Description
Intervention group 2; Aerobic training + Vitamin D supplementation (type 2 diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks; 5000 IU
Category
Treatment - Other

3

Description
Intervention group 3; Vitamin D supplementation (type 2 diabetes): 5000 IU vitamin D supplementation per week for 8 weeks.
Category
Treatment - Other

4

Description
Intervention group 4; Aerobic training (obese without diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks.
Category
Treatment - Other

5

Description
Intervention group 5; Aerobic training + Vitamin D supplementation (obese without diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks; 5000 IU
Category
Treatment - Other

6

Description
Intervention group 6; Vitamin D supplementation (obese without diabetes): 5000 IU vitamin D supplementation per week for 8 weeks
Category
Treatment - Other

7

Description
Control group 1; Control (type 2 diabetes): 8 weeks of receiving placebo, without aerobic exercise
Category
Placebo

8

Description
Control group 2; Control (obese without diabetes): 8 weeks of receiving placebo, without aerobic exercise
Category
Placebo

9

Description
Sham group: Being on treadmill without doing exercise.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Kimya Khaledi
Street address
No. 9, Physical Education and Sports Science College, Razi University, Razi Blvd, Taq-e Bostan Ave
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3427 7605
Fax
+98 83 3427 7605
Email
kimyakhaledi19@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Alireza Zebarjadi
Street address
No. 9, Razi University, Daneshgah Blvd, Taq-e Bostan Ave
City
kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3278
Fax
+98 83 3427 7605
Email
zebarjadiali20@yahoo.com
Web page address
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
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Rastegar Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
No. 9, Physical Education and Sports Science College, Razi University, Razi Blvd, Taq-e Bostan Ave
City
kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3427 7605
Fax
+98 83 3427 7605
Email
R.hoseini@razi.ac.ir
Web page address
https://phe.razi.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Rastegar Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
No. 9, Physical Education and Sports Science College, Razi University, Razi Blvd, Taq-e Bostan Ave
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
0098 34279265
Fax
+98 83 3427 7605
Email
R.hoseini@razi.ac.ir
Web page address
https://phe.razi.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
kimya khaledi
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Clinical exercise physiology
Street address
No. 9, Physical Education and Sports Science College, Razi University, Razi Blvd, Taq-e Bostan Ave
City
Kermanshah
Province
Kermanshah
Postal code
6793151498
Phone
+98 83 4618 4045
Fax
+98 83 4618 4045
Email
kimyakhaledi19@gmail.com
Web page address
https://phe.razi.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All the data are presentable.
When the data will become available and for how long
The data can be accessed 9 months after their publication.
To whom data/document is available
Only researchers of academic and scientific institutes can access the data.
Under which criteria data/document could be used
All the data are usable with consideration of the authors rights.
From where data/document is obtainable
1- Dr. Rastegar Hosseini (rastegar.hoseini@gmail.com). 2- kimya khaledi (kimyakhaledi19@gmail.com).
What processes are involved for a request to access data/document
For this purpose one can send their request via e-mail to the aforementioned persons; after reviewing the request, in case of discretion, the related data will be presented to them. This process can take long between 3 to 10 days.
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