The Effect of Eight Weeks Aerobic Training with Vitamin D Supplementation on Cardiac Biomarkers, VEGF-B Protein Levels, IGF-1 and Mir-1 Gene Expression in Cardiomyocytes of Type 2 Diabetic Rats.
This study aims to determine the effect of eight weeks of aerobic training with vitamin D supplementation on cardiac biomarkers, VEGF-B protein levels, and IGF-1 and Mir-1 gene expression in cardiomyocytes of type 2 diabetic rats.
Design
A randomized clinical trial with pre and post-test design, including six experimental, two control, and one sham group on 90 types 2 diabetic rats. The random number table method was used for randomization.
Settings and conduct
To determine the effect of eight weeks of aerobic training with vitamin D supplementation on cardiomyocytes of type 2 diabetic rats, this study will be done in the biology laboratory of Basic Sciences College of Razi University, under the supervision of Physical Education and Sports Science College of Razi University. In summary, after a one-week-familiarization, the main protocol (including vitamin D injection one time per week and aerobic training five times per week) will be done for eight weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 2 to 3 months old; to have a minimum of 300 grams of weight; to have type 2 diabetes mellitus in diabetic groups; not to have type 2 diabetes mellitus in non-diabetic obese groups; male sex.
Exclusion criteria: movement disabilities.
Intervention groups
1- Aerobic training group (type 2 diabetic models);
2- Aerobic training with vitamin D supplementation group (type 2 diabetic models);
3- Vitamin D supplementation group (type 2 diabetic models);
4- Aerobic training group (non-diabetic obese models);
5- Aerobic training with vitamin D supplementation group (non-diabetic obese models);
6- Vitamin D supplementation group (non-diabetic obese models);
7- Control group (type 2 diabetic models);
8-Control group (non-diabetic obese models);
9- Sham group.
Main outcome variables
Cardiac biomarkers; VEGF-B protein; IGF-1 and Mir-1 genes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220512054832N1
Registration date:2022-06-09, 1401/03/19
Registration timing:prospective
Last update:2022-06-09, 1401/03/19
Update count:0
Registration date
2022-06-09, 1401/03/19
Registrant information
Name
Fatemeh Mazaheri
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 7186
Email address
fatemehmazaheri377@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
The Effect of Eight Weeks Aerobic Training with Vitamin D Supplementation on Cardiac Biomarkers, VEGF-B Protein Levels, IGF-1 and Mir-1 Gene Expression in Cardiomyocytes of Type 2 Diabetic Rats.
Public title
The Effect of Aerobic Training with Vitamin D Supplementation on Cardiomyocytes Gene Expression of Type 2 Diabetic Rats.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2 to 3 months old
To have a minimum of 300 gram of weight
To have type 2 diabetes in diabetic groups
No to have type 2 diabetes in non-diabetic obese groups
Male sex
Exclusion criteria:
Movement disabilities
Age
From 2 months old to 3 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
Random number tables were used for randomization. For this purpose, every 90 rats got a specific number from 1 to 90. Then, using the RAND function of Excel software (Microsoft Corporation, 2019 version), the random number table was produced. Randomly, with closed eyes, one of the excel worksheet cells was clicked on; that number was considered the origin. Because 90 (subjects quantity) is a two-digit number, the first two digits of the numbers listed on the table were read. In case of being in the range of 1 to 90, that number was allocated to the related group. About the group order that is presented in the intervention groups part, the first 10 numbers were allocated to the first group (Aerobic training, type 2 diabetic models). The members of other groups were chosen in this way, too; that is, the second 10 numbers were allocated to the second group, the third 10 numbers to the third group, and so on.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
Research ethics committee of Razi University of Kermanshah
Street address
Razi University, Daneshgah Blvd, Taq-e Bostan Ave
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.RAZI.REC.1401.011
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Cardiac biomarkers
Timepoint
Before & after the intervention.
Method of measurement
Elisa kit (Elabscience Company) with a sensitivity of 18,75 Pg/mL.
2
Description
Vascular Endothelial Growth Factor B
Timepoint
Before & after the intervention.
Method of measurement
Elisa kit (BT-LAB Company) with a sensitivity of 5.01 ng/L.
3
Description
microRNA 1
Timepoint
Before & after intervention.
Method of measurement
Polymerase chain reaction (PCR) method using The Corbett Research Rotor-Gene 6000 (QIAGEN company) and The miScript SYBR Green PCR Kit (QIAGEN company) with a sensitivity of 1.55 ng/ml.
4
Description
Insulin-like growth factor 1
Timepoint
Before & after the intervention.
Method of measurement
Polymerase chain reaction (PCR) method using The Corbett Research Rotor-Gene 6000 (QIAGEN company) and The Transcriptor First Strand cDNA Synthesis Kit (Roche company) with a sensitivity of 1.55 ng/ml.
Secondary outcomes
1
Description
Lipid profile
Timepoint
Before & after the intervention.
Method of measurement
Photometry method using Pars Azmoun company kits. The sensitivity of serum level assay kit for LDL Cholesterol, HDL Cholesterol, Triglyceride, and Glucose equals 12.098 mg/dL, 22.714 mg/dL, 35.087 mg/dL, and 25.497 mg/dL, respectively.
Intervention groups
1
Description
Intervention group one (Aerobic training, type 2 diabetic models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week).
Category
Treatment - Other
2
Description
Intervention group two (Aerobic training with vitamin D supplementation, type 2 diabetic models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week); Receiving vitamin D for eight weeks (5000 IU per week).
Category
Treatment - Other
3
Description
Intervention group three (Vitamin D supplementation, type 2 diabetic models): Receiving vitamin D for eight weeks (5000 IU per week).
Category
Treatment - Other
4
Description
Intervention group four (Aerobic training, non-diabetic obese models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week).
Category
Treatment - Other
5
Description
Intervention group five (Aerobic training with vitamin D supplementation, non-diabetic obese models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week); Receiving vitamin D for eight weeks (5000 IU per week).
Category
Treatment - Other
6
Description
Intervention group six (Vitamin D supplementation, non-diabetic obese models): Receiving vitamin D for eight weeks (5000 IU per week).
Category
Treatment - Other
7
Description
Control group one (type 2 diabetic models): Receiving placebo without aerobic training for eight weeks.
Category
Placebo
8
Description
Control group two (non-diabetic obese models): Receiving placebo without aerobic training for eight weeks.
Category
Placebo
9
Description
Sham group: The subjects of this group are just placed on the treadmill and do not do aerobic training.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
College of Pharmacy of Kermanshah University of Medical Sciences
Full name of responsible person
Zeynab Nadri
Street address
College of Pharmacy, Parastar Blvd, Daneshgah Ave, Shahid Shiroudi Blvd
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
Considering the author's rights, all the data can be utilized.
From where data/document is obtainable
1- Dr. Rastegar Hosseini (rastegar.hoseini@gmail.com).
2- Fatemeh Mazaheri (fatemehmazaheri377@gmail.com).
What processes are involved for a request to access data/document
At first, one will send their request via email. After revision and in case of expediency, in 3-10 working days, the related information will be presented to them.