Interactional and separate effects of aerobic training and vitamin D supplementation on genes expression of inflammation and oxidative stress in men with type 2 diabetes
The aim of this study was to investigate the interactional and separate effects of aerobic training and vitamin D supplementation on genes expression of inflammation and oxidative stress in men with type 2 diabetes
Design
For this purpose, 40 men with type 2 diabetes will be randomly divided into 4 groups: aerobic training + vitamin supplementation, aerobic training, vitamin D supplementation and control, as well as vitamin D intake (about 50,000 IU= 1/25 mg per week for eight weeks); Or it will be a placebo. The aerobic training protocol includes 20 to 40 minutes of aerobic exercise with an intensity of 60 to 75% of the maximum heart rate, 3 times a week for eight weeks.
Settings and conduct
This study was a clinical trial on the aerobic training and vitamin D supplementation on genes expression of inflammation and oxidative stress in men with type 2 diabetes under the supervision of HALABJA University. Pre-test and post-test will be performed.
Participants/Inclusion and exclusion criteria
Non-insulin dependent type 2 diabetes; HbA1C above 6; no antioxidants; multivitamin and polyphenol supplements in the last three months; having index body mass (25 to 29.99 kg / m2)
Intervention groups
Aerobic training (placebo); Vitamin D supplementation (no AT); Aerobic training with vitamin D supplements (AT+Vit D); and Control (placebo+no AT)
Main outcome variables
Vitamin D; genes expression of inflammation and Oxidative stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052151N1
Registration date:2021-09-01, 1400/06/10
Registration timing:registered_while_recruiting
Last update:2021-09-01, 1400/06/10
Update count:0
Registration date
2021-09-01, 1400/06/10
Registrant information
Name
Rastegar Hoseini
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3423 3267
Email address
r.hoseini@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interactional and separate effects of aerobic training and vitamin D supplementation on genes expression of inflammation and oxidative stress in men with type 2 diabetes
Public title
The effect of aerobic exercise and vitamin D supplementation on inflammation in men with type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering non-insulin dependent type 2 diabetes
Fasting blood sugar above 126
Do not take antioxidants and multivitamin and polyphenol supplements in the last three months
Body mass index (25 to 29.99 kg/per square meter)
HbA1C above 6
Exclusion criteria:
Changes in the amount and type of medication taken, physical activity and diet during the study period
Fasting blood sugar greater than 200 mg / dL
LDL greater than 160 mg / dL
Having Heart disease, renal failure, liver
Age
From 30 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Razi University of Kermanshah
Street address
No. 8, University Blvd, Kermanshah Province, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.RAZI.REC.1400.044
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Lipid profile
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
2
Description
Glycemic indexes
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
3
Description
Anthropometric indicators
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
The quantitative measurement tools
4
Description
Genes expression of inflammation
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
5
Description
Oxidative stress
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Aerobic training + vitamin D supplementation group: The aerobic training + vitamin D supplementation Intervention will be consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks online and vitamin D supplementation will be receiving vitamin D (∼50000 IU • week for eight weeks) receiving vitamin D (about 50,000 IU per week for 8-weeks).
Category
Lifestyle
2
Description
Intervention group 2: Aerobic training group: Aerobic training consists of 20 to 40 minutes of aerobic exercise with an intensity of 60 to 75 % of maximum heart rate, 3 times a week for eight weeks online.
Category
Lifestyle
3
Description
Intervention group 3: Vitamin D supplementation group: Vitamin D supplementation includes receiving vitamin D (∼50000 IU • week for eight weeks).
Category
Lifestyle
4
Description
Control group: Receiving placebo (containing paraffin made by Zahravi Pharmaceutical Company of Iran which is similar to vitamin D supplement in terms of shape, color, smell and taste) and no aerobic training for eight weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center
Full name of responsible person
Rastegar Hoseini
Street address
Faculty of Physical Education and Sports Sciences, Kermanshah, No. 9, Razi University Blvd.