Survey on the synergistic effect of some adiponectin gene polymorphisms in response to aerobic training with two different intensities in middle-aged men with type 2 diabetes
Determining the synergistic effect of adiponectin gene polymorphisms in response to aerobic exercise with different intensities in middle-aged men with type 2 diabetes
Design
A clinical trial of 150 diabetic patients, with control group and two parallel groups with different intensities of aerobic training interventions, randomized
Settings and conduct
In this study, which follows time-series pre and post-test design, 150 patients suffering from type 2 diabetes for more than 12 years and specified genotype of 5 Adiponectin gene polymorphisms are divided into three equal groups; one control and two intervention groups. Intervention groups will do aerobic exercise for 12 weeks and will be evaluated according to the genotype of each individual's response to the aerobic exercise. The study will be conducted at the Diabetes Clinic of Ardabil city.
Participants/Inclusion and exclusion criteria
inclusion criteria: A history of diabetes over 12 years,
Glycated hemoglobin index above 7;
Exclusion criteria: Having a diabetic foot ulcer during the study period,Having neurological and orthopedic disorders, Having severe retinopathy, Having regular physical activity for the past 6 months
Intervention groups
The aerobic exercise intervention groups A (n = 50) and B (n = 50) will do their exercises with the following intensities respectively: 50-65% and 65-80% the peak oxygen uptake. The intervention will last 12 weeks, three sessions per week, and 45 minutes per session. The control group, on the other hand, will not do any regular exercise. The peak oxygen uptake (Vo2peak) will be determined using a modified Balke test on a treadmill.
Main outcome variables
Plasma adiponectin levels,
Five polymorphisms of the adiponectin gene
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200201046326N1
Registration date:2020-07-03, 1399/04/13
Registration timing:retrospective
Last update:2020-07-03, 1399/04/13
Update count:0
Registration date
2020-07-03, 1399/04/13
Registrant information
Name
Elahe Mamashli
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 17 3522 9933
Email address
mamashli.elahe@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2019-08-22, 1398/05/31
Actual recruitment end date
2019-10-22, 1398/07/30
Trial completion date
2020-09-21, 1399/06/31
Scientific title
Survey on the synergistic effect of some adiponectin gene polymorphisms in response to aerobic training with two different intensities in middle-aged men with type 2 diabetes
Public title
The effect of different genotypes of adiponectin gene on diabetes response to exercise
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All diabetic patients who have more than 12 years history of diabetes
Hemoglobin A1c above 7
Age under 65 years old
Exclusion criteria:
People with a history of cardiovascular disease and cancer
Diabetic foot ulcer
Having an amputation
Severe retinopathy
Having neurological and orthopedic disorders
Having regular physical activity for the past 6 months
Age
From 45 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Actual sample size reached:
300
Randomization (investigator's opinion)
Randomized
Randomization description
First, the total sample size of 150 people after screening was determined as the research sample, then using random allocation method, 50 balls were considered for the first intervention group, 50 balls for the second intervention group and another 50 balls for the control group. These balls were placed in a lottery container, then balls were randomly removed from the container without replacement and the sequence created was recorded
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
Ethics Committee in Biomedical Research of Ardabil University of Medical Sciences
Street address
Research Ethics Committee, North side of Ardebil University of Medical Sciences, University Square, University Street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.ARUMS.REC.1397.287
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
Adiponectin
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Adiponectin ELISA kit
2
Description
Five polymorphisms of the adiponectin gene
Timepoint
Before 12 weeks of aerobic exercise
Method of measurement
DNA extraction and pcr method
Secondary outcomes
1
Description
Hemoglobin A1c
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Using the HbA1c kit and the enzyme method (Diazyme)
2
Description
Fasting blood sugar
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Quantitative diagnostic kit (glucose oxidase), by enzymatic photometric method
3
Description
Low-density lipoprotein(LDL)
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Relevant diagnostic kit, Enzymatic method
4
Description
High-density lipoprotein (HDL)
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Relevant diagnostic kit, Enzymatic method
5
Description
Total Cholesterol
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Relevant diagnostic kit, Enzymatic method
6
Description
Triglycerides
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Relevant diagnostic kit, Enzymatic method
7
Description
blood pressure
Timepoint
Before and after 12 weeks of aerobic exercise
Method of measurement
Using a mercury sphygmomanometer
Intervention groups
1
Description
Intervention group 1: In this group, 50 diabetic patients perform low intensity aerobic exercise (65% of maximal oxygen consumption) for 12 weeks, 3 sessions per week. The content of a training session will include dynamic stretching movements in the warm-up (10 minute) and cool-down (7 minute) sections and Jogging for the main section (10 minute).The intensity and type of exercises are designed according to the standards and recommendations of the American College of Sports Medicine.
Category
Lifestyle
2
Description
Intervention group 2: In this group, 50 diabetic patients perform high intensity aerobic exercise (80% of maximal oxygen consumption) for 12 weeks, 3 sessions per week. The content of a training session will include dynamic stretching movements in the warm-up (10 minute) and cool-down (7 minute) sections and Jogging for the main section (10 minute). The intensity and type of exercises are designed according to the standards and recommendations of the American College of Sports Medicine.
Category
Lifestyle
3
Description
Control group: 50 diabetic patients who will not have regular exercise for 12 weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil province diabetes clinic
Full name of responsible person
Dr. Iranparvar
Street address
Diabetes Clinic, End of Ochedkan Alley, Taleghani Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5613677787
Phone
+98 45 3325 6222
Fax
Email
ndiabet@gmail.com
Web page address
http://arddiabetnoor.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Dr. Abolfazl Bezaatpur
Street address
University of Mohaghgegh Ardabili, University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5000
Email
info@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Mohaghegh Ardabili
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahab Buhluli
Street address
Ardabil University of Medical Sciences Administrative Complex, University Square, University Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4776
Fax
+98 45 3353 4757
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
50
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
The University of Mohaghgegh Ardabili
Full name of responsible person
Elahe Mamashli
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University of Mohaghgegh Ardabili, University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 17 3522 9933
Email
mamashli.elahe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Elahe Mamashli
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, University Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 17 3522 9933
Email
Mamashli.elahe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Elahe Mamashli
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University of Mohaghgegh Ardabili, University Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 17 3522 9933
Email
Mamashli.elahe@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data related to the distribution of the 5 polymorphisms studied will be shared.
When the data will become available and for how long
Start of access period 6 months after publication of Results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers in this field who have a larger statistical sample than our research
From where data/document is obtainable
Elaheh Mamashli, PhD student of Mohaghegh Ardabili University,
Mamashli.elahe@gmail.com
09115327323
What processes are involved for a request to access data/document
After receiving the request, the data will be sent after informing the other participants in this research