The Effect of a Multi Component Exercise Program on Cognitive Function in Women with Type 2 Diabetes, with a Special Focus on Serum Levels and Geno typing of Selected cytokine TNF alpha and IL-10 Polymorphisms
Diabetes causes an increase in inflammatory cytokines and disruption in cognitive function and dementia of people, that exercise through different mechanisms reduces risk factors related to diabetes, reduces inflammatory cytokines and improves cognitive function.
Design
The clinical trial will have two groups of sports intervention and control, without blinding, randomized on 100 women with type 2 diabetes.The samples will be determined by the random block method with blocks of 4 and using the random number table of the random allocation software.
Settings and conduct
The field of the current study will be sports training and counseling for women with type 2 diabetes. After being diagnosed by telephone, the subjects will appear fasting in the pre- and post-test stages at Tarbiat Modares University. Exercises will be presented to the exercise group in the form of booklets and educational videos, and the coach will contact the patients of the exercise group every week to follow up on the exercises. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Has type 2 diabetes
Age in the range of 50-75 years
Glaciated hemoglobin greater than 6.5
Absence of heart and joint problems so that they are not able to perform the exercise protocol.
Not taking nerve pills and sleeping pills
Intervention groups
Out of 100 subjects, 50 people are in the control group, who do not do any sports activities, and 50 people are in the sports intervention group,who will do sports exercises for 3 months according to the protocol.
Main outcome variables
Serum levels and genotyping of cytokines Tumour necrosis factor α and Interleukin 10, cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220702055347N1
Registration date:2023-06-20, 1402/03/30
Registration timing:prospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Afsaneh Jamali
Name of organization / entity
Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 0000
Email address
jamaliafsaneh@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a Multi Component Exercise Program on Cognitive Function in Women with Type 2 Diabetes, with a Special Focus on Serum Levels and Geno typing of Selected cytokine TNF alpha and IL-10 Polymorphisms
Public title
The Effect of a Multi Component Exercise Program on Cognitive Function of Women with Type 2 Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood glucose more than 7 mmol/L
Hemoglobin A1c more than 6.5
Do not have cognitive function, heart and joint problems
People with type 2 diabetes
Be in the desired age range
Exclusion criteria:
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by the random block method with blocks of 4 and using the random number table of the random allocation software. Blocking and allocation sequence will be done for concealment by a person not involved in the research (allocation concealment). The allocation ratio of the samples will be one to one and they will be placed in two sports intervention and control groups. Then, based on the obtained blocks and according to the allocation sequence, the multiple exercise training program will be given to the exercise intervention group. Blinding will not occur in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IR.MODARES.REC.1400.293
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Interleukin 10 genotyping
Timepoint
Before and after 3 months interventions
Method of measurement
Restriction fragment length polymorphism
2
Description
Tumour necrosis factor α genotyping
Timepoint
Before and after 3 months interventions
Method of measurement
Restriction fragment length polymorphism
Secondary outcomes
1
Description
Tumor necrosis factor alpha cytokine
Timepoint
Before and after 3 months intervention
Method of measurement
Enzyme-linked immunosorbent assay
2
Description
Interleukin 10 cytokine
Timepoint
Before and after 3 months intervention
Method of measurement
Enzyme-linked immunosorbent assay
3
Description
Executive function
Timepoint
Before and after 3 months intervention
Method of measurement
Trail Making Test
4
Description
Respiratory and cardiovascular system, blood circulation and muscle
Timepoint
Before and after 3 months intervention
Method of measurement
6-Minute Walk Test
5
Description
Body Mass Index
Timepoint
Before and after 3 months intervention
Method of measurement
Weight in kilograms divided by the square of height in meters
Intervention groups
1
Description
"Intervention group": A 3-month multi component exercise intervention consisting of stretching, resistance, dual task and balance exercises will be implemented. The intensity of aerobic exercises will be kept 40 to 60 maximum reserve heart rate and the number of sessions will increase from 3 to 5 per week.
Category
Lifestyle
2
Description
"Control group":No intervention will be carried out in this group, and patients will continue their usual routine before the pre-test.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Research Institute
Full name of responsible person
Azam Koohkan
Street address
QF49+75J,Shahid Sayad Shirazi Highway, Sanyaat Boulevard, South Golzar St., Neda Alley, next to Ghaem Mosquem,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 2356 2000
Fax
+98 21 2230 6481
Email
info@royaninstitute.org
2
Recruitment center
Name of recruitment center
Endocrinoligy and Metabolism Research Institute
Full name of responsible person
Hossein Adib
Street address
P9FM+6W3, Jalal Al Ahmad Highway, next to Dr. Shariati Hospital, Endocrinology and Metabolism Research Institute,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1411713139
Phone
+98 21 8863 1298
Email
emrc@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Dr. Mahdieh Molanouri Shamsi
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
molanouri@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University of Tehran
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
Cognitive Sciences and Technology Council
Full name of responsible person
Majid Nili Ahmadabadi
Street address
Vali Asr St. (AJ), above Niayesh Crossroad, Ostad Daryabandari St. (West Armaghan), No. 3 (former building of the Supreme Council of Iranians Abroad), 3rd floor,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1967875319
Phone
+98 21 2266 0770
Email
research.project@cogc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Sciences and Technology Council
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
Tarbiat Modares University of Tehran
Full name of responsible person
Dr.Mahdieh Molanouri Shamsi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Nasr Bridge,Jalal Al Ahmad St,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4683
Email
molanouri@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Mahdie Molanori Shamsi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Nasr Bridge,Jalal Al Ahmad St,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
molanouri@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Afsaneh Jamali
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Nasr Bridge,Jalal Al Ahmad St,Tehran,Iran
City
tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
jamali.afsaneh@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data related to the main outcome can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
People approved by the supervisor
Under which criteria data/document could be used
For scientific purposes
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document
E-mail correspondence with the supervisor
molanouri@modares.ac.ir