The Effect of Home -based Combined Exercise Training on Serum Level of Interleukin 17 Cytokine and its Relationship with Cognitive Function in Women with Type 2 Diabetes.
Investigating the effect of a combined exercise course at home on the levels of the cytokine interleukin 17 and its relationship with cognitive function in women with type 2 diabetes
Design
The clinical trial has a control group without any intervention of 50 people, an intervention group of 50 people, phase 4 on 100 patients, sealed envelopes are used for randomization.
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 be present at Tarbiat Modares University of Tehran fasting in the pre- and post-examination stages. Exercises will be presented to the training group in the form of booklets and educational videos, and the trainer will contact the patients of the training group every week to follow up on the exercises. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People with type 2 diabetes
Age in the range of 50-75 years
HbA1c greater than 6.5
Exclusion criteria:
Absence of heart and joint problems so that they are not able to perform the exercise protocol.
Not taking nerve pills and sleeping pills
Not taking insulin
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
Cytokine interleukin 17 and cognitive function and physical fitness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220927056048N1
Registration date:2023-07-20, 1402/04/29
Registration timing:registered_while_recruiting
Last update:2023-07-20, 1402/04/29
Update count:0
Registration date
2023-07-20, 1402/04/29
Registrant information
Name
Samaneh Aghamohammadi
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 4403 9730
Email address
samaneaghamohammadi@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 Home -based Combined Exercise Training on Serum Level of Interleukin 17 Cytokine and its Relationship with Cognitive Function in Women with Type 2 Diabetes.
Public title
The Effect of Exercise on the Cytokine Interleukin-17 and Cognitive Function
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood glucose more than 7 mmol/L
hba1c more than 6.5
Do not have heart and joint problems
People with type 2 diabetes
Be in the desired age range
Exclusion criteria:
Severe orthopedic problem
Severe breathing problems
Severe cardiovascular disease
Dementia
Central nervous system disorder
A special diet such as vegetarianism
Doing regular exercise during the last 6 months
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. 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
Working group of ethics committee in research of Tarbiat Modares University
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2022-05-28, 1401/03/07
Ethics committee reference number
IR.MODARES.REC.1401.046
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
Cytokine factor interleukin 17
Timepoint
Before and after 3 months interventions
Method of measurement
Enzyme-linked immunosorbent assay
Secondary outcomes
1
Description
Executive function
Timepoint
Before and after 3 months intervention
Method of measurement
Trail Making Test
2
Description
Respiratory and cardiovascular system, blood circulation and muscle
Timepoint
Before and after 3 months intervention
Method of measurement
6-Minute Walk Test
3
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 Kohkan
Street address
Golzar ST
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2000
Fax
Email
inf@royan.org
Web page address
https://royandiabetes.org
2
Recruitment center
Name of recruitment center
Endocrine and Metabolism Research Institute
Full name of responsible person
Hossein Adib
Street address
Enghelab street-
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8880 8005
Email
dmclinic@tums.ac.ir
Web page address
https://emri.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Dr. Mahdieh Melanori Shamsi
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
Email
pres@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
10
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 Molanori Shamsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4683
Fax
+98 21 8288 3617
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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4683
Email
molanouri@modares.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Samaneh Aghamohammadi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
Email
samaneaghamohammadi@modares.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
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 the purpose of additional research in the field of study
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