Assessing the impact of two selected exercise training on the alterations in the expression of miRNA-25, miRNA-93, and some physiological parameters in children diagnosed with type 1 diabetes.
The primary objective of this study is to assess the impact of two chosen resistance and aerobic training techniques on the expression levels of miRNA-25, miRNA-93, and various physiological parameters in children diagnosed with type 1 diabetes.
Design
This clinical trial will be carried out with parallel groups and will utilize randomization through a random number table involving 30 adolescents diagnosed with type 1 diabetes. This study will not implement blinding, and participants will be assigned to two groups—resistance and aerobic exercise—based on the odd and even values of the table, with 15 individuals allocated to each group.
Settings and conduct
This research will take place at the University of Isfahan, where participants will be allocated to the intervention groups at random, and no blinding will be implemented. The exercise regimen will consist of three sessions each week, lasting between 30 to 90 minutes per session, over a duration of eight weeks in the gym.
Participants/Inclusion and exclusion criteria
The inclusion criteria: participants must not have participated in regular physical activities during the preceding year and must have a diagnosis of type 1 diabetes. The exclusion criteria for the study encompassed voluntary withdrawal by participants, physical injuries, the existence of other particular medical conditions, and the absence from more than three sessions of exercise interventions.
Intervention groups
The intervention groups comprised individuals engaging in aerobic exercises and another group involved in resistance exercises over a duration of 8 weeks, with 3 sessions each week.
Main outcome variables
Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250908067184N1
Registration date:2025-11-10, 1404/08/19
Registration timing:prospective
Last update:2025-11-10, 1404/08/19
Update count:0
Registration date
2025-11-10, 1404/08/19
Registrant information
Name
Niyayesh Gheisari
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3232 0846
Email address
niyayeshgheisari367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-06, 1404/09/15
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the impact of two selected exercise training on the alterations in the expression of miRNA-25, miRNA-93, and some physiological parameters in children diagnosed with type 1 diabetes.
Public title
Assessing the impact of two chosen exercise techniques on alterations in specific biomarkers and physiological indicators in children diagnosed with type 1 diabetes.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
An absence of participation in routine physical activities during the preceding year
Type 1 diabetes identified by a medical expert
Being within the age range of 12 to 15 years
Exclusion criteria:
Participants' free withdrawal from further interventions
Physical injury during interventions
Having other specific diseases
Absence of more than 3 sessions in designated exercise interventions
Age
From 12 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be allocated randomly into two experimental groups by utilizing a random number table. A total of 15 individuals will be chosen for the resistance training group, while another 15 individuals will be selected for the aerobic training group.
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
University of Isfahan Research Ethics Committee
Street address
University St., University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Approval date
2025-09-13, 1404/06/22
Ethics committee reference number
IR.UI.REC.1404.149
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Lipid Profile
Timepoint
Prior to the intervention and following 8 weeks of exercise interventions
Method of measurement
Measurements are conducted utilizing specialized kits.
2
Description
Insulin
Timepoint
Prior to the intervention and following 8 weeks of exercise interventions
Method of measurement
The assessment of insulin levels is conducted through the utilization of immunoassay-based insulin analysis kits.
3
Description
Blood sugar
Timepoint
Prior to the intervention and following 8 weeks of exercise interventions
Method of measurement
Blood glucose levels are assessed through the use of blood glucose kits and the photometric technique.
4
Description
miRNA-25
Timepoint
Prior to the intervention and following 8 weeks of exercise interventions
Method of measurement
The levels of miRNA-25 are extracted from blood serum using special kits and a real-time PCR device.
5
Description
miRNA-93
Timepoint
Prior to the intervention and following 8 weeks of exercise interventions
Method of measurement
The levels of miRNA-93 are extracted from blood serum using special kits and a real-time PCR device.
6
Description
Cardiorespiratory endurance
Timepoint
Prior to the intervention and following 8 weeks of exercise interventions
Method of measurement
The participants' cardiorespiratory endurance will be determined using a 20-meter shuttle run test.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group 1: Participants in this group will perform a selected aerobic exercises for 8 weeks.
Category
Lifestyle
2
Description
Intervention Group 2: Participants in this group will partake in a resistance training regimen utilizing bodyweight exercises for a period of 8 weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Isfahan
Full name of responsible person
Vazgen Minasian
Street address
University street
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2369
Email
v.minasian@spr.ui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Babak Saffari
Street address
University street
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2039
Email
b_saffari@ase.ui.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 Isfahan
Proportion provided by this source
100
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 Isfahan
Full name of responsible person
Niyayesh Gheisari
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
University street
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3232 0846
Email
niyayeshgheisari367@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Vazgen Minasian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
University St.
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3627 8066
Email
v.minasian@spr.ui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Niyayesh Gheisari
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Physiology
Street address
University St.
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3232 0846
Email
niyayeshgheisari@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
Not applicable
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
No - There is not a plan to make this available
Title and more details about the data/document
The data file will only be made available to academic researchers after obtaining permission from the university's research director.
When the data will become available and for how long
Access to data will commence three months following the publication of the results in an article format.
To whom data/document is available
Only researchers working at universities and scientific centers will have access to the data.
Under which criteria data/document could be used
The data will be accessible to researchers exclusively for the purposes of research studies and statistical analyses.
From where data/document is obtainable
To acquire data, kindly reach out to or corresponding author of published article, following the receipt of authorization from the university's research director.
What processes are involved for a request to access data/document
To receive data, permission from the university's research director is required, and the author responsible for the article will provide the data within 2 weeks.