Comparison of the effect of resistance and aerobic training on the expression of microRNA-192 and serum levels of GLP-1, GABA, Pentraxin3 and HbA1c in children with type 1 diabetes
Evaluation of the effect of exercise training on effective biomarkers in type 1 diabetes
Design
The clinical trial consists of four groups of 15 volunteers to compare the effect of the two training methods.
Settings and conduct
Exercises will be done at home under the supervision of a exercise physiologist. At the beginning and end of the eight-week training period, blood samples and physiological measurements will be performed to evaluate the effect of exercise.
Participants/Inclusion and exclusion criteria
Having type 1 diabetes; Lack of regular exercise in the last year; No physical injury or limited mobility
Intervention groups
Regular exercise for eight weeks
Main outcome variables
Helping patients with type 1 diabetes recover by recognizing the beneficial effects of exercise
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200326046861N2
Registration date:2022-05-14, 1401/02/24
Registration timing:prospective
Last update:2022-05-14, 1401/02/24
Update count:0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Vazgen Minasian
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 8066
Email address
v.minasian@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of resistance and aerobic training on the expression of microRNA-192 and serum levels of GLP-1, GABA, Pentraxin3 and HbA1c in children with type 1 diabetes
Public title
Effect of exercise on some serum factors in children with type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 diabetes at least one year after diagnosis
Exclusion criteria:
Diseases that prevent people from participating in exercising activities.
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 of Isfahan University
Street address
University of Isfahan, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.UI.REC.1400.115
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
Investigation of changes in microRNA-192
Timepoint
Before and after the eight-week period of exercise
Method of measurement
PCR
2
Description
Evaluation of changes in GLP-1 protein in serum
Timepoint
Before and after the eight-week period of exercise
Method of measurement
ELISA
3
Description
Evaluation of changes in GABA protein in serum
Timepoint
Before and after the eight-week period of exercise
Method of measurement
ELISA
4
Description
Evaluation of changes in Pentraxin3 protein in serum
Timepoint
Before and after the eight-week period of exercise
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: It consists of a group of 15 members with a resistance exercise protocol (exercises at home, with minimal exercise equipment and involving different muscle groups in the body) which is performed for 8 weeks and 3 days a week for 1 hour. Subjects will not use any medications or dietary supplements during the eight weeks of exercise other than the medications prescribed by their physician.
Category
Lifestyle
2
Description
Intervention group 2: It consists of a group of 15 members with aerobic exercise protocol (exercises at home, with minimal exercise equipment) which is performed for 8 weeks and 3 days a week for 1 hour. Subjects will not use any medications or dietary supplements during the eight weeks of exercise other than the medications prescribed by their physician.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossien Children’s Hospital
Full name of responsible person
Silva Hovsepian
Street address
Metabolic Liver Disease Research Center, Imam Hossien Children’s Hospital, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 129 4269
Email
silvahovsepsecret@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Street address
University of Isfahan, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 913 202 0396
Email
v.minasian@spr.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
University of Isfahan
Full name of responsible person
Maryam Nazari
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Isfahan, Azadi square, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8174673441
Phone
+98-313-7932003-7
Email
m.nazari1320@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Maryam Nazari
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Isfahan, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Email
m.nazari1320@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Maryam Nazari
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Isfahan, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Email
m.nazari1320@yahoo.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
Yes - There is 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
All blood and physiological data of individuals can be shared after they were made anonymous.
When the data will become available and for how long
The start of the access period will be 6 months after the publication of the results.
To whom data/document is available
For researchers and scientific journals
Under which criteria data/document could be used
Researchers and scientific journals can access the data if they make their reports in coordination with us and mention the names of the main authors of this study in their report.
From where data/document is obtainable
Applicants can contact the corresponding or other authors via email.
What processes are involved for a request to access data/document
Applicants can submit their application via email. Information will be provided to them in case of authors’ agreement.