Effect of combined exercise training on inflammatory factors and levels of hormones associated with blood glucose homeostasis in pediatric type 1 diabetes
Effect of combined exercise training on inflammatory factors and levels of hormones associated with blood glucose homeostasis in pediatric type 1 diabetes
Design
In this research, 35 child With type 1 diabetes voluntarily will be divided into two groups; 20 people in experimental and 15 people in control group.
Settings and conduct
The present study is a semi-experimental study among the child With type 1 diabetes of city of Rasht for 16 weeks. Blood sampling is performed after 12 hours of fasting and before and after 16 weeks of concurrent training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having age ranges of 8-15 years, A1c≥7, Pediatric type 1 diabetes, No regular exercise
Exclusion criteria: more than three session absence from the training
Intervention groups
Intervention group: Combined training group. Aerobic training: sixteen weeks, three times per week . Aerobic exercises were performed with an intensity of 50-75% of maximum heart rate, pilates exercises, 3 set, 6-12 repeat and training using body weight with 20 minuets.
Control group: Without intervention
Effect of combined exercise training on inflammatory factors and levels of hormones associated with blood glucose homeostasis in pediatric type 1 diabetes
Public title
Effect of combined exercise training in pediatric type 1 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having age ranges of 8-15 years
A1c≥7
Pediatric type 1 diabetes
No regular exercise
Exclusion criteria:
More than three session absence from the training
Age
From 8 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were divided into 2 groups (one control group and one experimental groups) using the simple random method. This sampling will be done based on the red and blue balls inside the box that are randomly taken by the subjects (Red Orb and the Blue Orb of the experimental 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
Ethics Committee of Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2019-07-19, 1398/04/28
Ethics committee reference number
IR.IAU.RASHT.REC.1398.011
2
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.IAU.RASHT.REC.1396.168
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
IL-1B
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
2
Description
High-sensitivity C-reactive Protein (hs-CRP)
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
3
Description
IGF-1
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
4
Description
Growth hormone
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
5
Description
Cortisol
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
6
Description
HbA1c
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
7
Description
Fast blood sugar
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
8
Description
Complete Blood Count (CBC)
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and after the end of interventions
Method of measurement
Using questionnaire
2
Description
Body composition
Timepoint
Before and after the end of interventions
Method of measurement
Using weight, body mass index, waist to hip ratio and fat percent
3
Description
Physical fitness
Timepoint
Before and after the end of interventions
Method of measurement
Using measurement of aerobic power ,anaerobic , balance ,Flexibility and hand grip
4
Description
Blood pressure
Timepoint
Before and after the end of interventions
Method of measurement
Using the blood pressure device
Intervention groups
1
Description
Intervention group: Combined training group. Aerobic training: sixteen weeks, three times per week . Aerobic exercises were performed with an intensity of 50-75% of maximum heart rate ,pilates exercises, 3 set, 6-12 repeat and training using body weight with 20 minuets.
Category
Lifestyle
2
Description
Control group: Without intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Children's Hospital
Full name of responsible person
Dr setila dalili
Street address
Shahid Siadati Avenu, Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3336 9070
Email
marzieh.nazari.v@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali delpasand
Street address
Islamic Azad University, Rasht Brunch
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Marzieh Nazari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
marzieh.nazari.v@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Nazari
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
marzieh.nazari.v@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available