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Investigating the effect of Pilates training on serum levels of Irisin, Ghrelin, lipid profile and appetite in women with type 2 diabetes

Protocol summary

Study aim
Investigating the effect of 12-week Pilates exercises on serum Irisin level, Ghrelin level, lipid profile and appetite in women with type 2 diabetes
Design
A clinical trial is randomized with a control group and an intervention group, with parallel groups, a single blind which is performed on 30 people. The online randomization site kitset.ir/numbers/random is used for randomization.
Settings and conduct
Place of the study: Jenan Diabetes Center, Najaf Abad. Study population: Women with type 2 diabetes (members of Jenan Diabetes Association). Single blind test: Participants were blinded, people in the control group did not know about the exercises in the exercise group, and the exercise group did not know about the control group. The subjects in both groups are blind. Sampling is random, and the sampling method is semi-experimental.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 35 to 55 years old- fasting blood sugar equal to or more than 126 to 250, history of at least one-year diabetes, use of oral medicine, ability to do exercise, use of oral diabetes medicine. Exclusion criteria: having back pain and neck pain - using injectable insulin - exercising regularly
Intervention groups
Intervention group: It includes 15 women with type 2 diabetes who meet the inclusion criteria and undergo 12-week Pilates training, 3 sessions per week, 50 minutes per each session, with an intensity of 70 to 80% of the maximum heart rate. Control group: There is no intervention for them.
Main outcome variables
Irisin, Ghrelin, Lipid profile and appetite

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230628058611N1
Registration date: 2023-10-12, 1402/07/20
Registration timing: prospective

Last update: 2023-10-12, 1402/07/20
Update count: 0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Azam Talebi Najafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4262 9350
Email address
a.talebi98@shu.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-03-06, 1402/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Pilates training on serum levels of Irisin, Ghrelin, lipid profile and appetite in women with type 2 diabetes
Public title
The effect of Pilates training on type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age: Between 35 to 55 years old Fasting Blood Sugar: Equal to or more than 126 to 250 History: At least one year history of Diabetes Ability to do exercise Use of oral medication
Exclusion criteria:
Doing exercise regularly Having back pain and neck pain Use of injectable insulin
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
How to randomize: The online random number generation site at the address kitset.ir/numbers/random was used and the no duplicate numbers were ticked and 15 numbers were selected among 30 subjects and numbers of 15,9,28,8,16,13,12,30,11,3,21,29,26,5,1 were placed in the test group and numbers of 14,6,18,7,4,27,20,10,2,23,17,19,25,24,22 were placed in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant: People in the control group do not know about the exercises of the training group, and the training group does not know about the control group. The subjects are blind in both groups. Coach: He doesn't know about the training group. The outcome evaluator: He doesn't know about being two groups and the protocol of exercise. Data analyzer: It has no relationship with subjects, coach, and training protocol
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Najafabad Azad University
Street address
Najafabad Azad University, University Boulevard, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2022-06-30, 1401/04/09
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1401.042

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Diabetes mellitus type 2

Primary outcomes

1

Description
Irisin
Timepoint
Before and 48 hours after the study
Method of measurement
Laboratory kits

2

Description
Ghrelin
Timepoint
Before and 48 hours after the study
Method of measurement
Laboratory kits

3

Description
Low density lipoprotein
Timepoint
Before and 48 hours after the study
Method of measurement
Laboratory kits

4

Description
High density lipoprotein
Timepoint
Before and 48 hours after the study
Method of measurement
Laboratory kits

5

Description
Cholesterol
Timepoint
Before and 48 hours after the study
Method of measurement
Laboratory kits

6

Description
Triglyceride
Timepoint
Before and 48 hours after the study
Method of measurement
Laboratory kits

7

Description
Amount of appetite
Timepoint
Before and 48 hours after the study
Method of measurement
(Questionnaire) Visual analog scale

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: It includes 15 women with type 2 diabetes (members of Jenan Diabetes Association) who meet the inclusion criteria of the study and undergo 12-weeks Pilates training, 3 sessions per week, 50 minutes per each session, with an intensity of 70 to 80% of the maximum heart rate.
Category
Rehabilitation

2

Description
Control group: It includes 15 women with type 2 diabetes (members of Jenan Diabetes Association) who meet the inclusion criteria of the study and this group continues their daily life and does not have any special plan.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Jenan Diabetes Center
Full name of responsible person
Azam Talebi Najafabadi
Street address
No. 35, Abdulahi Deadend, Riyazi St., Shariati St.
City
Najafabad
Province
Isfehan
Postal code
8513677891
Phone
+98 21 4262 9350
Email
talebiazam26 @gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdi Rafiei
Street address
Najafabad Azad University, University Boulevard, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Email
INFO @ IAUN.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Najafabad Azad University
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
Islamic Azad University of Najafabad
Full name of responsible person
Azam Talebi Najafabadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
No. 35, Abdulahi Deadend, Riyazi St., Shariati St.
City
Najafabad
Province
Isfehan
Postal code
8513677891
Phone
+98 31 4262 9350
Email
talebiazam26@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam Talebi Najafabadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
No. 35,Abdulahi Deadend, Riyazi St., Shariati St.
City
Najafabad
Province
Isfehan
Postal code
8513677891
Phone
+98 31 4262 9350
Email
talebiazam26@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam Talebi Najafabadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 35, Abdullahi Deadend, Riyazi St., Shariati St.
City
Najafabad
Province
Isfehan
Postal code
8513677891
Phone
0098 31 4262950
Email
talebiazam26@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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