IRCT | The effect of aerobic and resistance and combined exercise on the expression of mir-15a, muscular strength and endurance in women with type 2 diabetes.

Protocol summary

Study aim: 1- Determining the effect of 8 weeks of selected aerobic, resistance and combined training on miRNA-15a expression in women with type 2 diabetes 2- Determining the effect of 8 weeks of selected aerobic, resistance and combined training on insulin resistance levels in women with type 2 diabetes 3- Determining the effect of 8 weeks of selected aerobic, resistance and combined training on muscle strength and endurance in women with type 2 diabetes 4- Determining the effect of 8 weeks of selected aerobic, resistance and combined training on insulin in women with type 2 diabetes 5- Determining the effect of 8 weeks of selected aerobic, resistance and combined training on cardiorespiratory endurance in women with type 2 diabetes 6- Determining the effect of 8 weeks of selected aerobic, resistance and combined training on body fat percentage in women with type 2 diabetes 7- Determining the effect of 8 weeks of selected aerobic, resistance and combined training on glycosylated hemoglobin levels in women with type 2 diabetes
Design: Control group: having a normal lifestyle, aerobic, resistance and combined exercise (simultaneous aerobic and resistance exercise intervention)
Settings and conduct: These exercises are performed under the supervision of a sports specialist at the Sedighe Tahereh Endocrinology and Metabolism Research Center.
Participants/Inclusion and exclusion criteria: Type 2 diabetes, failure to participate in regular physical activities over the past year, normal diabetic foot , no chest pain , no history of hospitalization, normal foot pulse, no history of diabetic foot ulcers, no history of retinal hemorrhage and Avastin injection
Intervention groups: Aerobic exercises, resistance exercises, combined exercises, control
Main outcome variables: Improve strength, endurance, disease status, cardiorespiratory endurance

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20240721062487N2

Registration date: 2025-02-27, 1403/12/09

Registration timing: registered_while_recruiting

Last update: 2025-02-27, 1403/12/09

Update count: 0
Registration date: 2025-02-27, 1403/12/09

Registrant information: Name

Sahar Ghasemi pour

Name of organization / entity

The universiy of Isfahan

Country

Iran (Islamic Republic of)

Phone

+98 31 3793 2128

Email address

sghasemipr@spr.ui.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-02-19, 1403/12/01
Expected recruitment end date: 2025-03-21, 1404/01/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of aerobic and resistance and combined exercise on the expression of mir-15a, muscular strength and endurance in women with type 2 diabetes.

Public title: Exercise training and type 2 diabetes
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Gender: Female Aged between 30-60 years Not participating in regular physical activity Not using drugs Not using insulin injections Normal examination of the diabetic foot Not chest pain or heaviness or history of hospitalization for heart disease Not history of retinal bleeding and Avastin injection( No history of Proliferative retinopathy) No other underlying disease

Exclusion criteria:

Voluntary withdrawal of participants from continuing the study Having a specific illness that prevents physical activity Occurrence of physical injury Absence of more than three session in sports interventions Pregnancy
Age: From 40 years old to 60 years old
Gender: Female

Phase

N/A

Groups that have been masked

Participant
Care provider
Investigator

Sample size

Target sample size: 80

Randomization (investigator's opinion)

Randomized

Randomization description

Initially, participants are evaluated and ranked according to factors such as muscle strength or endurance and cardiovascular endurance, and subsequently categorized into two groups based on their preferences for specific types of exercise.

Blinding (investigator's opinion)

Double blinded

Blinding description

Participants dose not know of their group assignment. The researcher does not know which group each individual is in. The clinical monitor does not know each participant's group assignment.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Isfahan University of Medical Sciences - Alzahra Research Centers Complex

Street address

Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town

City

Tehran

Province

Isfehan

Postal code

1111111111
Approval date: 2025-02-19, 1403/12/01
Ethics committee reference number: IR.ARI.MUI.REC.1403.244

Health conditions studied

1

Description of health condition studied: Type 2 diabetes mellitus
ICD-10 code: E11.9
ICD-10 code description: Type 2 diabetes mellitus without complications

Primary outcomes

1

Description: miRNA-15a, FBS, HDL, LDL, CREATININE, Muscle endurance and strength
Timepoint: 48 hours before intervention, after intervention for 2 months
Method of measurement: Blood sampling, Dynamometer, Fitness tests

Secondary outcomes

empty

Intervention groups

1

Description: Control group: Having a normal life routine within 8 weeks
Category: Lifestyle

2

Description: Intervention group: Performing aerobic exercise
Category: Lifestyle

3

Description: Intervention group: Performing endurance exercise
Category: Lifestyle

4

Description: Intervention group: Performing combined exercise
Category: Lifestyle

Recruitment centers

1

Recruitment center: Name of recruitment center

Sedigheh Tahereh Education, Therapeutic and Research Complex

Full name of responsible person

Sahar Ghasemipour

Street address

Khoram Ave.

City

Isfahan

Province

Isfehan

Postal code

81876-98191

Phone

+98 31 3335 9933

Email

emrc@mui.ac.ir

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Maryam Kianpour

Street address

Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Ave.

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3668 7153

Fax

+98 31 3669 9398

Email

kianpour@mail.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Isfahan University of Medical Sciences
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

The University of Isfahan

Full name of responsible person

Sahar Ghasemipour

Position

PhD student

Latest degree

Master

Other areas of specialty/work

Physiology

Street address

No.19, Shahid Rahimi Alley, Vahdat Ave.

City

Falavarjan

Province

Isfehan

Postal code

8458174338

Phone

+98 31 3747 4393

Email

Sghasemipr@spr.ui.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Mozhgan Karimifar

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Endocrine and metabolism

Street address

Isfahan University of Medical Sciences, Hezar Jarib Ave.

City

Isfahan

Province

Isfehan

Postal code

1111111111

Phone

+98 913 328 0072

Email

mozhgan_karymyfar@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Mozhgan Karimifar

Position

Associate professor

Latest degree

Subspecialist

Other areas of specialty/work

Others

Street address

Isfahan University of Medical Sciences, Hezar jarib Ave.,

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3668 0048

Email

Mozhgan_karymyfar@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: It can be available upon request from academic researchers, in coordination with the university's Vice President for Research.
When the data will become available and for how long: Three months after publication, the article can be made available at the discretion of the corresponding author and the university's vice president for research.
To whom data/document is available: Only academic researchers can access this information.
Under which criteria data/document could be used: The use of data for statistical analysis and inferential statistics is not permitted.
From where data/document is obtainable: First, coordination must be made with the university's vice president for research and then with the corresponding author.
What processes are involved for a request to access data/document: Official request to the Vice President for Research of the university, administrative correspondence from the Vice President for Research to the corresponding author
Comments

The effect of aerobic and resistance and combined exercise on the expression of mir-15a, muscular strength and endurance in women with type 2 diabetes.