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Effect of Different Intensities of Aerobic Exercise Combined with Resistance Exercise and Cinnamon Consumption on Meteorin-like protein (Metrnl), Irisin and Inflammatory Factors in Diabetic Women

Protocol summary

Study aim
This study aimed to investigate the impact of varying intensities of aerobic exercise, resistance exercise, and cinnamon consumption on Metrn-like protein (Metrnl), irisin, and inflammatory markers in diabetic women.
Design
54 women with type 2 diabetes from Nowshahr were randomly divided into six groups: Control+placebo, moderate intensity aerobic exercise + resistance exercise, high intensity aerobic exercise + resistance exercise, cinnamon, moderate intensity aerobic exercise + resistance exercise + cinnamon and high intensity aerobic exercise + resistance training + cinnamon. Training groups do aerobic-resistance exercises five times a week for eight weeks. The cinnamon supplement consuming groups took 1000 mg daily for eight weeks after breakfast and lunch.
Settings and conduct
Intervention Research, Noshahr City, the research site is Takhti Sports Club, which has already been coordinated. In this research, people who work with subjects are blinded.
Participants/Inclusion and exclusion criteria
Having type 2 diabetes (people who had a history of fasting glucose higher than 126 mg/dL with HbA1c higher than 6.5% and were under the supervision of a doctor at the time of the research). Not having cardiovascular diseases. Not having musculoskeletal diseases. Not having metabolic diseases limiting sports activity. Not suffering from high blood pressure disease. Not having a history of regular sports activity in the last six months. They did not use insulin. Age range in the range of 50-65 years.
Intervention groups
Different Intensities of Aerobic Exercise Combined with Resistance Exercise and Cinnamon Consumption
Main outcome variables
Effect of training with cinnamon on indexes such as: Metrnl, Irisin, PGC-1α, TNF-α,TGF-β , IL-2 , IL-10 , HbA1C.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140415017288N12
Registration date: 2024-09-07, 1403/06/17
Registration timing: registered_while_recruiting

Last update: 2024-09-07, 1403/06/17
Update count: 0
Registration date
2024-09-07, 1403/06/17
Registrant information
Name
Ahmad Abdi
Name of organization / entity
Ayatollah Amoli Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 11 4321 7126
Email address
a.abdi@iauamol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-09-15, 1403/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Different Intensities of Aerobic Exercise Combined with Resistance Exercise and Cinnamon Consumption on Meteorin-like protein (Metrnl), Irisin and Inflammatory Factors in Diabetic Women
Public title
Effect of Exercise and Cinnamon on Diabetic Women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes (people with a history of more than twice the fasting glucose above 126 mg / dL with HbA1c above 6.5% and under the supervision of a physician at the time of the study). Subjects were asked to complete a questionnaire of readiness to start sports. Lack of cardiovascular, Lack of musculoskeletal, Lack of metabolic diseases limited exercise, lack of high blood pressure, lack of a history of regular exercise during the past six months, lack of insulin. Age range in the range of 35-50 years. Inactive lifestyle (exercise less than 1 hour per week). Consent to participate in the study.
Exclusion criteria:
Use of drugs that lower blood pressure and blood lipids Exclusion criteria included a history of serious diabetic complications (such as proliferative diabetic retinopathy, stage 3 or subsequent overt nephropathy, diabetic ketoacidosis or severe diabetic neuropathy). fasting glucose above 270 mg / dL malaise Hereditary absorption of glucose and galactose or renal glycosuria. Detection of other underlying diseases during the implementation of the protocol, such as cardiopulmonary problems and musculoskeletal disorders during exercise that prevent the performance of the activity.
Age
From 35 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, subjects are selected Simple randomization by random allocation rule. After determining the sample size, they will be equally divided into 6 groups (Control, moderate-intensity aerobic training + resistance training, high-intensity aerobic training + resistance training, cinnamon, moderate-intensity aerobic training + resistance training + cinnamon and high-intensity aerobic training + resistance training + cinnamon). Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in the intervention groups or placebo, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each capsule will contain 500 mg of cinnamon powder, and each subject will receive one capsule in the morning immediately after breakfast and one capsule after lunch, and the control and exercise groups will receive the same amount of placebo. Starch is used as a placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Ayatollah Amoli Branch
Street address
Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road.
City
Amol
Province
Mazandaran
Postal code
3358-461514
Approval date
2024-07-12, 1403/04/22
Ethics committee reference number
IR.IAU.AMOL.REC.1403.099

Health conditions studied

1

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

Primary outcomes

1

Description
Effect of training and cinnamon supplementation on Metrnl
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

2

Description
Effect of training and cinnamon supplementation on Irisin
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

3

Description
Effect of training and cinnamon supplementation on PGC-1α
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

4

Description
Effect of training and cinnamon supplementation on TNF-α
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

5

Description
Effect of training and cinnamon supplementation on TGF-β
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

6

Description
Effect of training and cinnamon supplementation on IL-2
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

7

Description
Effect of training and cinnamon supplementation on IL-10
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: We will consider this group as the control group.
Category
Placebo

2

Description
Intervention group 2: Moderate-intensity aerobic training+resistance training group (In this group, for 8 weeks, five session/weeks, the training start with 10 minutes of warm-up. Aerobic exercise with an intensity of 50% VO2max is performed along with TRX exercise. The total energy of exercise is about 400 kcal).
Category
Treatment - Other

3

Description
Intervention group 3: High-intensity aerobic training+resistance training group (In this group, for 8 weeks, five session/weeks, the training start with 10 minutes of warm-up. Aerobic exercise with an intensity of 80% VO2max is performed along with TRX exercise. The total energy of exercise is about 400 kcal).
Category
Treatment - Other

4

Description
Intervention group 4: Cinnamon supplementation group (in this group eat 1000 mg of cinnamon supplementation for eight weeks Twice a day after breakfast and lunch)
Category
Treatment - Other

5

Description
Intervention group 5: Moderate-intensity aerobic training+resistance training+cinnamon group (In this group the Simultaneous intervention, moderate-intensity aerobic training+resistance training+cinnamon, will treat with the same protocol that describe at the previous part).
Category
Treatment - Other

6

Description
Intervention group 6: High-intensity aerobic training+resistance training+cinnamon group (In this group the Simultaneous intervention, high-intensity aerobic training+resistance training+cinnamon, will treat with the same protocol that describe at the previous part).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Noshahr Diabetes Association
Full name of responsible person
Ahmad Abdi
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
4616716187
Phone
+98 11 4321 7126
Fax
+98 11 4321 7009
Email
a.abdi58@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
AsiehAbbassi Daloii
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
4616716187
Phone
+98 11 4321 7126
Email
abbasi.daloii@gmail.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
Ahmad Abdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
461671618
Phone
+98 11 4321 7126
Email
A.abdi@iauamol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Barari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
4616716187
Phone
+98 11 4321 7126
Email
Alireza54.barari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Abdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
4616716187
Phone
+98 11 4321 7126
Email
A.abdi@iauamol.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The report is submitted to the research department of the university. Also published as a paper.
When the data will become available and for how long
Since 2025
To whom data/document is available
All researchers
Under which criteria data/document could be used
Citing references
From where data/document is obtainable
Scientific bases and Ayatollah Amoli Branch, Islamic Azad University, amol, Iran
What processes are involved for a request to access data/document
Maximum one week
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