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The effect of 8 weeks of combined home-based exercise and Camelina oil consumption on insulin resistance, lipid profile, quality of life and some psychological indices in women with type 2 diabetes

Protocol summary

Study aim
Effect of eight weeks of combined home-based exercise and Camelina oil consumption on: insulin resistance fasting blood glucose lipid profile quality of life depression severity physical self-concept quality of sleep anxiety self-esteem in women with type 2 diabetes
Design
A clinical trial with a control group, parallel groups on 48 patients, permuted block randomization via www.randomization.com
Settings and conduct
This study is conducted at the Faculty of Sport Sciences of Razi University, Kermanshah, Iran. After the familiarization session, the study variables are measured, and then, 4 experimental groups perform their own relevant prescribed interventions for 8 weeks. Then, the variables are measured again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Not participation in regular exercise over the last 6 months Having type 2 diabetes confirmed by a specialist Fasting blood glucose of equal or more than 126 milligrams in deciliter to 400 milligrams in deciliter No insulin injection Getting the certification of no prohibition of participating in the exercise training from a specialist Exclusion Criteria: Acute or chronic inflammatory diseases Heart diseases Pregnancy Alcohol and other kinds of drug addiction Musculoskeletal disorder Refusal to give informed consent
Intervention groups
1) Exercise + Camelina: home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks and, daily consumption of 27 grams of Camelina oil with meals. 2) Exercise: home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks. 3) Camelina: daily consumption of 27 grams of Camelina oil with meals for 8 weeks. 4) Control:normal life during the project
Main outcome variables
Change in: insulin resistance fasting blood glucose lipid profile quality of life depression severity physical self-concept quality of sleep anxiety self-esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210617051606N2
Registration date: 2021-09-13, 1400/06/22
Registration timing: registered_while_recruiting

Last update: 2021-09-13, 1400/06/22
Update count: 0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Ehsan Amiri
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3845 8428
Email address
e.amiri@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of combined home-based exercise and Camelina oil consumption on insulin resistance, lipid profile, quality of life and some psychological indices in women with type 2 diabetes
Public title
The effect of exercise training and Camelina oil consumption on type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not participation in regular exercise training over the last 6 months Having type 2 diabetes confirmed by specialist Fasting blood glucose of equal or more than 126 milligrams in deciliter to 400 milligrams in deciliter No insulin injection Getting the certification of no prohibition of participating in exercise training program from a specialist
Exclusion criteria:
Acute or chronic inflammatory diseases Heart diseases Pregnancy Alcohol and other kinds of drug addiction Musculoskeletal disorder Refusal to give informed consent
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permuted block randomization via the www.randomization.com website will be used. To do so, first, a unique number will be allocated to each subject as the identifier code and, a 48-digit sequence (equal to sample size) will be created. Then, treatment labels including 1) exercise + Camelina group; 2) Exercise group; 3) Camelina group, and 4) control group will be entered in the relevant section on the website. After defining the treatment groups and to avoid potential problems associated with equal block sizes, permuted block randomization with differents block sizes will be applied. In this case, by knowing the sample size, the block sizes will be unequal and a multiple of the number of treatment groups (for example, block sizes of 2, 4, 6, or 8). The website has the ability to randomly specify the sequence of blocks with different sizes. In the final step and upon performing the 'Generate Plan' on the website, all subjects will be randomly assigned to blocks of different sizes that already have a random sequence. Finally, the group (treatment) of each subject will be specified by the use of the identifier code and checking out the blocks
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
Research Ethics Committees of Kermanshah Razi University
Street address
Deputy of Research and Technology, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.RAZI.REC.1400.042

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Changes in insulin resistance
Timepoint
Before starting the intervention, and 8 weeks after starting the intervention
Method of measurement
By blood sample and Hemostatic Model Assessment for Insulin Resistance (HOMA-IR). In this case, fasting blood insulin and glucose are measured and then, they will be put in the HOMA-IR formula.

2

Description
Changes in fasting blood glucose
Timepoint
Before starting the intervention, and 8 weeks after starting the intervention
Method of measurement
By blood sample in fasting condition

3

Description
Changes in lipid profile
Timepoint
Before starting the intervention, and 8 weeks after starting the intervention
Method of measurement
By blood sample in fasting condition

4

Description
Change in quality of life
Timepoint
Before starting the intervention, and 8 weeks after starting the intervention
Method of measurement
World health organization standard quality of life questionnaire (short version)

5

Description
Change in depression severity
Timepoint
Before starting the intervention, and 8 weeks after starting the intervention
Method of measurement
Hamilton Depression Rating Scale

Secondary outcomes

1

Description
Change in physical self-concept
Timepoint
Before intervention and after 8 weeks of intervention
Method of measurement
Physical self-concept questionnaire

2

Description
Change in the quality of sleep
Timepoint
Before intervention and after 8 weeks of intervention
Method of measurement
Pittsburgh Sleep Quality Index

3

Description
Change in anxiety
Timepoint
Before intervention and after 8 weeks of intervention
Method of measurement
Beck Anxiety Inventory

4

Description
Change in self-esteem
Timepoint
Before intervention and after 8 weeks of intervention
Method of measurement
Rosenberg’s Self-Esteem Scale

Intervention groups

1

Description
Intervention group (Exercise + Camelina): this group performs combined home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks. The intensity of aerobic and resistance training will be controlled by the use of a 6-20 Borg scale. In the first week, the training intensity will be 11 and, in week 8, the intensity will be 13 on the Borg scale. The aerobic training is in category A according to American College of Sports Medicine (ACSM) guidelines that require minimum skill and physical fitness. The resistance training includes Squat, Lunges, and Push-up by the use of body weight. This group also consumes 27 grams of Camelina oil per day with meals for 8 weeks. This oil is transparent yellow in color and has no unusual taste and smell. Camelina oil has a standard document proved by Iran National Standards Organization.
Category
Other

2

Description
Intervention group 2 (Exercise): this group performs combined home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks. The intensity of aerobic and resistance training will be controlled by the use of a 6-20 Borg scale. In the first week, the training intensity will be 11 and, in week 8, the intensity will be 13 on the Borg scale. The aerobic training is in category A according to American College of Sports Medicine (ACSM) guidelines that require minimum skill and physical fitness. The resistance training includes Squat, Lunges, and Push-up by the use of body weight.
Category
Other

3

Description
Intervention group 3 (Camelina): This group consumes 27 grams of Camelina oil per day with meals for 8 weeks. This oil is transparent yellow in color and has no unusual taste and smell. Camelina oil has a standard document proved by Iran National Standards Organization.
Category
Other

4

Description
Control group: this group has the the normal life during the study
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital of Kermanshah
Full name of responsible person
Mehr Ali Rahimi
Street address
Next to the Faculty of Medicine, Parastar Blv, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3836 2014
Email
mjavadra@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Dr. Farzad Veysi
Street address
University St, Taq-e-Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
veysi@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi 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
Razi University
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Fax
Email
e.amiri@razi.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Room 73. Faculty of Sport Sciences, Razi University, University St, Taq-e-Bostan, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7609
Email
e.amiri@razi.ac.ir
Web page address
https://phe.razi.ac.ir/~e.amiri

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Room 73. Faculty of Sport Sciences, Razi University, University St, Taq-e-Bostan, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7609
Email
e.amiri@razi.ac.ir
Web page address
https://phe.razi.ac.ir/~e.amiri

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data are shared after the de-identification of the participants
When the data will become available and for how long
3 months after publication
To whom data/document is available
All individuals upon formal request
Under which criteria data/document could be used
Data sharing requests are accepted for any purposes
From where data/document is obtainable
To obtain any data/document, please send an e-mail to Ehsan Amiri, a faculty member at Razi University, through the following e-mail address: e.amiri@razi.ac.ir
What processes are involved for a request to access data/document
Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail
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