evaluate the effect of aerobic training with Spirulina supplementation on resistin and CRP in women with type 2 diabetes
Design
Exercise and Supplement, Exercise, Supplement, control a clinical trial with a control group, with parallel groups, randomized. The sample size is 10 people in each group.
Settings and conduct
The statistical population of this study is women with type 2 diabetes mellitus in Qom city. 60 of these people are selected based on inclusion and exclusion criteria the research. After completion of the consent form, the anthropometric and blood glucose characteristics of the subjects were recorded and based on the blood glucose of the subjects, the subjects were divided into four groups: 1_ aerobic + spirulina (15), 2_ aerobic (15 subjects), 3_ supplements (15 people), 4_ controls (15 people). Blood sampling is performed in two steps, one day before the training sessions and 48 hours after the end of the training. Spirulina supplementation is 2 grams per day for supplemental groups. Research variables will be measured after 6 weeks of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No Appearance and clinical signs of cardiovascular disease
Intervention groups
1. Aerobic group : Three sessions per week for 6 weeks 2. Spirulina supplements: Take 2 grams of spirulina daily 3. Supplement and Exercise Group: Two grams of spirulina supplement per day and three sessions of exercise per week for 6 weeks 3. Control group: no exercise and supplement
Main outcome variables
serum levels of resistin and CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171008036653N2
Registration date:2020-01-03, 1398/10/13
Registration timing:retrospective
Last update:2020-01-03, 1398/10/13
Update count:0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
mohsen akbarpour
Name of organization / entity
university of qom
Country
Iran (Islamic Republic of)
Phone
+98 25 3210 3690
Email address
m.akbarpoor@qom.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-11-22, 1398/09/01
Actual recruitment end date
2019-12-22, 1398/10/01
Trial completion date
2020-01-21, 1398/11/01
Scientific title
The effect of aerobic training and spirulina supplementation on resistin and CRP in women with type 2 diabetes
Public title
The effect of exercise training and spirulina supplementation on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No clinical signs of cardiovascular disease
T2D detection < 10 years ago Ages 40 to 50years old
No dependency to insulin
The use of commonly used diabetes medications, such as metformin and glenalbelamine
Exclusion criteria:
Cardiovascular disease
Coronary artery disease
Atrial fibrillation
High blood pressure
Congenital heart disease Retinopathy Neuropathy
Body mass index 25-30
Ischemia in echocardiography
Disability that causes difficulty in practice
Age
From 40 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, a simple randomization method will be used. The participants will be divided into 4 groups of 15 people. For this purpose, It is written from 1 to 4 numbers, ( There are 15 Repeat from each number) on the paper. Participants are asked that Each person take a number. so They will be grouped based on the number they picked.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Qom
Street address
street alghadir,University of Qom
City
Qom
Province
Ghoum
Postal code
3716146611
Approval date
2019-08-31, 1398/06/09
Ethics committee reference number
IR.QOM.REC.1398.007
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
Serum Resistin in women with type 2 diabetes
Timepoint
One day before the session begins and 48 hours after the end of the exercise
Method of measurement
The serum level of resistin will be measured by ELISA and using a commercial kit under the manufacturer's protocols (ZellBio GmbH, Germany).
2
Description
Serum CRP in women with type 2 diabetes
Timepoint
One day before the session begins and 48 hours after the end of the exercise
Method of measurement
The serum level of CRP will be measured by ELISA and using a commercial kit under the manufacturer's protocols .
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: The training group consisted of three sessions per week of aerobic training for 6 weeks. Training sessions consisted of 45 minutes walk or running on a treadmill. Each session is divided into 10 minutes of warming up , 10 minutes of cooling down with and 25 minutes of aerobic training (with an intensity of 65to 75% HRR).
Category
Other
2
Description
Group 2: Spirulina 2 grams daily, including 4 pills 500 mg before meals, for 6 weeks. This supplement is made by Qeshm algae and contains spirulina pure green algae. spirulina is a blue-green wonder aglae.
Category
Other
3
Description
Third intervention group: Exercise + supplement group consisting of three sessions per week of aerobic training for 6weeks and 2 grams of supplementation of spirulina per day for 6 weeks
Category
Other
4
Description
fourth intervention group: control group, No Spirulina supplement and no exercise
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Diabetes Association
Full name of responsible person
Qom Diabetes Association
Street address
Street Enghelab
City
Qom
Province
Ghoum
Postal code
371586791
Phone
+98 25 3210 3667
Email
ss.kk1159@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Qom
Full name of responsible person
Yaghob Norozi
Street address
Street Alghadir,University of Qom
City
Qom
Province
Ghoum
Postal code
3716146611
Phone
+98 25 3210 3690
Email
f.fathollahi1363@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Qom
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
The University of Qom
Full name of responsible person
Mohsen Akbarpour
Position
Association Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Street Alghadir,University of Qom
City
Qom
Province
Ghoum
Postal code
3716146611
Phone
+98 25 3210 3667
Email
akbarpour.mohsen@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Qom
Full name of responsible person
Mohsen Akbarpour
Position
Association Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Street Alghadir,University of Qom
City
Qom
Province
Ghoum
Postal code
3716146611
Phone
+98 25 3210 3667
Email
akbarpour.mohsen@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Qom
Full name of responsible person
Mohsen Akbarpour
Position
Association Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Street Alghadir,University of Qom
City
Qom
Province
Ghoum
Postal code
3716146611
Phone
+98 25 3210 3667
Email
akbarpour.mohsen@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The informed consent form will be available to others without mentioning the names of the participants. Details of the study process are also provided in detail in the file format.
When the data will become available and for how long
Start of the 6 month period after the research
To whom data/document is available
For university students and students in research related fields
Under which criteria data/document could be used
There are no specific conditions to provide such information.
From where data/document is obtainable
Mohsen akbarpour
What processes are involved for a request to access data/document
Send message to the person responsible for providing the data