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General information
2018-04-05, 1397/01/16
2018-04-19, 1397/01/30
2018-04-0519 00:00:00
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Protocol summary
Study aim
The effect of eight wks Yoga training on serum levels of Vaspin, insulin resistance and blood glucose in pregnant women with Gestational diabetes mellitus
Design
All mothers with gestational diabetes who are referred to the Prenatal Clinic of Hafez Hospital, affiliated to Shiraz University of Medical Sciences, are selected to receive health care. Sampling will be carried out voluntarily and out of available individuals. A sample of 30 non pregnant women with gestational age of 24 weeks and gestational diabetes mellitus (GDM), one hour glucose monitoring (OGTT) test, with 50 grams of glucose, was used to diagnose gestational diabetes.
Settings and conduct
The experimental group performed yoga exercises for eight weeks and five sessions per week, with three sessions a week with a mentor in the gymnasium of Hafez clinic and two sessions per week at home. Practice protocol includes Yoga Asana and Yoga Pranayama.
Participants/Inclusion and exclusion criteria
inclusion criteria:
All pregnant women with gestational diabetes and gestational age between 24 -30 wks have fasting blood glucose less than 105 mg / L and blood glucose less than 120 mg / dL.
Exclusion criteria:
pregnant women with cardiovascular disease, kidney and liver problems, pulmonary disease, or orthopedic restrictions and preeclampsia
Intervention groups
In this study, intervention group will perform the yoga practice for eight weeks and five sessions per week for one hour. The exercise protocol includes 21 moves from Asana and Pranayama Yoga. The experimental group will also receive standard diabetes care.
The control group will receive only standard diabetes care during these eight weeks and will not do yoga exercises.
Main outcome variables
The percentage of pregnant women with fasting blood glucose is less than 105 mg / L and blood glucose is below 120 mg / dL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140317017035N4
Registration date:2018-04-18, 1397/01/29
Registration timing:prospective
Last update:2019-09-15, 1398/06/24
Update count:1
Registration date
2018-04-18, 1397/01/29
Registrant information
Name
Maryam Kasraeian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 32365
Email address
kasraeem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-06-06, 1397/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 wks Yoga training on serum levels of Vaspin, insulin resistance and blood glucose in pregnant women with Gestational diabetes mellitus
Public title
Effect of Yoga training in Gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with Gestational diabetes mellitus
Gestational age between 24 -30 weeks
Fasting blood glucose less than 105 mg / L and blood glucose less than 120 mg / dL.
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
14336IR.SUMS.REC.139
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.SUMS.REC.1396.164
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
The percentage of pregnant women with fasting blood glucose is less than 105 mg / L and blood glucose is below 120.
Timepoint
The subjects' blood sugar levels will be measured 24 hours before the training protocol and 48 hours after the end of the protocol.
Method of measurement
Measurement of serum glucose by glucose oxidase (Pars Test, Iran)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention group will perform the yoga practice for 8 weeks and five sessions per week for one hour. The exercise protocol includes 21 moves from Asana and Pranayama Yoga. The experimental group will also receive standard diabetes care.
Category
Treatment - Other
2
Description
Control group: The control group will receive only standard diabetes care during these eight weeks and will not do yoga exercises.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Sarikhani
Street address
Shahid Chamran blvd, Hafez Clinic
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
fatimasarikhani38@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiraz University Of medical Science
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3230 5410
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Sarikhani
Position
MSC of Physilology exercise
Latest degree
Master
Other areas of specialty/work
Others
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
fatimasarikhani38@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
maryamkasraeian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Bazrafshan
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Human Ecology
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
bazrafshan.kh@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2018 Ethic form: 2018
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document