Protocol summary
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Study aim
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The effect of eight wks Yoga training on serum levels of Vaspin, insulin resistance and blood glucose in pregnant women with Gestational diabetes mellitus
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-04-18, 1397/01/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-19, 1397/01/30
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Expected recruitment end date
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2018-06-06, 1397/03/16
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of 8 wks Yoga training on serum levels of Vaspin, insulin resistance and blood glucose in pregnant women with Gestational diabetes mellitus
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Public title
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Effect of Yoga training in Gestational diabetes mellitus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-15, 1396/10/25
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Ethics committee reference number
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IR.SUMS.REC.1396.164
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes mellitus
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ICD-10 code
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O24.4
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ICD-10 code description
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Gestational diabetes mellitus
Primary outcomes
1
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Description
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The percentage of pregnant women with fasting blood glucose is less than 105 mg / L and blood glucose is below 120.
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Timepoint
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The subjects' blood sugar levels will be measured 24 hours before the training protocol and 48 hours after the end of the protocol.
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Method of measurement
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Measurement of serum glucose by glucose oxidase (Pars Test, Iran)
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: The control group will receive only standard diabetes care during these eight weeks and will not do yoga exercises.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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IPD: 2018 Ethic form: 2018
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To whom data/document is available
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IPD: Researcher & Patient Ethic form: Patient
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Under which criteria data/document could be used
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IPD: Ethic form: Awareness of test results
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From where data/document is obtainable
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IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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IPD: Vice chancellery Ethic form: Vice chancellery
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Comments
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