Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of selenium supplementation on gene expression related to insulin and lipid in patients with gestational diabetes mellitus
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Design
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Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive selenium supplement (n=20) or placebo (n=20).
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Settings and conduct
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Among patients with gestational diabetes referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Non inclusion criteria: Thyroid disorders, smokers, pre-eclampsia, eclampsia, those with kidney or liver diseases and required insulin therapy during intervention, taking selenium supplements or other antioxidants 3 months before the intervention .
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Intervention groups
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Intervention group: Selenium supplements (Nature, California, USA), 200 µg, daily, for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 6 weeks orally.
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Main outcome variables
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Outcomes: Expressed levels of PPAR-γ gene (primary outcome) and Expressed levels of GLUT-1, Lp(a) and LDL-R genes (secondary outcomes) will be quantified at study baseline and end-of-trial.
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:
IRCT20170513033941N35
Registration date:
2018-06-20, 1397/03/30
Registration timing:
retrospective
Last update:
2019-09-11, 1398/06/20
Update count:
1
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Registration date
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2018-06-20, 1397/03/30
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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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2018-05-16, 1397/02/26
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Expected recruitment end date
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2018-06-16, 1397/03/26
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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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Clinical trial of the effect of selenium supplementation compared with the placebo on gene expression related to insulin and lipid in women with gestational diabetes mellitus
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Public title
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Effect of selenium supplementation in treatment of 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:
Inclusion criteria: Patients with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Thyroid disorders
Smokers
Pre-eclampsia
Eclampsia
Kidney or liver diseases
Requiring insulin therapy during intervention
Taking selenium supplements or other antioxidants 3 months before the intervention
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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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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline, after balanced randomisation, subjects will be allocated into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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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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2018-05-15, 1397/02/25
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Ethics committee reference number
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IR.IUMS.FMD.REC.1396.9411290008
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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O24.9
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ICD-10 code description
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Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
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Description
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Expressed levels of PPAR-γ gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
Secondary outcomes
1
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Description
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Expressed levels of GLUT-1 gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Expressed levels of Lp(a) gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
3
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Description
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Expressed levels of LDL-R gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
Intervention groups
1
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Description
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Intervention group: Selenium supplements (Nature, California, USA), 200 µg, daily, for 6 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 6 weeks orally.
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Category
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Placebo
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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Iran 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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be 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