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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Protocol summary
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
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 .
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. ExclusionNon inclusion criteria: Unwillingness to cooperateThyroid 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 .
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاری.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: اختلالات تیروئید، سیگاری ها، پری اکلامپسی، اکلامپسی، آنهایی که مبتلا به بیماری های کبدی و کلیه بودند، نیاز به شروع انسولین درمانی در طول مداخله، گرفتن مکمل سلنیوم یا سایر آنتی اکسیدانت ها سه ماه قبل مداخله.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایلاختلالات تیروئید، سیگاری ها، پری اکلامپسی، اکلامپسی، آنهایی که مبتلا به همکاریبیماری های کبدی و کلیه بودند، نیاز به شروع انسولین درمانی در طول مداخله، گرفتن مکمل سلنیوم یا سایر آنتی اکسیدانت ها سه ماه قبل مداخله.
General information
Exclusion criteria: Unwillingness to cooperate.
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
Exclusion criteria: Unwillingness to cooperate.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
معیار خروج از مطالعه: عدم تمایل به همکاری.
اختلالات تیروئید
سیگاری ها
پری اکلامپسی
اکلامپسی
بیماری های کلیه و کبد
نیاز به شروع درمان انسولین در طول مداخله
گرفتن مکمل سلنیوم و سایر آنتی اکسیدانت ها سه ماه قبل مداخله
معیار خروج از مطالعه: عدم تمایلاختلالات تیروئید سیگاری ها پری اکلامپسی اکلامپسی بیماری های کلیه و کبد نیاز به همکاری.شروع درمان انسولین در طول مداخله گرفتن مکمل سلنیوم و سایر آنتی اکسیدانت ها سه ماه قبل مداخله
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
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.
At study baseline and, after stratification for pre-intervention BMI and agebalanced randomisation, subjects will be randomly dividedallocated into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه، بعد از تصادفی بالانس شده، افراد برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و، بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سنتصادفی بالانس شده، افراد به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
Protocol summary
Study aim
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
Design
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).
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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 .
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
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
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-16, 1397/02/26
Expected recruitment end date
2018-06-16, 1397/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of selenium supplementation in treatment of gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411290008
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Expressed levels of GLUT-1 gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of Lp(a) gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
3
Description
Expressed levels of LDL-R gene
Timepoint
At the beginning of the study and after 6 weeks of intervention