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Clinical trial of the effect of fish oil supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with gestational diabetes

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History
# Registration date Revision Id
2 2019-09-23, 1398/07/01 105024
1 2016-10-11, 1395/07/20 6120
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 40 patients with gestational diabetes of eligible and referred to Kosar clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either fish oil (n=20) or placebo (n=20). Fish oil and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری روغن ماهی بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به دیابت بارداری است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 40 بیمار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل روغن ماهی (20=n) یا پلاسبو (20=n) تقسیم خواهند شد. کپسول های مکمل روغن ماهی و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته. پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with gestational diabetes.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری روغن ماهی بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به دیابت بارداری است.
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    Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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    طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Population and sample size: 40 patients with gestational diabetes of eligible and referred to Kosar gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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    حجم نمونه و جمعیت مورد مطالعه: 40 بیمار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک زنان کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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    Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria:Taking fish oil supplements, insulin therapy, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers.
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    معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: گرفتن مکمل روغن ماهی، انسولین تراپی، جدا شدن زودرس جفت، پری اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، سیگاری ها.
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    Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
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    گروه مداخله: 1000 میلی گرم روغن ماهی (باریج اسانس، کاشان، ایران)، دو بار در روز، به صورت خوراکی برای 6 هفته. گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، دو بار در روز، به صورت خوراکی برای 6 هفته.
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    Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
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    پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    1
    1
    1
    2016-07-25, 1395/05/04
    2016-07-26, 1395/05/05
    2016-08-08, 1395/05/18
    2016-08-10, 1395/05/20
    Patients with gestational diabetes
    Aged 18 to 40 years
    بیماران مبتلا به دیابت بارداری
    در محدوده سنی 18 تا 40 سال
    Taking fish oil supplements
    Insulin therapy
    Placenta abruption
    Pre-eclampsia
    Eclampsia
    Hypo and hyperthyroidism
    Smokers
    گرفتن مکمل روغن ماهی
    انسولین تراپی
    جدا شدن زودرس جفت
    پری اکلامپسی
    اکلامپسی
    کم کاری و پرکاری تیروئید
    سیگاری ها
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    Randomization will be done by the use of computer-generated random numbers.
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    تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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  • Primary outcomes

    #1
    GLUT-1
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    GLUT-1
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    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
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    PCR
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    PCR
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  • Secondary outcomes

    #1
    Interleukin 6
    Gene expression of interleukin 1
    اینترلوکین 6
    بیان ژن اینترلوکین 1
    #2
    Tumor necrosis factor alpha
    Gene expression of tumor necrosis factor alpha
    فاکتور نکروز آلفا
    بیان ژن فاکتور نکروز آلفا
    #3
    empty
    Gene expression of interleukin 8
    empty
    بیان ژن اینترلوکین 8
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    PCR
    empty
    PCR
    #4
    empty
    Gene expression of LDLR
    empty
    بیان ژن LDLR
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    PCR
    empty
    PCR
    #5
    empty
    Fasting plasma glucose
    empty
    گلوکز پلاسمایی ناشتا
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    Insulin
    empty
    انسولین
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    ELISA kit
    empty
    کیت الایزا
    #7
    empty
    Insulin resistance
    empty
    مقاومت به انسولین
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    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Calculation using HOMA formula
    empty
    محاسبه با استفاده از فرمول HOMA
    #8
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #9
    empty
    Total cholesterol
    empty
    توتال کلسترول
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #10
    empty
    HDL
    empty
    HDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #11
    empty
    High-sensitivity C-reactive protein
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    ELISA kit
    empty
    کیت الایزا
    #12
    empty
    Newborn's head circumference
    empty
    دور سر نوزادان
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    Delivery time
    empty
    زمان زایمان
    empty
    Tape
    empty
    متر نواری
    #13
    empty
    Polyhydramnios
    empty
    پلی هیدروآمونیوس
    empty
    End-of-trial
    empty
    انتهای مداخله
    empty
    Sonographic
    empty
    سونوگرافی
    #14
    empty
    Apgar score
    empty
    عدد آپگار
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Clinical observation
    empty
    مشاهده بالینی
    #15
    empty
    Preterm delivery
    empty
    زایمان زودرس
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #16
    empty
    Maternal pre-eclampsia
    empty
    پری اکلامپسی مادران باردار
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #17
    empty
    Newborn's length
    empty
    قد نوزادان
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Delivery time
    empty
    متر نواری
    #18
    empty
    Newborn's weight
    empty
    وزن نوزادان
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Scale
    empty
    ترازو

  • Recruitment centers

    #1
    Name of recruitment center - English: Kosar clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English:
    Street address - Persian:
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Kosar gynecology clinic
    Name of recruitment center - Persian: کلینیک زنان کوثر
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English: Emam Khomeyni Avenue, Arak
    Street address - Persian: اراک، خیابان امام خمینی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3223 3823
    Fax:
    Email: jamilian.mehri@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mohammad Rafiee
    Full name of responsible person - Persian: محمد رفیعی
    Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
    Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mohammad Rafiee
    Full name of responsible person - Persian: محمد رفیعی
    Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
    Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3639
    Fax:
    Email: research@arakmu.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: 00
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذ ات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذ ات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Undecided - It is not yet known if there will be a plan to make this available.
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    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست.

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with gestational diabetes.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: 40 patients with gestational diabetes of eligible and referred to Kosar gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria:Taking fish oil supplements, insulin therapy, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers.
Intervention groups
Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
Main outcome variables
Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201610015623N90
Registration date: 2016-10-11, 1395/07/20
Registration timing: retrospective

Last update: 2019-09-25, 1398/07/03
Update count: 1
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-07-26, 1395/05/05
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of fish oil supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with gestational diabetes
Public title
Effect of supplementation in treatment of women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gestational diabetes Aged 18 to 40 years
Exclusion criteria:
Taking fish oil supplements Insulin therapy Placenta abruption Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
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 Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.ARAKMU.REC.1395.160

Health conditions studied

1

Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
PPAR-γ
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

Secondary outcomes

1

Description
Gene expression of interleukin 1
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

2

Description
Gene expression of tumor necrosis factor alpha
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

3

Description
Gene expression of interleukin 8
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

4

Description
Gene expression of LDLR
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

5

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
ELISA kit

7

Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation using HOMA formula

8

Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

9

Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

10

Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

11

Description
High-sensitivity C-reactive protein
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
ELISA kit

12

Description
Newborn's head circumference
Timepoint
Delivery time
Method of measurement
Tape

13

Description
Polyhydramnios
Timepoint
End-of-trial
Method of measurement
Sonographic

14

Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation

15

Description
Preterm delivery
Timepoint
After delivery
Method of measurement
Medical record

16

Description
Maternal pre-eclampsia
Timepoint
After delivery
Method of measurement
Medical record

17

Description
Newborn's length
Timepoint
Delivery time
Method of measurement
Delivery time

18

Description
Newborn's weight
Timepoint
Delivery time
Method of measurement
Scale

Intervention groups

1

Description
Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar gynecology clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3223 3823
Email
jamilian.mehri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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