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Effects of the Dietary Approaches to Stop Hypertension (DASH) on pregnancy outcomes in gestational diabetes

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History
# Registration date Revision Id
2 2019-09-23, 1398/07/01 105121
1 2013-02-18, 1391/11/30 6034
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes. Study design: parallel single-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with preeclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 40 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either the DASH diet (intervention group) or the standard diet (control group). Fasting blood samples will be taken at baseline and after 4-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Although the intervention will be done for 4 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 5 months (January 10, 2013-June 10, 2013). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH). Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
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    هدف: هدف این مطالعه تعیین اثرات راهکارهای رژیمی متوقف کننده فشار خون (DASH) بر روی مقاومت به انسولین، فاکتور التهابی، بیومارکرهای استرس اکسیداتیو و نتایج بارداری در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی یک سوکور موازی. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد خواهند شد. استفاده از درمان های جایگزین از قبیل هورمون یا مکمل ویتامینی و همچنین آنهایی که مبتلا به پری اکلامسی، استراحت مطلق، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس می شوند از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 40 زن باردار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت رژیم دش (گروه مداخله) یا رژیم استاندارد (گروه کنترل) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 4 هفته بعد از مداخله برای تعیین پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو از بیماران گرفته خواهد شد. اگرچه مدت مداخله 4 هفته خواهد بود، ولی بیماران تا زمان زایمان پیگیری خواهند شد. زمان مداخله: 5 ماه (از 21 دی 1391 تا 21 خرداد 1392). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، hs-CRP، ظرفیت آنتی اکسیدانی توتال و گلوتاتیون توتال پلاسما در ابتدا و انتهای مداخله اندازه گیری خواهد شد. وزن، قد، دور سر، عدد آپگار در 5 دقیقه و شاخص پوندرال نوزادان در زمان تولد، اندازه گیری خواهد شد.
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    Objective: The aim of this study is to determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on pregnancy outcomes in gestational diabetes.
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    هدف: هدف این مطالعه تعیین اثرات راهکارهای رژیمی متوقف کننده فشار خون (DASH) بر روی پیامدهای بارداری در دیابت بارداری است.
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    Study design: Parallel clinical trial. Randomization will be done by the use of computer-generated random numbers.
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    طراحي انجام مطالعه: کارآزمایی بالینی موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Population and sample size: Among patients with gestational diabetes referred to maternity Clinic affiliated to Kashan University of Medical Sciences, 58 patients will be selected according to inclusion and exclusion criteria.
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    حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک های مادران وابسته به دانشگاه علوم پزشکی کاشان، 58 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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    Inclusion criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria: A previous glucose intolerance/GDM diagnosis, premature preterm rupture of membrane, placenta abruption, pre-eclampsia, requiring to commence insulin therapy during intervention, complete bed rest, hypothyroidism, urinary tract infection, smoking, kidney or liver diseases, taking estrogen therapy.
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    معیار ورود به مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد خواهند شد. معیار خروج از مطالعه: یک تشخیص قبلی عدم تحمل گلوکز/دیابت بارداری، پارگی زودرس غشاء، جدا شدن جفت، پری اکلامسی، نیاز به شروع انسولین تراپی در طی مداخله، استراحت مطلق، کم کاری تیروئید، عفونت مجرای ادراری، سیگار کشیدن، بیماری های کلیوی یا کبدی، گرفتن استروژن تراپی.
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    Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 4 weeks. Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 4 weeks.
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    گروه مداخله: رژیم دش، 6 واحد سبزی، 6 واحد میوه، غنی از فبیر و غلات، روزانه برای مدت 4 هفته. گروه کنترل: رژیم استاندارد، 4 واحد سبزی، 4 واحد میوه، پروتئین زیاد، روزانه برای مدت 4 هفته.
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    Outcomes: Newborns' weight (primary outcomes) and other pregnancy outcomes (secondary outcome) will be quantified at study baseline and end-of-trial.
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    پيامدها: وزن تولد نوزادان تازه متولد شده (پیامدهای اولیه) و سایر پیامد بارداری (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    Single blinded
    Not blinded
    40
    58
    2013-01-10, 1391/10/21
    2013-02-12, 1391/11/24
    2013-06-11, 1392/03/21
    2013-03-12, 1391/12/22
    Effects of the Dietary Approaches to Stop Hypertension (DASH) on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes
    Effects of the Dietary Approaches to Stop Hypertension (DASH) on pregnancy outcomes in gestational diabetes
    اثرات رژیمی متوقف کننده فشار خون (DASH) بر روی مقاومت به انسولین، فاکتور التهابی، بیومارکرهای استرس اکسیداتیو و نتایج بارداری در دیابت بارداری
    اثرات رژیمی متوقف کننده فشار خون (DASH) بر روی پیامدهای بارداری در دیابت بارداری
    Pregnant women aged 18-40 years
    Diagnosed with GDM at 24-28 weeks' gestation
    زنان باردار 40-18 ساله
    مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
    A previous glucose intolerance/GDM diagnosis
    Premature preterm rupture of membrane
    Placenta abruption
    Pre-eclampsia
    Requiring to commence insulin therapy during intervention
    Complete bed rest
    Hypothyroidism
    Urinary tract infection
    Smoking
    Kidney or liver diseases
    Taking estrogen therapy
    یک تشخیص قبلی عدم تحمل گلوکز/دیابت بارداری
    پارگی زودرس غشاء
    جدا شدن جفت
    پری اکلامسی
    نیاز به شروع انسولین تراپی در طی مداخله
    استراحت مطلق
    کم کاری تیروئید
    عفونت مجرای ادراری
    سیگار کشیدن
    بیماری های کلیوی یا کبدی
    گرفتن استروژن تراپی
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    At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take DASH diet or the standard diet. Randomization will be done by the use of computer-generated random numbers.
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و هفته بارداری، افراد به طور تصادفی به دو گروه برای دریافت رژیم دش و رژیم استاندارد تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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  • Primary outcomes

    #1
    Serum insulin
    Newborns' weight
    انسولین سرم
    وزن نوزادان تازه متولد شده
    Baseline and End-of-trial
    The first 24 h after birth
    ابتدا و انتهای مداخله
    24 ساعت اول بعد از تولد
    Eliza
    Scale
    الایزا
    ترازو
    #2
    Serum hs-CRP
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    hs-CRP سرم
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Eliza
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    الایزا
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    #3
    Total antioxidant capacity
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    ظرفیت توتال آنتی اکسیدانی
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
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    #4
    Total glutathione
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    توتال گلوتاتیون
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    Baseline and End-of-trial
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    ابتدا و انتهای مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    empty
    #5
    Newborn's weight
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    وزن نوزادان
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    Birth time
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    زمان تولد
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    Scale
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    ترازو
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    #6
    Newborn's head circumference
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    محیط دورسر نوزادان
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    Birth time
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    زمان تولد
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    Measuring tape
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    نوار اندازه گیری
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    #7
    Newborn's height
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    قد نوزادان
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    Birth time
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    زمان تولد
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    Measuring tape
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    نوار اندازه گیری
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    #8
    Ponderal index
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    شاخص پوندرال
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    Birth time
    empty
    زمان تولد
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    Calculation
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    محاسبه
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    #9
    Polyhydramnios
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    پلی هیدروآمونیوس
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    30 weeks of pregnancy
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    هفته 30 بارداری
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    Sonography
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    سونوگرافی
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  • Secondary outcomes

    #1
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    Newborn length
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    قد نوزادان تازه متولد شده
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    The first 24 h after birth
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    24 ساعت اول بعد از تولد
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    Tape
    empty
    متر نواری
    #2
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    Newborn's head circumference
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    دور سر نوزادان
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    The first 24 h after birth
    empty
    24 ساعت اول بعد از تولد
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    Tape
    empty
    متر نواری
    #3
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    Polyhydramnios
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    پلی هیدروآمونیوس
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    After the intervention
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    بعد از مداخله
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    Sonography
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    سونوگرافی
    #4
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    Apgar score
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    عدد آپگار
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    Delivery time
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    زمان زایمان
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    Clinical observation
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    مشاهده بالینی

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic, Kashan
    Name of recruitment center - Persian: کلینیک نقوی، کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Maternity Clinic, Kashan
    Name of recruitment center - Persian: کلینیک زنان باردار، کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    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
    Street address - English: Ravandi ghotbe Avenue, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    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
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:
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    Public
    empty
    Domestic
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    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_r@yahoo.com
    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: Nutrition PhD
    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: Ravandi ghotbe Avenue, 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: 8719844189
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_za@yahoo.comasemi_z@kaums.ac.ir
    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: Nutrition PhD
    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: 8719844189
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_za@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: ذات اله عاصمی
    Position - English: PhD 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: Ravandi ghotbe avenue, 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: 8719844189
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_za@yahoo.comasemi_z@kaums.ac.ir
    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 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: 8719844189
    Phone: +98 36 1446 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_za@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
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    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 the Dietary Approaches to Stop Hypertension (DASH) diet on pregnancy outcomes in gestational diabetes.
Design
Study design: Parallel clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: Among patients with gestational diabetes referred to maternity Clinic affiliated to Kashan University of Medical Sciences, 58 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria: A previous glucose intolerance/GDM diagnosis, premature preterm rupture of membrane, placenta abruption, pre-eclampsia, requiring to commence insulin therapy during intervention, complete bed rest, hypothyroidism, urinary tract infection, smoking, kidney or liver diseases, taking estrogen therapy.
Intervention groups
Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 4 weeks. Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 4 weeks.
Main outcome variables
Outcomes: Newborns' weight (primary outcomes) and other pregnancy outcomes (secondary outcome) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201212195623N4
Registration date: 2013-02-18, 1391/11/30
Registration timing: registered_while_recruiting

Last update: 2019-09-25, 1398/07/03
Update count: 1
Registration date
2013-02-18, 1391/11/30
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
Kashan University of Medical Sciences
Expected recruitment start date
2013-02-12, 1391/11/24
Expected recruitment end date
2013-03-12, 1391/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of the Dietary Approaches to Stop Hypertension (DASH) on pregnancy outcomes in gestational diabetes
Public title
Effect of diet therapy in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-40 years Diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
A previous glucose intolerance/GDM diagnosis Premature preterm rupture of membrane Placenta abruption Pre-eclampsia Requiring to commence insulin therapy during intervention Complete bed rest Hypothyroidism Urinary tract infection Smoking Kidney or liver diseases Taking estrogen therapy
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: 58
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take DASH diet or the standard diet. Randomization will be done by the use of computer-generated random numbers.
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
Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2013-02-11, 1391/11/23
Ethics committee reference number
29/5/1/4139/پ

Health conditions studied

1

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

Primary outcomes

1

Description
Newborns' weight
Timepoint
The first 24 h after birth
Method of measurement
Scale

Secondary outcomes

1

Description
Newborn length
Timepoint
The first 24 h after birth
Method of measurement
Tape

2

Description
Newborn's head circumference
Timepoint
The first 24 h after birth
Method of measurement
Tape

3

Description
Polyhydramnios
Timepoint
After the intervention
Method of measurement
Sonography

4

Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation

Intervention groups

1

Description
Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 4 weeks
Category
Other

2

Description
Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 4 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternity Clinic, Kashan
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8719844189
Phone
+98 36 1446 3378
Fax
Email
asemi_za@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 Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8719844189
Phone
+98 36 1446 3378
Fax
Email
asemi_za@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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