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Effect of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes

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History
# Registration date Revision Id
2 2019-09-19, 1398/06/28 104342
1 2014-12-19, 1393/09/28 6061
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of soy-protein consumption 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: 60 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 soy-protein (intervention group: n=30) or the standard diet (control group: n=30). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 5 months (September 5, 2014-Februray 4, 2015). 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 مصرف پروتئین سویا 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 آن هایی 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: 60 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 پروتئین سویا (گروه مداخله: 30=n) یا رژیم استاندارد (گروه کنترل30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو از بیماران گرفته خواهد شد. اگرچه مدت مداخله 6 هفته خواهد بود، ولی بیماران تا زمان زایمان پیگیری خواهند شد. زمان مداخله: 5 ماه (از 14 شهریور 1393 تا 15 بهمن 1393). 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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    The aim of this study is to determine the effects of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes.
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    هدف این مطالعه تعیین اثرات مصرف پروتئین سویا بر روی مقاومت به انسولین، فاکتور التهابی، بیومارکرهای استرس اکسیداتیو و نتایج بارداری در دیابت بارداری است.
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    Study design: Randomized controlled clinical trial.
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    طراحی مطالعه: تصادفي کارآزمایی بالینی.
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    Population and sample size: 68 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.
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    حجم نمونه و جمعیت مورد مطالعه: 68 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.
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    Inclusion criteria: Pregnant women with GDM at 24-28 weeks' gestation and aged 18 to 40 years will be included in this study. Exclusion criteria: History of diabetes, renal impairment, chronic hypertension, hypothyroidism, eclampsia, patients with preeclampsia, intra uterine fetal death (IUFD), placenta abruption and preterm delivery and FPG more than 105 and blood glucose 2-hour postprandial more than 120 mg/dL.
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    معیار ورود به مطالعه: زنان باردار مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: سابقه دیابت، اختلال کلیوی فشارخون مزمن، کم کاری تیروئید، اکلامسی، افراد مبتلا به پری اکلامسی، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس و FPG بیش از 105 و قند خون 2 ساعت بعد از مصرف بیش از 120 میلی گرم در دسی لیتر
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    Intervention: Patients will be assigned to receive either soy-protein (intervention group: n=34) or the standard diet (control group: n=34).
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    مداخله مورد مطالعه: بیماران برای دریافت پروتئین سویا (گروه مداخله: 34=n) یا رژیم استاندارد (گروه کنترل: 34=n) تقسیم خواهند شد.
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    Insulin and insulin resistance (primary outcome) and lipid, inflammatory factors and biomarkers of oxidative stress
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    انسولین و مقاومت به انسولین (پیامد اولیه) و فاکتورهای لیپیدی، التهابی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه)

  • General information

    Effect of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of
    Single blinded
    Not blinded
    60
    68
    2014-08-23, 1393/06/01
    2014-09-06, 1393/06/15
    2014-09-05, 1393/06/14
    2014-10-03, 1393/07/11
    Pregnant women aged 18-40 years
    Diagnosed with GDM at 24-28 weeks' gestation.
    زنان باردار 18-40 سال
    مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
    History of diabetes
    Renal impairment
    Chronic hypertension
    Hypothyroidism
    Eclampsia
    Patients with preeclampsia
    Intra uterine fetal death (IUFD), placenta abruption and preterm delivery.
    FPG more than 105 and blood glucose 2-hour postprandial more than 120 mg/dL
    سابقه دیابت
    اختلال کلیوی
    فشارخون مزمن
    کم کاری تیروئید
    اکلامسی
    افراد مبتلا به پری اکلامسی
    مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس
    FPG بیش از 105 و قند خون 2 ساعت بعد از مصرف بیش از 120 میلی گرم در دسی لیتر
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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 either soy-protein supplements (n=34) or the standard diet (n=34).
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و هفته های حاملگی، افراد به طور تصادفی به دو گروه برای دریافت پروتئین سویا (n=34) و رژیم استاندارد (n=34) تخصیص داده می شوند.
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  • Primary outcomes

    #1
    Fasting plasma glucose
    Insulin
    قند خون ناشتا
    انسولین
    Enzymatic
    Elisa kit
    آنزیمی
    کیت الایزا
    #2
    Triglycerides
    Insulin resistance
    تری گلیسرید
    مقاومت به انسولین
    Enzymatic
    Calculation using HOMA formula
    آنزیمی
    محاسبه با استفاده از فرمول HOMA
    #3
    Cholesterol
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    کلسترول
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #4
    Total antioxidant capacity
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    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #5
    Glutathione
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    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #6
    Malondialdehyde
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    مالون دی آلدئید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #7
    Hs-CRP
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    پروتئین واکنشگر C با حساسیت بالا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
    empty
    الایزا
    empty

  • Secondary outcomes

    #1
    empty
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #2
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #3
    empty
    Cholesterol
    empty
    کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #4
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #5
    empty
    Malondialdehyde
    empty
    مالون دی آلدئید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #6
    empty
    Hs-CRP
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
    empty
    الایزا
    #7
    empty
    HDL
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    HDL
    empty
    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #8
    empty
    LDL cholesterol
    empty
    LDL-کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #9
    empty
    Nitric Oxide
    empty
    نیتریک اکساید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #10
    empty
    Newborn's weight
    empty
    وزن نوزادان
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Scale
    empty
    ترازو
    #11
    empty
    Newborn's head circumference
    empty
    دور سر نوزادان
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Tape
    empty
    متر نواری
    #12
    empty
    Polyhydramnios
    empty
    پلی هیدروآمونیوس
    empty
    End-of-trial
    empty
    انتهای مداخله
    empty
    Sonographic
    empty
    سونوگرافی
    #13
    empty
    Newborn's length
    empty
    قد نوزادان
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Tape
    empty
    متر نواری
    #14
    empty
    Newborn's bilirubin
    empty
    بیلی روبین نوزادان تازه متولد شده
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #15
    empty
    Apgar score
    empty
    عدد آپگار
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Clinical observation
    empty
    مشاهده بالینی
    #16
    empty
    Newborns' hypoglycemia
    empty
    هیپوگلیسمی نوزادان تازه متولد شده
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #17
    empty
    Preterm delivery
    empty
    زایمان زودرس
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #18
    empty
    Maternal pre-eclampsia
    empty
    پری اکلامپسی مادران باردار
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #19
    empty
    Maternal hospitalization
    empty
    بستری شدن مادران
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #20
    empty
    Newborns' hospitalization
    empty
    بستری شدن نوزادان تازه متولد شده
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English:
    Street address - Persian:
    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: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    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 5562 0608
    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: Bolvare Ghotbe Ravandi, 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: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Bolvare Ghotbe Ravandi, 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 5554 2999
    Fax:
    Email: research@kaums.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:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Nutritionist
    Position - Persian: متخصص 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 5562 0608
    Mobile: +98 913 361 5446
    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: دکتری تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    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: +98
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.irasemi_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: Nutrition PhD
    Position - Persian: دکتری تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    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_z@kaums.ac
    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:
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    Street address - Persian:
    City - English: Kashan
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: +98
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.irasemi_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: Nutritionist
    Position - Persian: متخصص 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_z@kaums.ac
    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
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
The aim of this study is to determine the effects of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes.
Design
Study design: Randomized controlled clinical trial.
Settings and conduct
Population and sample size: 68 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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with GDM at 24-28 weeks' gestation and aged 18 to 40 years will be included in this study. Exclusion criteria: History of diabetes, renal impairment, chronic hypertension, hypothyroidism, eclampsia, patients with preeclampsia, intra uterine fetal death (IUFD), placenta abruption and preterm delivery and FPG more than 105 and blood glucose 2-hour postprandial more than 120 mg/dL.
Intervention groups
Intervention: Patients will be assigned to receive either soy-protein (intervention group: n=34) or the standard diet (control group: n=34).
Main outcome variables
Insulin and insulin resistance (primary outcome) and lipid, inflammatory factors and biomarkers of oxidative stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201412085623N31
Registration date: 2014-12-19, 1393/09/28
Registration timing: retrospective

Last update: 2019-09-21, 1398/06/30
Update count: 1
Registration date
2014-12-19, 1393/09/28
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
2014-09-06, 1393/06/15
Expected recruitment end date
2014-10-03, 1393/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and 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:
History of diabetes Renal impairment Chronic hypertension Hypothyroidism Eclampsia Patients with preeclampsia Intra uterine fetal death (IUFD), placenta abruption and preterm delivery. FPG more than 105 and blood glucose 2-hour postprandial more than 120 mg/dL
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: 68
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 either soy-protein supplements (n=34) or the standard diet (n=34).
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
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2014-09-05, 1393/06/14
Ethics committee reference number
29/5/1/4229/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
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa kit

2

Description
Insulin resistance
Timepoint
Baseline and End-of-trial
Method of measurement
Calculation using HOMA formula

Secondary outcomes

1

Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

2

Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

3

Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

4

Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

5

Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

6

Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa

7

Description
HDL
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

8

Description
LDL cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

9

Description
Nitric Oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

10

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

11

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

12

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

13

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

14

Description
Newborn's bilirubin
Timepoint
Delivery time
Method of measurement
Enzymatic kit

15

Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation

16

Description
Newborns' hypoglycemia
Timepoint
After delivery
Method of measurement
Enzymatic kit

17

Description
Preterm delivery
Timepoint
After delivery
Method of measurement
Medical record

18

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

19

Description
Maternal hospitalization
Timepoint
After delivery
Method of measurement
Medical record

20

Description
Newborns' hospitalization
Timepoint
After delivery
Method of measurement
Medical record

Intervention groups

1

Description
Intervention group: Soy-protein diet, 0.8 g/kg protein (35% animal protein, 35% soy protein, and 30% other vegetable proteins), daily for 6 weeks
Category
Treatment - Drugs

2

Description
Control group: Standard diet, 0.8 g/kg protein (70% animal and 30% vegetable proteins), daily for 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
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
Nutritionist
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 5562 0608
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
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac
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
Nutritionist
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_z@kaums.ac
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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