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Protocol summary
Objective: The aim of this study is to determine the effects of magnesium and omega-3 supplementation on insulin resistance and inflammatory factor in gestational diabetes. Study design: Double-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 pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 120 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 magnesium supplement (n=30), omega-3 supplement (n=30), placebo for magnesium (n=30) and placebo for omega-3 (n=30). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles and inflammatory factor. Start and End Date of Intervention: 2 months (December 24, 2013- February 24, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin and hs-CRP levels.
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Objective: The aim of this study is to determine the effects of magnesium and omega-3 supplementation on insulin resistance and inflammatory factor in gestational diabetes. Study design: Double-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 pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 120 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 magnesium supplement (n=30), omega-3 supplement (n=30), placebo for magnesium (n=30) and placebo for omega-3 (n=30). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles and inflammatory factor. Start and End Date of Intervention: 2 months (December 24, 2013- February 24, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin and hs-CRP levels.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم و امگا 3 بر روی مقاومت به انسولین و فاکتور التهابی در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور. 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: 120 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 مکمل منیزیم (30n=)، مکمل امگا 3 (30n=)، پلاسبو برای منیزیم (30n=) و پلاسبو برای امگا 3 (30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین پروفایل های متابولیک و فاکتور التهابی از بیماران گرفته خواهد شد. زمان مداخله: 2 ماه (از 3 دی 1392 تا 3 اسفند 1392). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین و hs-CRP در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم و امگا 3 بر روی مقاومت به انسولین و فاکتور التهابی در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور. 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: 120 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 مکمل منیزیم (30n=)، مکمل امگا 3 (30n=)، پلاسبو برای منیزیم (30n=) و پلاسبو برای امگا 3 (30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین پروفایل های متابولیک و فاکتور التهابی از بیماران گرفته خواهد شد. زمان مداخله: 2 ماه (از 3 دی 1392 تا 3 اسفند 1392). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین و hs-CRP در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of omega-3 supplementation on insulin resistance and lipid profiles in gestational diabetes.
The aim of this study is to determine the effects of omega-3 supplementation on insulin resistance and lipid profiles in gestational diabetes.
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هدف این مطالعه تعیین اثرات مکمل یاری امگا 3 بر روی مقاومت به انسولین و پروفایل های لیپیدی در دیابت بارداری است.
هدف این مطالعه تعیین اثرات مکمل یاری امگا 3 بر روی مقاومت به انسولین و پروفایل های لیپیدی در دیابت بارداری است.
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Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers.
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers.
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طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences and Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 56 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences and Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 56 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
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از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان و کوثر وابسته به دانشگاه علوم پزشکی اراک، 56 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل 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.
از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان و کوثر وابسته به دانشگاه علوم پزشکی اراک، 56 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل 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.
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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 pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study.
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 pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study.
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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.
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.
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Intervention: Patients will be assigned to receive omega-3 supplement (n=28) and placebo (n=28).
Intervention: Patients will be assigned to receive omega-3 supplement (n=28) and placebo (n=28).
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مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا 3 (28n=) و پلاسبو (28n=) تقسیم خواهند شد.
مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا 3 (28n=) و پلاسبو (28n=) تقسیم خواهند شد.
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Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial
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پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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120
56
12056
2014-02-14, 1392/11/25
2014-03-03, 1392/12/12
2014-0203-1403 00:00:00
2014-04-15, 1393/01/26
2014-03-15, 1392/12/24
2014-0403-15 00:00:00
The effect of magnesium in the treatment of gestational diabetes
The effect of omega-3 in the treatment of gestational diabetes
The effect of magnesiumomega-3 in the treatment of gestational diabetes
اثر منیزیم در درمان دیابت بارداری
اثر امگا-3 در درمان دیابت بارداری
اثر منیزیمامگا-3 در درمان دیابت بارداری
The effect of magnesium supplementation on insulin resistance and inflammatory factors in women with gestational diabetes
The effect of omega-3 supplementation on insulin resistance and lipid profiles in women with gestational diabetes
The effect of magnesiumomega-3 supplementation on insulin resistance and inflammatory factorslipid profiles in women with gestational diabetes
اثر مکمل یاری منیزیم بر روی مقاومت انسولین و فاکتور التهابی در زنان مبتلا به دیابت بارداری
اثر مکمل یاری امگا- 3 بر روی مقاومت انسولین و پروفایل های لیپیدی در زنان مبتلا به دیابت بارداری
اثر مکمل یاری منیزیمامگا- 3 بر روی مقاومت انسولین و فاکتور التهابیپروفایل های لیپیدی در زنان مبتلا به دیابت بارداری
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 weeks' gestation
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
زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
The use of substitute treatments including hormone or vitamin supplements
Patients with pre-eclampsia
Complete bed rest (CBR)
Intra uterine fetal death (IUFD)
Placenta abruption
Preterm delivery
The use of substitute treatments including hormone or vitamin supplements Patients with pre-eclampsia Complete bed rest (CBR) Intra uterine fetal death (IUFD) Placenta abruption Preterm delivery
استفاده از درمان های جايگزين از قبیل هورمون یا مکمل ویتامینی
افراد مبتلا به پری اکلامسی
استراحت مطلق
مرگ جنینی داخل رحمی
جدا شدن جفت
زایمان زودرس
استفاده از درمان های جايگزين از قبیل هورمون یا مکمل ویتامینی افراد مبتلا به پری اکلامسی استراحت مطلق مرگ جنینی داخل رحمی جدا شدن جفت زایمان زودرس
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Patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
Patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
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بیماران به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
بیماران به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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.
شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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Primary outcomes
#1
Baseline and End-of-trial
At the beginning of the study and after 6 weeks of intervention
BaselineAt the beginning of the study and End-after 6 weeks of-trial intervention
ابتدا و انتهای مداخله
در ابتدای مطالعه و 6 هفته بعد از مداخله
ابتدادر ابتدای مطالعه و انتهای6 هفته بعد از مداخله
Elisa
Elisa kit
Elisa kit
#2
Hs-CRP
Insulin resistance
Hs-CRPInsulin resistance
پروتئین واکنشگر C با حساسیت بالا
مقاومت به انسولین
پروتئین واکنشگر C با حساسیت بالامقاومت به انسولین
Baseline and End-of-trial
At the beginning of the study and after 6 weeks of intervention
BaselineAt the beginning of the study and End-after 6 weeks of-trial intervention
ابتدا و انتهای مداخله
در ابتدای مطالعه و 6 هفته بعد از مداخله
ابتدادر ابتدای مطالعه و انتهای6 هفته بعد از مداخله
Elisa
Calculation using HOMA formula
ElisaCalculation using HOMA formula
الایزا
محاسبه با استفاده از فرمول HOMA
الایزامحاسبه با استفاده از فرمول HOMA
#3
Fasting plasma glucose
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Fasting plasma glucose
قند خون ناشتا
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قند خون ناشتا
Baseline and End-of-trial
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Baseline and End-of-trial
ابتدا و انتهای مداخله
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ابتدا و انتهای مداخله
Enzymatic
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Enzymatic
آنزیمی
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آنزیمی
#4
Triglycerides
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Triglycerides
تری گلیسرید
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تری گلیسرید
Baseline and End-of-trial
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Baseline and End-of-trial
ابتدا و انتهای مداخله
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ابتدا و انتهای مداخله
Enzymatic
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Enzymatic
آنزیمی
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آنزیمی
#5
Cholesterol
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Cholesterol
کلسترول
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کلسترول
Baseline and End-of-trial
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Baseline and End-of-trial
ابتدا و انتهای مداخله
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ابتدا و انتهای مداخله
Enzymatic
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Enzymatic
آنزیمی
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آنزیمی
Secondary outcomes
#1
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Total cholesterol
Total cholesterol
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توتال کلسترول
توتال کلسترول
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At the beginning of the study and after 6 weeks of intervention
At the beginning of the study and after 6 weeks of intervention
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در ابتدای مطالعه و 6 هفته بعد از مداخله
در ابتدای مطالعه و 6 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#2
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Triglycerides
Triglycerides
empty
تری گلیسرید
تری گلیسرید
empty
At the beginning of the study and after 6 weeks of intervention
At the beginning of the study and after 6 weeks of intervention
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در ابتدای مطالعه و 6 هفته بعد از مداخله
در ابتدای مطالعه و 6 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#3
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HDL-cholesterol
HDL-cholesterol
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کلسترول HDL
کلسترول HDL
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At the beginning of the study and after 6 weeks of intervention
At the beginning of the study and after 6 weeks of intervention
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در ابتدای مطالعه و 6 هفته بعد از مداخله
در ابتدای مطالعه و 6 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
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: 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: 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: 8115187159
Phone: +98 31 5545 1515
Fax:
Email: asemi_r@yahoo.com
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: 8115187159 Phone: +98 31 5545 1515 Fax: Email: asemi_r@yahoo.com Web page address:
#2
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: 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: 3814113634
Phone: +98 86 3223 3823
Fax:
Email: jamilian.mehri@gmail.com
Web page address:
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: 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: 3814113634 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: 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:
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
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: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: 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 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: 8115187159 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
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public
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domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
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Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
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Latest degree:
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contact.provinces_available:
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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: 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: Bolvare Ghotbe Ravandi, 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: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: 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: 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: Bolvare Ghotbe Ravandi, 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: 8115187159 Phone: +98 31 5546 3378 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: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bolvare Ghotbe Ravandi, 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 36 1446 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: 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: Bolvare Ghotbe Ravandi, 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: 8115187159
Phone: 0098 36 1446 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_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: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bolvare Ghotbe Ravandi, 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: 8115187159 Phone: +980098 36 1446 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.irasemi_r@yahoo.comkaums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
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: 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:
Street address - Persian:
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 00
Mobile: 00
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: 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: Bolvare Ghotbe Ravandi, 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: 8115187159
Phone: +98 31 5554 0021
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: 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: Nutrition PhD Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bolvare Ghotbe Ravandi, 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: 8115187159 Phone: 00+98 31 5554 0021 Mobile: 00+98 913 361 5446 Fax: Email: asemi_r@yahoo.com Web page address:
Sharing plan
undecided
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Undecided - It is not yet known if there will be a plan to make this available
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
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of omega-3 supplementation on insulin resistance and lipid profiles in gestational diabetes.
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences and Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 56 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Participants/Inclusion and exclusion criteria
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 pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study.
Intervention groups
Intervention: Patients will be assigned to receive omega-3 supplement (n=28) and placebo (n=28).
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201312265623N16
Registration date:2014-03-10, 1392/12/19
Registration timing:registered_while_recruiting
Last update:2019-08-11, 1398/05/20
Update count:1
Registration date
2014-03-10, 1392/12/19
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
2014-03-03, 1392/12/12
Expected recruitment end date
2014-03-15, 1392/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 supplementation on insulin resistance and lipid profiles in women with gestational diabetes
Public title
The effect of omega-3 in the 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:
The use of substitute treatments including hormone or vitamin supplements
Patients with pre-eclampsia
Complete bed rest (CBR)
Intra uterine fetal death (IUFD)
Placenta abruption
Preterm delivery
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:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
29/5/1/5007/P
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention