Clinical trial of the effect of magnesium supplementation compared with the placebo on gene expression related to insulin and lipid in women with gestational diabetes
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Protocol summary
Objective: The aim of this study is to determine the effects of magnesium supplementation on gene expression related to insulin and lipid in patients of gestational diabetes. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive magnesium (n=20) or placebo (n=20). Magnesium and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Gene expression related to insulin (primary outcomes) and gene expression related to lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of magnesium supplementation on gene expression related to insulin and lipid in patients of gestational diabetes. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive magnesium (n=20) or placebo (n=20). Magnesium and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Gene expression related to insulin (primary outcomes) and gene expression related to lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر بیان ژن مرتبط با انسولین و چربی در بیماران مبتلا به دیابت بارداری است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 40 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت منیزیم (20=n) یا پلاسبو (20=n) اختصاص داده خواهند شد. کپسول های منیزیم و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته. پيامدها: بیان ژن مرتبط با انسولین (پیامدهای اولیه) و بیان ژن مرتبط با لیپید (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر بیان ژن مرتبط با انسولین و چربی در بیماران مبتلا به دیابت بارداری است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 40 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت منیزیم (20=n) یا پلاسبو (20=n) اختصاص داده خواهند شد. کپسول های منیزیم و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته. پيامدها: بیان ژن مرتبط با انسولین (پیامدهای اولیه) و بیان ژن مرتبط با لیپید (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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Objective: The aim of this study is to determine the effects of magnesium supplementation on gene expression related to insulin and lipid in patients of gestational diabetes.
Objective: The aim of this study is to determine the effects of magnesium supplementation on gene expression related to insulin and lipid in patients of gestational diabetes.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر بیان ژن مرتبط با انسولین و چربی در بیماران مبتلا به دیابت بارداری است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر بیان ژن مرتبط با انسولین و چربی در بیماران مبتلا به دیابت بارداری است.
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Design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive magnesium supplements (n=20) or placebo (n=20).
Design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive magnesium supplements (n=20) or placebo (n=20).
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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. بیماران به دو گروه برای دریافت مکمل منیزیم (20=n) یا پلاسبو (20=n) اختصاص داده خواهند 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. بیماران به دو گروه برای دریافت مکمل منیزیم (20=n) یا پلاسبو (20=n) اختصاص داده خواهند شد
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Population and sample size: Among patients with gestational diabetes referred to gynecology Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria.
Population and sample size: Among patients with gestational diabetes referred to gynecology Clinic affiliated to Arak University of Medical Sciences, 40 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 زنان وابسته به دانشگاه علوم پزشکی اراک، 40 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک زنان وابسته به دانشگاه علوم پزشکی اراک، 40 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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Inclusion criteria: Patients with gestational diabetes; aged 18 to 40 years. Exclusion criteria: Taking magnesium supplements within the past 3 months, needing to insulin therapy during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism, and smokers.
Inclusion criteria: Patients with gestational diabetes; aged 18 to 40 years. Exclusion criteria: Taking magnesium supplements within the past 3 months, needing to insulin therapy during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism, and smokers.
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معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری؛ در محدوده سنی 18 تا 40 سال.معیار خروج از مطالعه: گرفتن مکمل منیزیم در طی سه ماه گذشته، نیاز به انسولین تراپی در طی مداخله، پری اکلامپسی، اکلامپسی، کم و پرکاری تیروئید، سیگاری ها.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری؛ در محدوده سنی 18 تا 40 سال.معیار خروج از مطالعه: گرفتن مکمل منیزیم در طی سه ماه گذشته، نیاز به انسولین تراپی در طی مداخله، پری اکلامپسی، اکلامپسی، کم و پرکاری تیروئید، سیگاری ها.
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Intervention: Patients will be assigned into two groups to receive magnesium (n=20) or placebo (n=20). Magnesium and placebos capsules are similar in shape and size. At the beginning and end of the intervention: 6 weeks.
Intervention: Patients will be assigned into two groups to receive magnesium (n=20) or placebo (n=20). Magnesium and placebos capsules are similar in shape and size. At the beginning and end of the intervention: 6 weeks.
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مداخله مورد مطالعه: بیماران به دو گروه برای دریافت منیزیم (20=n) یا پلاسبو (20=n) اختصاص داده خواهند شد. کپسول های منیزیم و پلاسبو از نظر شکل و اندازه مشابه هستند. زمان مداخله: 6 هفته.
مداخله مورد مطالعه: بیماران به دو گروه برای دریافت منیزیم (20=n) یا پلاسبو (20=n) اختصاص داده خواهند شد. کپسول های منیزیم و پلاسبو از نظر شکل و اندازه مشابه هستند. زمان مداخله: 6 هفته.
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Outcomes: Gene expression related to insulin (primary outcomes) and gene expression related to lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
Outcomes: Gene expression related to insulin (primary outcomes) and gene expression related to lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
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پيامدها: بیان ژن مرتبط با انسولین (پیامدهای اولیه) و بیان ژن مرتبط با لیپید (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: بیان ژن مرتبط با انسولین (پیامدهای اولیه) و بیان ژن مرتبط با لیپید (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Patients with gestational diabetes
Aged 18 to 40 years
Patients with gestational diabetes Aged 18 to 40 years
بیماران مبتلا به دیابت بارداری
در محدوده سنی 18 تا 40 سال
بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال
Taking magnesium supplements within the past 3 months
Needing to insulin therapy during the intervention
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Taking magnesium supplements within the past 3 months Needing to insulin therapy during the intervention Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers
گرفتن مکمل منیزیم در طی سه ماه گذشته
نیاز به انسولین تراپی در طی مداخله
پری اکلامپسی
اکلامپسی
کم و پرکاری تیروئید
سیگاری ها
گرفتن مکمل منیزیم در طی سه ماه گذشته نیاز به انسولین تراپی در طی مداخله پری اکلامپسی اکلامپسی کم و پرکاری تیروئید سیگاری ها
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At study baseline and after balanced blocked randomisation, subjects will be allocated into two groups to take either magnesium supplements (n=20) or placebo (n=20). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after balanced blocked randomisation, subjects will be allocated into two groups to take either magnesium supplements (n=20) or placebo (n=20). Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه و بعد از تصادفی سازی بلوکی بالانس شده، افراد به دو گروه برای دریافت مکمل منیزیم (n=20) و پلاسبو (n=20) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از تصادفی سازی بلوکی بالانس شده، افراد به دو گروه برای دریافت مکمل منیزیم (n=20) و پلاسبو (n=20) 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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Secondary outcomes
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Expressed levels of ox-LDL gene
Expressed levels of LDLR gene
Expressed levels of ox-LDLLDLR gene
سطوح بیان ox-LDL
سطوح بیان LDLR
سطوح بیان ox-LDLLDLR
Recruitment centers
#1
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Street address - English: Emam Khomeyni Avenue, Arak
Street address - Persian: اراک، خیابان امام خمینی
City - English: Arak
City - Persian: اراک
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Kosar 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: Vice chancellor for research, Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3814113634
Phone: +98 86 3223 3823
Fax:
Email: rafiee-g@aums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک Full name of responsible person - English: Mohammad Rafiee Full name of responsible person - Persian: محمد رفیعی Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3814113634 Phone: +98 86 3223 3823 Fax: Email: rafiee-g@aums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Arak University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Position - English: Gynecologist
Position - Persian: متخصص زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 86 8670 2503
Mobile: 00
Fax:
Email: mjamilian@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Arak University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Position - English: Gynecologist
Position - Persian: متخصص زنان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3814113634
Phone: +98 86 8670 2503
Mobile: 00
Fax:
Email: mjamilian@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Arak University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک Full name of responsible person - English: Mehri Jamilian Full name of responsible person - Persian: مهری جمیلیان Position - English: Gynecologist Position - Persian: متخصص زنان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Street address - Persian: اراك، دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی City - English: Arak City - Persian: اراک Province: Markazi Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3814113634 Phone: +98 86 8670 2503 Mobile: 00 Fax: Email: mjamilian@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: PhD of Nutrition
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: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: 00
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: 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: 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: 1771844351
Phone: +98 31 5546 3378
Mobile: 00
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 Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 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: 1771844351 Phone: +98 31 5546 3378 Mobile: 00 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
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: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: 00
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: 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: 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: 1771844351
Phone: +98 31 5546 3378
Mobile: 00
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 Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 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: 1771844351 Phone: +98 31 5546 3378 Mobile: 00 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
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.
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
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 magnesium supplementation on gene expression related to insulin and lipid in patients of gestational diabetes.
Design
Design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive magnesium supplements (n=20) or placebo (n=20).
Settings and conduct
Population and sample size: Among patients with gestational diabetes referred to gynecology Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes; aged 18 to 40 years. Exclusion criteria: Taking magnesium supplements within the past 3 months, needing to insulin therapy during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism, and smokers.
Intervention groups
Intervention: Patients will be assigned into two groups to receive magnesium (n=20) or placebo (n=20). Magnesium and placebos capsules are similar in shape and size. At the beginning and end of the intervention: 6 weeks.
Main outcome variables
Outcomes: Gene expression related to insulin (primary outcomes) and gene expression related to lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201704235623N111
Registration date:2017-04-29, 1396/02/09
Registration timing:retrospective
Last update:2019-09-21, 1398/06/30
Update count:1
Registration date
2017-04-29, 1396/02/09
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
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-03-07, 1395/12/17
Expected recruitment end date
2017-04-06, 1396/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of magnesium supplementation compared with the placebo on gene expression related to insulin and lipid in women with gestational diabetes
Public title
Effect of supplementation in treatment of women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gestational diabetes
Aged 18 to 40 years
Exclusion criteria:
Taking magnesium supplements within the past 3 months
Needing to insulin therapy during the intervention
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after balanced blocked randomisation, subjects will be allocated into two groups to take either magnesium supplements (n=20) or placebo (n=20). 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
Randomization will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.ARAKMU.REC.1395.440
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Expressed levels of PPAR-γ
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of GLUT-1
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Expressed levels of LDLR gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of Lp(a) gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: Magnesium supplements (21st Century, Arizona, USA), 250 mg, daily, for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule, daily for 6 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
jamilian.mehri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
rafiee-g@aums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 8670 2503
Fax
Email
mjamilian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available