Clinical trial of the effect of Q10 supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with polycystic ovary syndrome
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Protocol summary
Objective: The aim of this study is to determine the effects of Q10 supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with polycystic ovary syndrome of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either Q10 (n=30) or placebo (n=30). Q10 and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of Q10 supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with polycystic ovary syndrome of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either Q10 (n=30) or placebo (n=30). Q10 and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری کیوتن بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل کیوتن (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل کیوتن و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری کیوتن بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل کیوتن (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل کیوتن و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of Q10 supplementation on levels of gene expression related with glycemic control and inflammatory factors, and metabolic profiles in patients with polycystic ovary syndrome.
The aim of this study is to determine the effects of Q10 supplementation on levels of gene expression related with glycemic control and inflammatory factors, and metabolic profiles in patients with polycystic ovary syndrome.
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هدف این مطالعه تعیین اثرات مکمل یاری کیوتن بر سطوح بیان ژن مرتبط با کنترل گلیسمیک، فاکتورهای التهابی و پروفایل های متابولیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
هدف این مطالعه تعیین اثرات مکمل یاری کیوتن بر سطوح بیان ژن مرتبط با کنترل گلیسمیک، فاکتورهای التهابی و پروفایل های متابولیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
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Parallel double-blind (both patients and researchers) clinical trial
Parallel double-blind (both patients and researchers) clinical trial
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کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
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Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences and Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, 60 patients (for metabolic profiles and 40 patients for gene expression) will be selected according to inclusion and exclusion criteria.
Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences and Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, 60 patients (for metabolic profiles and 40 patients for gene expression) will be selected according to inclusion and exclusion criteria.
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از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک و بیمارستان شهدای خلیج فارس وابسته به دانشگاه علوم پزشکی بوشهر، 60 بیمار (برای پروفایل های متابولیک و 40 بیمار برای بیان ژن) بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک و بیمارستان شهدای خلیج فارس وابسته به دانشگاه علوم پزشکی بوشهر، 60 بیمار (برای پروفایل های متابولیک و 40 بیمار برای بیان ژن) بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinaemia, thyroid dysfunction, diabetes or impaired glucose tolerance, gastrointestinal problems, no hormonal treatments in the previous 6 months in the study.
Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinaemia, thyroid dysfunction, diabetes or impaired glucose tolerance, gastrointestinal problems, no hormonal treatments in the previous 6 months in the study.
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یماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر خواهد بود: زنان باردار، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، افزایش پرولاکتین خون، اختلال در عملکرد تیروئید، دیابت یا اختلال در تحمل گلوکز، مشکلات معده ای روده ای، درمان های غیر هورمونی در 6 ماه قبل از مطالعه.
یماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر خواهد بود: زنان باردار، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، افزایش پرولاکتین خون، اختلال در عملکرد تیروئید، دیابت یا اختلال در تحمل گلوکز، مشکلات معده ای روده ای، درمان های غیر هورمونی در 6 ماه قبل از مطالعه.
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Patients will be assigned to receive either Q10 (n=30) or placebo (n=30) for metabolic profiles, and to receive either Q10 (n=20) or placebo (n=20) for gene expression.
Patients will be assigned to receive either Q10 (n=30) or placebo (n=30) for metabolic profiles, and to receive either Q10 (n=20) or placebo (n=20) for gene expression.
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بیماران برای دریافت مکمل کیوتن (30=n) یا پلاسبو (30=n) برای پروفایل های متابولیک و برای دریافت مکمل کیوتن (20=n) یا پلاسبو (20=n) برای بیان ژن تقسیم خواهند شد.
بیماران برای دریافت مکمل کیوتن (30=n) یا پلاسبو (30=n) برای پروفایل های متابولیک و برای دریافت مکمل کیوتن (20=n) یا پلاسبو (20=n) برای بیان ژن تقسیم خواهند شد.
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Levels of gene expression related with glycemic control and insulin metabolism (primary outcomes), and gene expression related to inflammatory factors and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
Levels of gene expression related with glycemic control and insulin metabolism (primary outcomes), and gene expression related to inflammatory factors and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
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سطوح بیان ژن مرتبط با کنترل گلیسمیک و متابولیسم انسولین (پیامدهای اولیه)، بیان ژن مرتبط با فاکتورهای التهابی و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
سطوح بیان ژن مرتبط با کنترل گلیسمیک و متابولیسم انسولین (پیامدهای اولیه)، بیان ژن مرتبط با فاکتورهای التهابی و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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2016-04-20, 1395/02/01
2016-04-25, 1395/02/06
2016-04-2025 00:00:00
2016-05-09, 1395/02/20
2016-05-05, 1395/02/16
2016-05-0905 00:00:00
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Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
Patients with PCOS according to Rotterdam criteria
Aged 18 to 40 years
Patients with PCOS according to Rotterdam criteria Aged 18 to 40 years
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
سن 18 تا 40 سال
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام سن 18 تا 40 سال
Pregnant women
Adrenal hyperplasia
Androgen-secreting tumors
Hyperprolactinaemia
Thyroid dysfunction
Diabetes or impaired glucose tolerance
Gastrointestinal problems
No hormonal treatments in the previous 6 months in the study
Pregnant women Adrenal hyperplasia Androgen-secreting tumors Hyperprolactinaemia Thyroid dysfunction Diabetes or impaired glucose tolerance Gastrointestinal problems No hormonal treatments in the previous 6 months in the study
زنان باردار
هیپرپلازی آدرنال
تومورهای ترشح کننده آندروژن
افزایش پرولاکتین خون
اختلال در عملکرد تیروئید
دیابت یا اختلال در تحمل گلوکز
مشکلات معده ای روده ای
درمان های غیر هورمونی در 6 ماه قبل از مطالعه
زنان باردار هیپرپلازی آدرنال تومورهای ترشح کننده آندروژن افزایش پرولاکتین خون اختلال در عملکرد تیروئید دیابت یا اختلال در تحمل گلوکز مشکلات معده ای روده ای درمان های غیر هورمونی در 6 ماه قبل از مطالعه
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Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.
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بیماران به طور تصادفی به دو گروه تخصیص داده خواهند شد. یک لیست اعداد تصادفی از 1 تا 60 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به دو گروه مداخله تخصیص داده خواهند شد.
بیماران به طور تصادفی به دو گروه تخصیص داده خواهند شد. یک لیست اعداد تصادفی از 1 تا 60 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به دو گروه مداخله تخصیص داده خواهند شد.
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will be allocated the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will be allocated the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، بطری های شماره گذاری شده کپسول ها را به شرکت کنندگان تخصیص خواهد داد. مکمل ها و پلاسبو در شرکت داروسازی در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود. بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، بطری های شماره گذاری شده کپسول ها را به شرکت کنندگان تخصیص خواهد داد. مکمل ها و پلاسبو در شرکت داروسازی در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود. بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود.
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Primary outcomes
#1
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Serum insulin
Serum insulin
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انسولین سرم
انسولین سرم
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Eliza
Eliza
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الایزا
الایزا
#2
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Insulin resistance
Insulin resistance
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مقاومت به انسولین
مقاومت به انسولین
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Calculation with HOMA formula
Calculation with HOMA formula
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محاسبه با فرمول HOMA
محاسبه با فرمول HOMA
Secondary outcomes
#1
Expressed levels of SOD gene
Expressed levels of TGFB gene
Expressed levels of SODTGFB gene
سطوح بیان ژن SOD
سطوح بیان ژن TGFB
سطوح بیان ژن SODTGFB
#2
Expressed levels of IL-6 gene
Expressed levels of IL-8 gene
Expressed levels of IL-68 gene
سطوح بیان ژن اینترلوکین 6
سطوح بیان ژن اینترلوکین 8
سطوح بیان ژن اینترلوکین 68
#3
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Expressed levels of LDLR gene
Expressed levels of LDLR gene
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سطوح بیان ژن LDLR
سطوح بیان ژن LDLR
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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PCR
PCR
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PCR
PCR
#4
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Expressed levels of Lp(a) gene
Expressed levels of Lp(a) gene
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سطوح بیان ژن Lp(a)
سطوح بیان ژن Lp(a)
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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PCR
PCR
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PCR
PCR
#5
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Fasting plasma glucose
Fasting plasma glucose
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قند خون ناشتا
قند خون ناشتا
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#6
empty
Triglycerides
Triglycerides
empty
تری گلیسرید
تری گلیسرید
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#7
empty
VLDL-cholesterol
VLDL-cholesterol
empty
کلسترول VLDL
کلسترول VLDL
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#8
empty
Total cholesterol
Total cholesterol
empty
کلسترول توتال
کلسترول توتال
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#9
empty
LDL-cholesterol
LDL-cholesterol
empty
کلسترول LDL
کلسترول LDL
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#10
empty
HDL-cholesterol
HDL-cholesterol
empty
کلسترول HDL
کلسترول HDL
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
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 6933
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 6933 Fax: Email: jamilian.mehri@gmail.com Web page address:
#2
Name of recruitment center - English: Persian Gulf Martyrs Hospital
Name of recruitment center - Persian: بیمارستان شهدای خلیج فارس
Full name of responsible person - English: Dr Elham Rahmani
Full name of responsible person - Persian: دکتر الهام رحمانی
Street address - English: Persian Gulf Martyrs Hospital, Borj square, Borj Blvd
Street address - Persian: میدان برج، بلوار برج، بیمارستان شهدای خلیج فارس
City - English: Boushehr
City - Persian: بوشهر
Province: Boushehr
Country: Iran (Islamic Republic of)
Postal code: 7518759577
Phone: +98 77 3345 0089
Fax:
Email: rahmani-e@bums.ac.ir
Web page address:
Name of recruitment center - English: Persian Gulf Martyrs Hospital Name of recruitment center - Persian: بیمارستان شهدای خلیج فارس Full name of responsible person - English: Dr Elham Rahmani Full name of responsible person - Persian: دکتر الهام رحمانی Street address - English: Persian Gulf Martyrs Hospital, Borj square, Borj Blvd Street address - Persian: میدان برج، بلوار برج، بیمارستان شهدای خلیج فارس City - English: Boushehr City - Persian: بوشهر Province: Boushehr Country: Iran (Islamic Republic of) Postal code: 7518759577 Phone: +98 77 3345 0089 Fax: Email: rahmani-e@bums.ac.ir 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: 3848176341
Phone: +98 86 3223 3823
Fax:
Email: research@arakmu.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: 3848176341 Phone: +98 86 3223 3823 Fax: Email: research@arakmu.ac.ir Web page address:
100
33
10033
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
#2
contact.organization_id:
Name of organization / entity - English: Vice chancellor of research, Bushehr University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی بوشهر، معاونت پژوهشی
Full name of responsible person - English: Dr Afshin Ostevar
Full name of responsible person - Persian: دکتر افشین استوار
Street address - English: Bahmani Campus, University of Medical Sciences, Sabzabad Blvd
Street address - Persian: بلوار سبزآباد، دانشگاه علوم پزشکی، پردیس بهمنی
City - English: Boushehr
City - Persian: بوشهر
Province: Boushehr
Country: Iran (Islamic Republic of)
Postal code: 7514633341
Phone: +98 77 3345 0089
Fax:
Email: research@bums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor of research, Bushehr University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی بوشهر، معاونت پژوهشی Full name of responsible person - English: Dr Afshin Ostevar Full name of responsible person - Persian: دکتر افشین استوار Street address - English: Bahmani Campus, University of Medical Sciences, Sabzabad Blvd Street address - Persian: بلوار سبزآباد، دانشگاه علوم پزشکی، پردیس بهمنی City - English: Boushehr City - Persian: بوشهر Province: Boushehr Country: Iran (Islamic Republic of) Postal code: 7514633341 Phone: +98 77 3345 0089 Fax: Email: research@bums.ac.ir Web page address:
empty
empty
empty
33
33
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
empty
Vice chancellor of research, Bushehr University of Medical Sciences
Vice chancellor of research, Bushehr University of Medical Sciences
empty
دانشگاه علوم پزشکی بوشهر، معاونت پژوهشی
دانشگاه علوم پزشکی بوشهر، معاونت پژوهشی
#3
contact.organization_id:
Name of organization / entity - English: Vice chancellor of research, Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان، معاونت پژوهشی
Full name of responsible person - English: Dr Gholamali Hamidi
Full name of responsible person - Persian: دکتر غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor of research, Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان، معاونت پژوهشی Full name of responsible person - English: Dr Gholamali Hamidi Full name of responsible person - Persian: دکتر غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 2999 Fax: Email: research@kaums.ac.ir Web page address:
empty
empty
empty
34
34
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
empty
Vice chancellor of research, Kashan University of Medical Sciences
Vice chancellor of research, Kashan University of Medical Sciences
empty
دانشگاه علوم پزشکی کاشان، معاونت پژوهشی
دانشگاه علوم پزشکی کاشان، معاونت پژوهشی
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work:
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English:
City - Persian:
Province:
Province - English:
Province - Persian:
contact.provinces_available:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Mobile: +98 913 361 5446
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: دکترای تغذیه Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 2999 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: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 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: PhD of Nutrition 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: 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: +98 913 361 5446 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: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: 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: +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: 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: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
na
na
undecided
undecided
na
na
na
na
na
na
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
The aim of this study is to determine the effects of Q10 supplementation on levels of gene expression related with glycemic control and inflammatory factors, and metabolic profiles in patients with polycystic ovary syndrome.
Design
Parallel double-blind (both patients and researchers) clinical trial
Settings and conduct
Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences and Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, 60 patients (for metabolic profiles and 40 patients for gene expression) will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinaemia, thyroid dysfunction, diabetes or impaired glucose tolerance, gastrointestinal problems, no hormonal treatments in the previous 6 months in the study.
Intervention groups
Patients will be assigned to receive either Q10 (n=30) or placebo (n=30) for metabolic profiles, and to receive either Q10 (n=20) or placebo (n=20) for gene expression.
Main outcome variables
Levels of gene expression related with glycemic control and insulin metabolism (primary outcomes), and gene expression related to inflammatory factors and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number:IRCT201605225623N80
Registration date:2016-06-04, 1395/03/15
Registration timing:retrospective
Last update:2020-08-26, 1399/06/05
Update count:1
Registration date
2016-06-04, 1395/03/15
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
2016-04-25, 1395/02/06
Expected recruitment end date
2016-05-05, 1395/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of Q10 supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with PCOS according to Rotterdam criteria
Aged 18 to 40 years
Exclusion criteria:
Pregnant women
Adrenal hyperplasia
Androgen-secreting tumors
Hyperprolactinaemia
Thyroid dysfunction
Diabetes or impaired glucose tolerance
Gastrointestinal problems
No hormonal treatments in the previous 6 months in the study
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will be allocated the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2016-04-24, 1395/02/05
Ethics committee reference number
IR.ARAKMU.REC.1395.35
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Expressed levels of PPAR-γ
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of GLUT1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
3
Description
Serum insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Eliza
4
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation with HOMA formula
Secondary outcomes
1
Description
Expressed levels of TNFα gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of TGFB gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
3
Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
4
Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
5
Description
Expressed levels of LDLR gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
6
Description
Expressed levels of Lp(a) gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
7
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
VLDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
11
Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
12
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: 100 mg Q10 (Nature, New York, USA), once a day, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 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 6933
Email
jamilian.mehri@gmail.com
2
Recruitment center
Name of recruitment center
Persian Gulf Martyrs Hospital
Full name of responsible person
Dr Elham Rahmani
Street address
Persian Gulf Martyrs Hospital, Borj square, Borj Blvd
City
Boushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0089
Email
rahmani-e@bums.ac.ir
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
3848176341
Phone
+98 86 3223 3823
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
33
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
2
Sponsor
Name of organization / entity
Vice chancellor of research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostevar
Street address
Bahmani Campus, University of Medical Sciences, Sabzabad Blvd
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0089
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor of research, Bushehr University of Medical Sciences
Proportion provided by this source
33
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
3
Sponsor
Name of organization / entity
Vice chancellor of research, Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, 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?
No
Title of funding source
Vice chancellor of research, Kashan University of Medical Sciences
Proportion provided by this source
34
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
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
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
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_z@kaums.ac.ir
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_z@kaums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available