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Protocol summary
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 milligram per deciliter and proteinuria 30-300 milligram per deciliter (micro-albuminuria) and Glomerular Filtration Rate more than 90 milliliter per minute will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
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This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 milligram per deciliter and proteinuria 30-300 milligram per deciliter (micro-albuminuria) and Glomerular Filtration Rate more than 90 milliliter per minute will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
مطالعه حاضر با هدف بررسی تأثیر مصرف مکمل منیزیم بر عملکرد کلیوی، مقاومت انسولینی و پروفایل متابولیکی در بیماران دیابتی مبتلا به نفروپاتی صورت خواهد گرفت. این مطالعه یک مطالعه مداخلهای تصادفی سازی شده دوسوکور خواهد بود که از ابتدای خرداد 1393 تا خرداد 1394 در شهر اصفهان انجام خواهد شد. سطح کراتینین سرم به عنوان یک متغیر کلیدی درنظر گرفته می شود و حجم نمونه 80 نفر (40 نفر گروه کنترل و 40 نفر گروه بیمار) محاسبه گردیده است. افراد بالاتر از 18 سال با تشخیص نفروپاتی دیابتی از طریق قند خون ناشتای بالاتر از 126 میلیگرم بر دسی لیتر و پروتئینوری 300-30 میلیگرم بر دسی لیتر (میکروآلبومینوری) و فیلتراسیون گلومرولی بیشتر از 90 میلی لیتر بر دقیقه انتخاب خواهند شد. یک گروه از افراد مورد مطالعه مکمل منیزیم (250 میلیگرم) گروه دیگر پلاسبوی منیزیم که از نظر رنگ، بو و ظاهر شبیه کپسول های منیزیم باشد، بمدت 12 هفته دریافت خواهند کرد. در طی مطالعه، تمام افراد مورد مطالعه 4 ثبت فعالیت بدنی و 4 ثبت غذایی تکمیل خواهند کرد. در ابتدا و انتهای مطالعه، شاخص های پیامد (شاخص های مربوط به پروفایل متابولیکی، پرفایل کلیوی و شاخص التهابی) اندازه گیری خواهد شد. همچنین شاخصهای آنتروپومتریک شامل قد و وزن، در ابتدای مطالعه و 12 هفته بعد از مداخله اندازهگیری خواهد شد.
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مطالعه حاضر با هدف بررسی تأثیر مصرف مکمل منیزیم بر عملکرد کلیوی، مقاومت انسولینی و پروفایل متابولیکی در بیماران دیابتی مبتلا به نفروپاتی صورت خواهد گرفت. این مطالعه یک مطالعه مداخلهای تصادفی سازی شده دوسوکور خواهد بود که از ابتدای خرداد 1393 تا خرداد 1394 در شهر اصفهان انجام خواهد شد. سطح کراتینین سرم به عنوان یک متغیر کلیدی درنظر گرفته می شود و حجم نمونه 80 نفر (40 نفر گروه کنترل و 40 نفر گروه بیمار) محاسبه گردیده است. افراد بالاتر از 18 سال با تشخیص نفروپاتی دیابتی از طریق قند خون ناشتای بالاتر از 126 میلیگرم بر دسی لیتر و پروتئینوری 300-30 میلیگرم بر دسی لیتر (میکروآلبومینوری) و فیلتراسیون گلومرولی بیشتر از 90 میلی لیتر بر دقیقه انتخاب خواهند شد. یک گروه از افراد مورد مطالعه مکمل منیزیم (250 میلیگرم) گروه دیگر پلاسبوی منیزیم که از نظر رنگ، بو و ظاهر شبیه کپسول های منیزیم باشد، بمدت 12 هفته دریافت خواهند کرد. در طی مطالعه، تمام افراد مورد مطالعه 4 ثبت فعالیت بدنی و 4 ثبت غذایی تکمیل خواهند کرد. در ابتدا و انتهای مطالعه، شاخص های پیامد (شاخص های مربوط به پروفایل متابولیکی، پرفایل کلیوی و شاخص التهابی) اندازه گیری خواهد شد. همچنین شاخصهای آنتروپومتریک شامل قد و وزن، در ابتدای مطالعه و 12 هفته بعد از مداخله اندازهگیری خواهد شد.
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This study aimed to examine the effect of magnesium supplementation on renal function, insulin resistance and metabolic profiles in patients with diabetic nephropathy.
This study aimed to examine the effect of magnesium supplementation on renal function, insulin resistance and metabolic profiles in patients with diabetic nephropathy.
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این مطالعه با هدف تعیین تأثیر مکمل یاری با منیزیم بر عملکرد کلیوی، مقاومت انسولینی و پروفایل متابولیک در بیماران مبتلا به نفروپاتی دیابتی انجام گردید.
این مطالعه با هدف تعیین تأثیر مکمل یاری با منیزیم بر عملکرد کلیوی، مقاومت انسولینی و پروفایل متابولیک در بیماران مبتلا به نفروپاتی دیابتی انجام گردید.
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This is a double-blind randomized clinical trial
This is a double-blind randomized clinical trial
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یک مداخله بالینی تصادفی سازی شده دوسو کور
یک مداخله بالینی تصادفی سازی شده دوسو کور
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urinary albumin to creatinine ratio (UACR) is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
urinary albumin to creatinine ratio (UACR) is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
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نسبت آلبومین به کراتینین ادرار به عنوان متغیر کلیدی در نظر گرفته شد و حجم نمونه 80 نفر تخمین زده شد (40 نفر در گروه کنترل و 40 نفر در گروه بیمار). تمامی افراد 4 ثبت فعالیت فیزیکی و 4 ثبت غذایی انجام خواهند داد. اندازه گیری های پیامد شامل پروفایل متابولیک، کلیوی و التهابی و همچنین مقادیر آنتروپومتری در ابتدا و انتهاب مطالعه اندازه گیری خواهد شد.
نسبت آلبومین به کراتینین ادرار به عنوان متغیر کلیدی در نظر گرفته شد و حجم نمونه 80 نفر تخمین زده شد (40 نفر در گروه کنترل و 40 نفر در گروه بیمار). تمامی افراد 4 ثبت فعالیت فیزیکی و 4 ثبت غذایی انجام خواهند داد. اندازه گیری های پیامد شامل پروفایل متابولیک، کلیوی و التهابی و همچنین مقادیر آنتروپومتری در ابتدا و انتهاب مطالعه اندازه گیری خواهد شد.
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Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 milligram per deciliter and proteinuria 30-300 milligram per deciliter (micro-albuminuria) and Glomerular Filtration Rate more than 90 milliliter per minute will be chosen.
Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 milligram per deciliter and proteinuria 30-300 milligram per deciliter (micro-albuminuria) and Glomerular Filtration Rate more than 90 milliliter per minute will be chosen.
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بیماران مبتلا به نفروپاتی دیابتی 18 سال به بالا که قندخون ناشتای بیشتر از 126 میلیگرم در دسی لیتر و پروتئینوری 30 تا 300 میلیگرم در دسی لیتر (میکروآلبومینوری) و میزان فیلتراسیون گلومرولی بیشتر از 90 میلیگرم در دقیقه انتخاب خواهند شد.
بیماران مبتلا به نفروپاتی دیابتی 18 سال به بالا که قندخون ناشتای بیشتر از 126 میلیگرم در دسی لیتر و پروتئینوری 30 تا 300 میلیگرم در دسی لیتر (میکروآلبومینوری) و میزان فیلتراسیون گلومرولی بیشتر از 90 میلیگرم در دقیقه انتخاب خواهند شد.
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Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks.
Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks.
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بیماران در گروه مکمل، منیزیم به میزان 250 میلیگرم و بیماران در گروه دیگر دارونمای مشابه قرص های منیزیم از نظر رنگ، بو و ظاهر به مدت 12 هفته دریافت می کنند.
بیماران در گروه مکمل، منیزیم به میزان 250 میلیگرم و بیماران در گروه دیگر دارونمای مشابه قرص های منیزیم از نظر رنگ، بو و ظاهر به مدت 12 هفته دریافت می کنند.
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metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
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پروفایل متابولیک، کلیوی و التهابی و همچنین مقادیر آنتروپومتری در ابتدا و انتهاب مطالعه اندازه گیری خواهد شد.
پروفایل متابولیک، کلیوی و التهابی و همچنین مقادیر آنتروپومتری در ابتدا و انتهاب مطالعه اندازه گیری خواهد شد.
General information
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80
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2014-10-06, 1393/07/14
2014-10-06 00:00:00
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2016-04-23, 1395/02/04
2016-04-23 00:00:00
More than 18 years old
Diabetic nephropathy
Blood glucose more than 126 milligram per decilite
Proteinuria between 30 to 300 milligram per deciliter (micro-albuminuria)
Glomerular Filtration Rate more than 90 milliliter per minute
Not having hypothyroidism and hyperthyroidism; Not having any urine duct infection; Not having any feverish infection; Not using cigarette or other drugs; Not having liver disease; Not having cancer; Not having any inflammatory disease
Not losing weight more than 4 kilogram during last 3 months
Not using any magnesium-rich supplement
More than 18 years old Diabetic nephropathy Blood glucose more than 126 milligram per decilite Proteinuria between 30 to 300 milligram per deciliter (micro-albuminuria) Glomerular Filtration Rate more than 90 milliliter per minute Not having hypothyroidism and hyperthyroidism; Not having any urine duct infection; Not having any feverish infection; Not using cigarette or other drugs; Not having liver disease; Not having cancer; Not having any inflammatory disease Not losing weight more than 4 kilogram during last 3 months Not using any magnesium-rich supplement
افراد بالاتر از 18 سال
دارای نفروپاتی دیابتی
قند خون ناشتای بالاتر از 126 میلیگرم برای هر دسی لیتر
پروتئینوری 300-30 میلیگرم برای هر دسی لیتر (میکروآلبومینوری)
بیشتر از 90 میلی لیتر بر دقیقه
عدم کمکاری و پرکاری تیروئید؛ عدم عفونت مجاری ادراری، عدم هرنوع عفونت همراه با تب؛ عدم مصرف سیگار یا سایر مواد مخدر؛ عدم بیماری کبدی؛ عدم سرطان؛ عدم بیماریهای التهابی
عدم تغییرات وزن بیش از 4 کیلوگرم در طی 3 ماه اخیر
عدم استفاده از هر نوع مکمل حاوی منیزیم
افراد بالاتر از 18 سال دارای نفروپاتی دیابتی قند خون ناشتای بالاتر از 126 میلیگرم برای هر دسی لیتر پروتئینوری 300-30 میلیگرم برای هر دسی لیتر (میکروآلبومینوری) بیشتر از 90 میلی لیتر بر دقیقه عدم کمکاری و پرکاری تیروئید؛ عدم عفونت مجاری ادراری، عدم هرنوع عفونت همراه با تب؛ عدم مصرف سیگار یا سایر مواد مخدر؛ عدم بیماری کبدی؛ عدم سرطان؛ عدم بیماریهای التهابی عدم تغییرات وزن بیش از 4 کیلوگرم در طی 3 ماه اخیر عدم استفاده از هر نوع مکمل حاوی منیزیم
Changing medicine doses
failure to adherence (using less than 75 percent of medicines)
Changing medicine doses failure to adherence (using less than 75 percent of medicines)
عدم استفاده از هر نوع مکمل حاوی منیزیم معیارهای خروج
تغییر در دوز داروها؛ آریتمی قلبی؛ عدم تبعیت (مصرف کمتر از 75 درصد قرصها)
عدم استفاده از هر نوع مکمل حاوی منیزیم معیارهای خروج تغییر در دوز داروها؛ آریتمی قلبی؛ عدم تبعیت (مصرف کمتر از 75 درصد قرصها)
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After stratification for age, sex, type and dose of medication and BMI, subjects were randomly assigned to receive either magnesium supplements or placebo.
After stratification for age, sex, type and dose of medication and BMI, subjects were randomly assigned to receive either magnesium supplements or placebo.
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بعد از طبقهبندی و همسان سازی افراد براساس دز و نوع داروی مصرفی، سن و جنس، این افراد به طور تصادفی به دو گروه مکمل و دارونما تقسیم شدند.
بعد از طبقهبندی و همسان سازی افراد براساس دز و نوع داروی مصرفی، سن و جنس، این افراد به طور تصادفی به دو گروه مکمل و دارونما تقسیم شدند.
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Placebo was similar in appearance (color, shape, size and packaging) with supplements. Patients were indicated by numbers for principle investigator. Supplement or placebo were handed over the participants by two other health provider not related to the trial.
Placebo was similar in appearance (color, shape, size and packaging) with supplements. Patients were indicated by numbers for principle investigator. Supplement or placebo were handed over the participants by two other health provider not related to the trial.
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از آنجا که دارونما از نظر رنگ، ظاهر، اندازه و بسته بندی کاملا شبیه مکمل بود شرکت کنندگان نمی دانستند در کدام گروه قرار دارند. همچنین محقق اصلی افراد را براساس کد می شناخت و دو نفر که خارج از طرح بودند وظیفه توزیع مکمل و دارونما را به عهده داشتند.
از آنجا که دارونما از نظر رنگ، ظاهر، اندازه و بسته بندی کاملا شبیه مکمل بود شرکت کنندگان نمی دانستند در کدام گروه قرار دارند. همچنین محقق اصلی افراد را براساس کد می شناخت و دو نفر که خارج از طرح بودند وظیفه توزیع مکمل و دارونما را به عهده داشتند.
Primary outcomes
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Serum Creatinine
albumin to creatinine ratio (UACR)
Serum Creatininealbumin to creatinine ratio (UACR)
سطح کراتینین سرم
نسبت آلبومین به کراتینین
سطحنسبت آلبومین به کراتینین سرم
Secondary outcomes
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creatinine
creatinine
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کراتینین
کراتینین
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Baseline, week 12
Baseline, week 12
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ابتدای مطالعه، هفته 12
ابتدای مطالعه، هفته 12
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Commercial kits
Commercial kits
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کیت تجاری
کیت تجاری
Recruitment centers
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Name of recruitment center - English: Isfahan University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Ahmad Esmaeilzadeh
Full name of responsible person - Persian: احمد اسماعیل زاده
Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
City - English: Isfahan
City - Persian: اصفهان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Isfahan University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Ahmad Esmaeilzadeh
Full name of responsible person - Persian: احمد اسماعیل زاده
Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81745-151
Phone: +98 31 3792 3151
Fax:
Email: a.esmaillzadeh@gmail.com
Web page address:
Name of recruitment center - English: Isfahan University of Medical Sciences Name of recruitment center - Persian: دانشگاه علوم پزشکی اصفهان Full name of responsible person - English: Ahmad Esmaeilzadeh Full name of responsible person - Persian: احمد اسماعیل زاده Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81745-151 Phone: +98 31 3792 3151 Fax: Email: a.esmaillzadeh@gmail.com Web page address:
Sponsors / Funding sources
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contact.organization_id:
Name of organization / entity - English: Isfahan University of medical sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Payman Adibi
Full name of responsible person - Persian: پیمان ادیبی
Street address - English: Research Assistance, Isfahan University of Medical sciences, Av. Hezarjerib, Isfahan, Iran
Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، معاونت پژوهشی
City - English: Isfahan
City - Persian: اصفهان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Isfahan University of medical sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Payman Adibi
Full name of responsible person - Persian: پیمان ادیبی
Street address - English: Research Assistance, Isfahan University of Medical sciences, Av. Hezarjerib, Isfahan, Iran
Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، معاونت پژوهشی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81745-151
Phone: +98 31 3792 3151
Fax:
Email: a.esmaillzadeh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Isfahan University of medical sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان Full name of responsible person - English: Payman Adibi Full name of responsible person - Persian: پیمان ادیبی Street address - English: Research Assistance, Isfahan University of Medical sciences, Av. Hezarjerib, Isfahan, Iran Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، معاونت پژوهشی City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81745-151 Phone: +98 31 3792 3151 Fax: Email: a.esmaillzadeh@gmail.com Web page address:
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Public
public
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Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Isfahan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Ahmad Esmaeilzade
Full name of responsible person - Persian: احمد اسماعیل زاده
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
City - English: Isfahan
City - Persian: اصفهان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 1792 2776
Mobile: +98 912 606 9300
Fax:
Email: esmaillzadeh@hlth.mui.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Isfahan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Ahmad Esmaeilzade
Full name of responsible person - Persian: احمد اسماعیل زاده
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81745-151
Phone: +98 31 1792 2776
Mobile: +98 912 606 9300
Fax:
Email: esmaillzadeh@hlth.mui.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Isfahan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان Full name of responsible person - English: Ahmad Esmaeilzade Full name of responsible person - Persian: احمد اسماعیل زاده Position - English: Associate Professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran Street address - Persian: ایران، اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81745-151 Phone: +98 31 1792 2776 Mobile: +98 912 606 9300 Fax: Email: esmaillzadeh@hlth.mui.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
Full name of responsible person - English: Ahmad Esmaeilzade
Full name of responsible person - Persian: احمد اسماعیل زاده
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
Street address - Persian: اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
City - English: Isfahan
City - Persian: اصفهان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 1792 2776
Mobile: 00
Fax:
Email: esmaillzadeh@hlth.mui.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
Full name of responsible person - English: Ahmad Esmaeilzade
Full name of responsible person - Persian: احمد اسماعیل زاده
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
Street address - Persian: اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81745-151
Phone: +98 31 1792 2776
Mobile: +98 913 101 7626
Fax:
Email: esmaillzadeh@hlth.mui.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه Full name of responsible person - English: Ahmad Esmaeilzade Full name of responsible person - Persian: احمد اسماعیل زاده Position - English: Associate Professor Position - Persian: دانشیاراستاد Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan Street address - Persian: اصفهان، خیابان هزارجریب، دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81745-151 Phone: +98 31 1792 2776 Mobile: 00+98 913 101 7626 Fax: Email: esmaillzadeh@hlth.mui.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: College of Nutrition, Isfahan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
Full name of responsible person - English: Mehdi Sadeghian
Full name of responsible person - Persian: مهدی صادقیان
Position - English: Bachelor
Position - Persian: کارشناس تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان
City - English: Isfahan
City - Persian: اصفهان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +31 17922720
Mobile: +91 31017626
Fax:
Email: vipmaster1369@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: College of Nutrition, Isfahan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه
Full name of responsible person - English: Mehdi Sadeghian
Full name of responsible person - Persian: مهدی صادقیان
Position - English: Bachelor
Position - Persian: کارشناس تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81745-151
Phone: +31 17922720
Mobile: +91 31017626
Fax:
Email: vipmaster1369@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: College of Nutrition, Isfahan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اصفهان، دانشکده تغذیه Full name of responsible person - English: Mehdi Sadeghian Full name of responsible person - Persian: مهدی صادقیان Position - English: Bachelor Position - Persian: کارشناس تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81745-151 Phone: +31 17922720 Mobile: +91 31017626 Fax: Email: vipmaster1369@gmail.com Web page address:
Sharing plan
no
no
no
no
no
no
no
no
yes
yes
no
no
no
no
empty
There is no data sharing agreement from the related organization.
There is no data sharing agreement from the related organization.
empty
موافقت نامه ای جهت منتشر کردن داده ها از سازمان ذی ربط نداریم.
موافقت نامه ای جهت منتشر کردن داده ها از سازمان ذی ربط نداریم.
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The effect of oral magnesium supplementation on micro-albuminuria and metabolic status of patients with diabetic nephropathy: a double-blind randomized controlled clinical trial
The primary outcome measure only is to be shared
The effect of oral magnesium supplementation on micro-albuminuria and metabolic status of patients with diabetic nephropathy: a double-blind randomized controlled clinical trial The primary outcome measure only is to be shared
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تأثیر مصرف مکمل منیزیم بر عملکرد کلیوی، مقاومت انسولینی و پروفایل متابولیکی در بیماران دیابتی مبتلا به نفروپاتی در مرحله میکروآلبومینوری
فقط یافته های اصلی منتشر می شوند.
تأثیر مصرف مکمل منیزیم بر عملکرد کلیوی، مقاومت انسولینی و پروفایل متابولیکی در بیماران دیابتی مبتلا به نفروپاتی در مرحله میکروآلبومینوری فقط یافته های اصلی منتشر می شوند.
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January 2017
January 2017
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شرود دسترسی به یافته ها از سال 1396
شرود دسترسی به یافته ها از سال 1396
empty
for people working in academic institutions
for people working in academic institutions
empty
برای محققین شاغل در موسسات دانشگاهی و علمی
برای محققین شاغل در موسسات دانشگاهی و علمی
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No other criteria are not provided.
No other criteria are not provided.
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معیار دیگری نیاز نیست.
معیار دیگری نیاز نیست.
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mehdisad69@gmail.com
mehdisad69@gmail.com
empty
mehdisad69@gmail.com
mehdisad69@gmail.com
empty
After identification of applicant validity, and getting permission from related organization, the primary outcomes will be sent.
After identification of applicant validity, and getting permission from related organization, the primary outcomes will be sent.
empty
بعد از تأیید هویت فرد درخواست کننده و توافق سازمان مربوطه، یافته های اصلی برای فرد ارسال خواهد شد.
بعد از تأیید هویت فرد درخواست کننده و توافق سازمان مربوطه، یافته های اصلی برای فرد ارسال خواهد شد.
Protocol summary
Study aim
This study aimed to examine the effect of magnesium supplementation on renal function, insulin resistance and metabolic profiles in patients with diabetic nephropathy.
Design
This is a double-blind randomized clinical trial
Settings and conduct
urinary albumin to creatinine ratio (UACR) is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
Participants/Inclusion and exclusion criteria
Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 milligram per deciliter and proteinuria 30-300 milligram per deciliter (micro-albuminuria) and Glomerular Filtration Rate more than 90 milliliter per minute will be chosen.
Intervention groups
Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks.
Main outcome variables
metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201404271485N12
Registration date:2014-05-18, 1393/02/28
Registration timing:prospective
Last update:2018-01-08, 1396/10/18
Update count:1
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Ahmad Esmaillzadeh
Name of organization / entity
Department of Nutrition, School of Public Health, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2791
Email address
esmaillzadeh@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-04-22, 1393/02/02
Expected recruitment end date
2015-04-22, 1394/02/02
Actual recruitment start date
2014-10-06, 1393/07/14
Actual recruitment end date
2016-04-23, 1395/02/04
Trial completion date
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Scientific title
Effect of magnesium supplementation on kidney function, insulin resistance and metabolic profile in patients with diabetic nephropathy
Public title
Effect of magnesium supplementation on improvement of patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than 18 years old
Diabetic nephropathy
Blood glucose more than 126 milligram per decilite
Proteinuria between 30 to 300 milligram per deciliter (micro-albuminuria)
Glomerular Filtration Rate more than 90 milliliter per minute
Not having hypothyroidism and hyperthyroidism; Not having any urine duct infection; Not having any feverish infection; Not using cigarette or other drugs; Not having liver disease; Not having cancer; Not having any inflammatory disease
Not losing weight more than 4 kilogram during last 3 months
Not using any magnesium-rich supplement
Exclusion criteria:
Changing medicine doses
failure to adherence (using less than 75 percent of medicines)
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After stratification for age, sex, type and dose of medication and BMI, subjects were randomly assigned to receive either magnesium supplements or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo was similar in appearance (color, shape, size and packaging) with supplements. Patients were indicated by numbers for principle investigator. Supplement or placebo were handed over the participants by two other health provider not related to the trial.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81745-151
Approval date
2014-04-19, 1393/01/30
Ethics committee reference number
189091
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
N08.3
ICD-10 code description
Diabetic nephropathy
Primary outcomes
1
Description
albumin to creatinine ratio (UACR)
Timepoint
Baseline, week 12
Method of measurement
Commercial kit
Secondary outcomes
1
Description
Blood Urine Nitrogen
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
2
Description
Glomerular Filtration Rate
Timepoint
Baseline, week 12
Method of measurement
commercial kits
3
Description
Proteinuria
Timepoint
Baseline, week 12
Method of measurement
Methyl benzatonium chloride method
4
Description
Fasting Blood Sugar
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
5
Description
Hemoglubin A1c
Timepoint
Baseline, week 12
Method of measurement
High-Performance Liquid Chromatography
6
Description
Serum insulin
Timepoint
Baseline, week 12
Method of measurement
Enzyme-Linked Immunosorbent Assay
7
Description
High Density Lipoprotein
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
8
Description
Low Density Lipoprotein
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
9
Description
Very Low Density Lipoprotein
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
10
Description
Triglyceride
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
11
Description
Total Cholesterol
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
12
Description
C-Reactive Protein
Timepoint
Baseline, week 12
Method of measurement
Enzyme-Linked Immunosorbent Assay
13
Description
creatinine
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
Intervention groups
1
Description
Magnesium supplement, each tablet contains 250 mg magnesium oxide, 1 time a day for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo, similar color, odor and appearance to magnesium supplement, 1 time a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaeilzadeh
Street address
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745-151
Phone
+98 31 3792 3151
Email
a.esmaillzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Payman Adibi
Street address
Research Assistance, Isfahan University of Medical sciences, Av. Hezarjerib, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745-151
Phone
+98 31 3792 3151
Email
a.esmaillzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaeilzade
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745-151
Phone
+98 31 1792 2776
Fax
Email
esmaillzadeh@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic
Full name of responsible person
Ahmad Esmaeilzade
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81745-151
Phone
+98 31 1792 2776
Fax
Email
esmaillzadeh@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
College of Nutrition, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Sadeghian
Position
Bachelor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81745-151
Phone
+31 17922720
Fax
Email
vipmaster1369@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no data sharing agreement from the related organization.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The effect of oral magnesium supplementation on micro-albuminuria and metabolic status of patients with diabetic nephropathy: a double-blind randomized controlled clinical trial
The primary outcome measure only is to be shared
When the data will become available and for how long
January 2017
To whom data/document is available
for people working in academic institutions
Under which criteria data/document could be used
No other criteria are not provided.
From where data/document is obtainable
mehdisad69@gmail.com
What processes are involved for a request to access data/document
After identification of applicant validity, and getting permission from related organization, the primary outcomes will be sent.