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The effects of selenium supplementation on advanced glycation end products, biomarkers of inflammatory and oxidative stress in diabetic nephropathy patients in comparison with placebo: a randomized double-blinded controlled clinical trial

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History
# Registration date Revision Id
2 2019-09-02, 1398/06/11 103572
1 2015-08-02, 1394/05/11 19434
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of selenium supplementation on advanced glycation end products (AGEs), inflammatory factor and biomarkers of oxidative stress in diabetic nephropathy patients. Study design: Randomized double-blinded controlled clinical trial. Blinding is carried out for patients and researchers and randomization in done by random table numbers. Inclusion Criteria: Patients with diabetic nephropathy aged 35 to 75 years will be included in this study. The use of substitute treatments including hormone or vitamin supplements, patients with liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune), pregnant or lactating women will be included in this study. Exclusion Criteria: Patients who do not want to cooperate؛ diabetic patients who have others complications associated with diabetes are excluded from this study. Population and sample size: 60 patients with diabetic nephropathy who are eligible and are referred to kidney sections of Beheshti hospital and Akhavan dialysis center affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Intervention: Patients will be assigned to receive either selenium (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Intervention duration is 12 weeks. Outcomes: serum levels of glutathione peroxidase, an advanced glycation end products (AGE), inflammatory factors such as matrix metalloproteinase 2 (MMP2) and TGF_beta and malondialdehyde (MDA) oxidative stress factor will be measured.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری سلنيوم بر روي محصولات گلیکاسیون پیشرفته(AGE) ، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران نفروپاتی دیابتی است. طراحي انجام مطالعه: کارآزمایی بالینی تصادفي دو سوكور موازي. كورسازي براي بيماران و پژوهشگران صورت گرفت و تصادفي سازي از طريق جدول اعداد تصادفي انجام شد. معیارهای ورود به مطالعه: افراد 75-35 ساله؛ مبتلا به بیماری دیابت تیپ 2 همراه با نفروپاتي، استفاده كنندگان از درمان هاي جايگزين مانند هورمون ها و مكمل هاي ويتاميني، افراد مبتلا به بيماري كبدي، ريوي و بيماري های مزمن يا حاد التهابي، بیماری دریچه قلب، سندروم روده کوتاه و آلرژی، افراد با نقص سیستم ایمنی (اتوایمیون)، زنان باردار و شیرده. معیارهای خروج از مطالعه: بیمارانی که تمایل به همکاری نداشته باشند؛ بیماران دیابتی که عوارض دیگر مرتبط با دیابت را داشته باشند از اين مطالعه خارج شدند. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به نفروپاتی دیابتیک واجد شرایط و ارجاع شده به بخش کلیه بیمارستان شهید بهشتی و مرکز دیالیز اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا سلنيوم (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: سطح سرمی گلوتاتيون پراكسيداز، محصولات نهایی گلیکاسیون پیشرفته (AGE)، فاکتورهای التهابی ماتریکس متالو پروتئاز2(MMP2) ، TGF_beta و همچنین فاکتور استرس اکسیداتیو مالون دی آلدهید (MDA) اندازه گیری خواهد شد.
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    The aim of this study is to determine the effects of selenium supplementation on advanced glycation end products (AGEs), inflammatory factor and biomarkers of oxidative stress in diabetic nephropathy patients.
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    هدف این مطالعه تعیین اثرات مکمل یاری سلنيوم بر روي محصولات گلیکاسیون پیشرفته(AGE) ، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران نفروپاتی دیابتی است.
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    Randomized double-blinded controlled clinical trial. Blinding is carried out for patients and researchers and randomization in done by random table numbers. Patients will be assigned to receive either selenium (intervention group: n=30) or placebo (control group: n=30).
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    کارآزمایی بالینی تصادفي دو سوكور موازي. كورسازي براي بيماران و پژوهشگران صورت گرفت و تصادفي سازي از طريق جدول اعداد تصادفي انجام شد. بیماران برای دریافت یا سلنيوم (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Among patients with diabetic nephropathy referred to the Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention.
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    از بین بیماران نفروپاتی دیابتی ارجاع شده به کلینیک شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد.
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    Patients with diabetic nephropathy aged 40 to 85 years will be included in this study. Inclusion Criteria: Patients with diabetic nephropathy with a proteinuria level of >0.3 g/24 hours, with or without circulating levels of serum creatinine. Exclusion criteria: The consuming selenium supplements within 3 months before beginning of the study, history of hospital admission within 3 months, bacteriuria, haematuria, urinary tract infection, patients with uncontrolled diabetes, pregnant women and those with liver or inflammatory diseases.
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    بیماران مبتلا به نفروپاتی دیابتی 40 تا 85 سال در این مطالعه وارد خواهند شد. معیارهای ورود به مطالعه: بیماران مبتلا به نفروپاتی دیابتی با سطح پروتئینوری> 0.3 گرم در 24 ساعت ، با یا بدون سطح گردش خون کراتینین سرم. معیارهای خروج از مطالعه: مصرف مکمل های سلنیوم در مدت 3 ماه قبل از شروع مطالعه ، سابقه بستری در بیمارستان در مدت 3 ماه ، باکتریوری ، هماچوری ، عفونت مجاری ادراری ، بیماران مبتلا به دیابت کنترل نشده ، زنان باردار و مبتلایان به بیماریهای کبدی یا التهابی.
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    Patients will be assigned to receive either selenium (intervention group: n=30) or placebo (control group: n=30).
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    بیماران برای دریافت یا سلنيوم (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Outcomes: Markers of insulin, insulin resistance and high-sensitivity C-reactive Protein (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
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    پيامدها: انسولین، مقاومت به انسولین و پروتئین واکنشگر C با حساسیت بالا (پیامدهای اولیه) و سایر پروفایل های متابولیک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    35
    40
    75
    85
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    1
    Diabetic nephropathy with a proteinuria level of >0.3 g/24 hours
    With or without circulating levels of serum creatinine
    نفروپاتی دیابتی با سطح پروتئینوری> 0.3 گرم در 24 ساعت
    با یا بدون سطح گردش خون کراتینین سرم
    The consumption of selenium supplements within 3 months before beginning of the study
    Patients with uncontrolled diabetes
    Pregnant women
    Liver diseases
    Inflammatory diseases
    Bacteriuria
    Haematuria
    Urinary tract infection
    History of hospital admission within 3 months
    مصرف مکمل سلنیوم در سه ماه قبل از آغاز مطالعه
    بیماران مبتلا به دیابت کنترل نشده
    زنان باردار
    بیماری های کبدی
    بیماری های التهابی
    باکتریوری
    هماچوری
    عفونت مجاری ادراری
    سابقه بستری در بیمارستان در سه ماه گذشته
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    At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either selenium supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل سلنیوم (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد 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 Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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 شهید بهشتی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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  • Primary outcomes

    #1
    Matrix metalloproteinases 2 (MMP2)
    serum insulin
    ماتریکس متالوپروتئاز 2 (MMP-2)
    انسولين سرم
    In serum sample will assessed by ELISA kit. ng/ml
    In serum sample will assessed by ELISA kit. mU/ml
    انجام ازمایش بر روی سرم به روش الایزا برحسب نانوگرم بر میلی لیتر
    انجام ازمایش بر روی سرم به روش الایزا برحسب ميكرو واحد بين المللي بر میلی لیتر
    #2
    Protein carbonyl
    Inflammatory factor hs-CRP
    پروتئین کربونیل
    فاكتور التهابي hs-CRP
    قبل و بعد از سه ماه مداخله
    قبل و سه ماه بعد از مداخله
    In serum sample will assessed by cholorimetric method
    In serum sample will assessed by ELISA kit. ng/ml
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب نانو مول بر گرم پروتئين
    انجام ازمایش بر روی سرم به روش الایزا برحسب نانوگرم بر میلی لیتر
    #3
    Tumor growth factor-beta (TGF-b)
    Insulin resistance
    فاکتور نكروز دهنده تومور-بتا
    مقاومت به انسولین
    قبل و بعد از سه ماه مداخله
    قبل و سه ماه بعد از مداخله
    In serum sample will assessed.by an enzyme-linking immunosorbent assay (ELISA) kit. pg/ml
    Calculation using HOMA formula
    انجام ازمایش بر روی سرم به روش الایزا برحسب پیکو گرم بر میلی لیتر
    محاسبه با استفاده از فرمول HOMA
    #4
    Gluthatione peroxidase (GPx)
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    گلوتاتيون پراكسيداز
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    Before and three months after intervention
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    قبل و سه ماه بعد از مداخله
    empty
    In serum sample will assessed.by an enzyme-linking immunosorbent assay (ELISA) kit. U/gHb
    empty
    انجام ازمایش بر روی سرم به روش الایزا برحسب واحد بر گرم هموگلوبين
    empty
    #5
    Malondialdehyde (MAD)
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    مالون دی آلدهید
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed.by spectrophotometric method.µmol/L
    empty
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب میکرو مول بر لیتر
    empty
    #6
    advanced glycation end products (AGEs)
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    محصولات نهایی گلیکاسیون پیشرفته
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    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed by fluorescence method
    empty
    انجام ازمایش بر روی سرم ها به روش فلوریمتری
    empty
    #7
    Total Gluthatione
    empty
    گلوتاتيون توتال
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed.by spectrophotometric method.µmol/L
    empty
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب میکرو مول بر لیتر
    empty
    #8
    plasma total antioxidant
    empty
    آنتی اکسیدان تام پلاسمایی
    empty
    Before and three months after intervention
    empty
    قبل و سه ماه بعد از مداخله
    empty
    In serum sample will assessed by cholorimetric method
    empty
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب میلي مول بر لیتر
    empty
    #9
    serum insulin
    empty
    انسولين سرم
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed by ELISA kit. mU/ml
    empty
    انجام ازمایش بر روی سرم به روش الایزا برحسب ميكرو واحد بين المللي بر میلی لیتر
    empty
    #10
    Inflammatory factor hs-CRP
    empty
    فاكتور التهابي hs-CRP
    empty
    Before and three months after intervention
    empty
    قبل و سه ماه بعد از مداخله
    empty
    In serum sample will assessed by ELISA kit. ng/ml
    empty
    انجام ازمایش بر روی سرم به روش الایزا برحسب نانوگرم بر میلی لیتر
    empty

  • Secondary outcomes

    #1
    empty
    Matrix metalloproteinases 2 (MMP2)
    empty
    ماتریکس متالوپروتئاز 2 (MMP-2)
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed by ELISA kit. ng/ml
    empty
    انجام ازمایش بر روی سرم به روش الایزا برحسب نانوگرم بر میلی لیتر
    #2
    empty
    Protein carbonyl
    empty
    پروتئین کربونیل
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed by cholorimetric method
    empty
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب نانو مول بر گرم پروتئين
    #3
    empty
    Tumor growth factor-beta (TGF-b)
    empty
    فاکتور نكروز دهنده تومور-بتا
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed.by an enzyme-linking immunosorbent
    empty
    انجام ازمایش بر روی سرم به روش الایزا برحسب پیکو گرم بر میلی لیتر
    #4
    empty
    Gluthatione peroxidase (GPx)
    empty
    گلوتاتيون پراكسيداز
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed.by an enzyme-linking immunosorbent
    empty
    انجام ازمایش بر روی سرم به روش الایزا برحسب واحد بر گرم هموگلوبين
    #5
    empty
    Malondialdehyde (MAD)
    empty
    مالون دی آلدهید
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed.by spectrophotometric method.µmol/L
    empty
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب میکرو مول بر لیتر
    #6
    empty
    Advanced glycation end products (AGEs)
    empty
    محصولات نهایی گلیکاسیون پیشرفته
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed by fluorescence method
    empty
    انجام ازمایش بر روی سرم ها به روش فلوریمتری
    #7
    empty
    Total Gluthatione
    empty
    گلوتاتيون توتال
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed.by spectrophotometric method.µmol
    empty
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب میکرو مول بر لیتر
    #8
    empty
    Plasma total antioxidant
    empty
    آنتی اکسیدان تام پلاسمایی
    empty
    Before and three months after intervention
    empty
    قبل و بعد از سه ماه مداخله
    empty
    In serum sample will assessed by cholorimetric method
    empty
    انجام ازمایش بر روی سرم به روش رنگ سنجی برحسب میلي مول بر لیتر

  • Recruitment centers

    #1
    Name of recruitment center - English: Kidney Sections of Beheshti Hospital
    Name of recruitment center - Persian: بخش کلیه بیمارستان شهید بهشتی
    Full name of responsible person - English: Dr.Alireza Soleimani
    Full name of responsible person - Persian: دکتر علیرضا سلیمانی
    Street address - English:
    Street address - Persian:
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Kidney Sections of Beheshti Hospital
    Name of recruitment center - Persian: بخش کلیه بیمارستان شهید بهشتی
    Full name of responsible person - English: Dr.Alireza Soleimani
    Full name of responsible person - Persian: دکتر علیرضا سلیمانی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: soleimani_a@kaums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Dialysis Department of Akhavan Hospital
    Name of recruitment center - Persian: بخش دیالیز بیمارستان اخوان
    Full name of responsible person - English:
    Full name of responsible person - Persian: دکتر علیرضا سلیمانی
    Street address - English:
    Street address - Persian:
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Dialysis Department of Akhavan Hospital
    Name of recruitment center - Persian: بخش دیالیز بیمارستان اخوان
    Full name of responsible person - English: Dr.Alireza Soleimani
    Full name of responsible person - Persian: دکتر علیرضا سلیمانی
    Street address - English: Abazar Street
    Street address - Persian: خیابان اباذر
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5544 6023
    Fax:
    Email: soleimani_a@kaums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی كاشان
    Full name of responsible person - English: Dr.Gholam Ali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، معاونت پژوهشی دانشگاه
    City - English: Kashan
    City - Persian: كاشان
    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, Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی كاشان
    Full name of responsible person - English: Dr.Gholam Ali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، معاونت پژوهشی دانشگاه
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 2999
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr. Fereshteh Bahmani
    Full name of responsible person - Persian: دكتر فرشته بهمني
    Position - English: PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
    Position - Persian: PhD بیوشیمی بالینی/ هیات علمی گروه بیوشیمی بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Medical Faculty,Kashan University of Medical Sciences,Ravand road
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5554 0021
    Mobile: 00
    Fax:
    Email: bahmani@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: Dr. Fereshteh Bahmani
    Full name of responsible person - Persian: دكتر فرشته بهمني
    Position - English: PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
    Position - Persian: PhD بیوشیمی بالینی/ هیات علمی گروه بیوشیمی بالینی
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Medical Faculty,Kashan University of Medical Sciences,Ravand road
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 0021
    Mobile: +98 912 423 7542
    Fax:
    Email: bahmani@kaums.ac.ir
    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: Dr. Fereshteh Bahmani
    Full name of responsible person - Persian: دكتر فرشته بهمني
    Position - English: PhD of Clinical Biochemistry
    Position - Persian: ph.D بیوشیمی بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Medical Faculty, Kashan University of Medical Sciences, Ravand road
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5554 0021
    Mobile: 00
    Fax:
    Email: bahmani@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: Dr. Fereshteh Bahmani
    Full name of responsible person - Persian: دكتر فرشته بهمني
    Position - English: PhD of Clinical Biochemistry
    Position - Persian: ph.D بیوشیمی بالینی
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Medical Faculty, Kashan University of Medical Sciences, Ravand road
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 0021
    Mobile: +98 912 423 7542
    Fax:
    Email: bahmani@kaums.ac.ir
    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: Dr. Fereshteh Bahmani
    Full name of responsible person - Persian: دكتر فرشته بهمني
    Position - English: PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
    Position - Persian: PhD بیوشیمی بالینی/ هیات علمی گروه بیوشیمی بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Medical faculty, Kashan University of medical Sciences, Ravand road, Kashan,Iran
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5554 0021
    Mobile: 00
    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: Dr. Fereshteh Bahmani
    Full name of responsible person - Persian: دكتر فرشته بهمني
    Position - English: PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
    Position - Persian: PhD بیوشیمی بالینی/ هیات علمی گروه بیوشیمی بالینی
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Medical faculty, Kashan University of medical Sciences, Ravand road, Kashan,Iran
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 0021
    Mobile: +98 912 423 7542
    Fax:
    Email: bahmani@kaums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Undecided - It is not yet known if there will be a plan to make this available
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
The aim of this study is to determine the effects of selenium supplementation on advanced glycation end products (AGEs), inflammatory factor and biomarkers of oxidative stress in diabetic nephropathy patients.
Design
Randomized double-blinded controlled clinical trial. Blinding is carried out for patients and researchers and randomization in done by random table numbers. Patients will be assigned to receive either selenium (intervention group: n=30) or placebo (control group: n=30).
Settings and conduct
Among patients with diabetic nephropathy referred to the Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Patients with diabetic nephropathy aged 40 to 85 years will be included in this study. Inclusion Criteria: Patients with diabetic nephropathy with a proteinuria level of >0.3 g/24 hours, with or without circulating levels of serum creatinine. Exclusion criteria: The consuming selenium supplements within 3 months before beginning of the study, history of hospital admission within 3 months, bacteriuria, haematuria, urinary tract infection, patients with uncontrolled diabetes, pregnant women and those with liver or inflammatory diseases.
Intervention groups
Patients will be assigned to receive either selenium (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Outcomes: Markers of insulin, insulin resistance and high-sensitivity C-reactive Protein (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2015060622562N1
Registration date: 2015-08-02, 1394/05/11
Registration timing: registered_while_recruiting

Last update: 2019-09-15, 1398/06/24
Update count: 1
Registration date
2015-08-02, 1394/05/11
Registrant information
Name
Fereshteh Bahmani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
fbahmani@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-07-11, 1394/04/20
Expected recruitment end date
2015-08-11, 1394/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of selenium supplementation on advanced glycation end products, biomarkers of inflammatory and oxidative stress in diabetic nephropathy patients in comparison with placebo: a randomized double-blinded controlled clinical trial
Public title
The effect of selenium on nephropathy complications of diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic nephropathy with a proteinuria level of >0.3 g/24 hours With or without circulating levels of serum creatinine
Exclusion criteria:
The consumption of selenium supplements within 3 months before beginning of the study Patients with uncontrolled diabetes Pregnant women Liver diseases Inflammatory diseases Bacteriuria Haematuria Urinary tract infection History of hospital admission within 3 months
Age
From 40 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either selenium supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random 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 Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan university of medical sciences and health services
Street address
kashan university of medical sciences and health services, Ravand road
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.KAUMS.REC.1394.22

Health conditions studied

1

Description of health condition studied
diabetic nephropathy
ICD-10 code
E11.2
ICD-10 code description
non-insulin-dependent diabetes mellitus with renal complications

Primary outcomes

1

Description
serum insulin
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by ELISA kit. mU/ml

2

Description
Inflammatory factor hs-CRP
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by ELISA kit. ng/ml

3

Description
Insulin resistance
Timepoint
Before and three months after intervention
Method of measurement
Calculation using HOMA formula

Secondary outcomes

1

Description
Matrix metalloproteinases 2 (MMP2)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by ELISA kit. ng/ml

2

Description
Protein carbonyl
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by cholorimetric method

3

Description
Tumor growth factor-beta (TGF-b)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by an enzyme-linking immunosorbent

4

Description
Gluthatione peroxidase (GPx)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by an enzyme-linking immunosorbent

5

Description
Malondialdehyde (MAD)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by spectrophotometric method.µmol/L

6

Description
Advanced glycation end products (AGEs)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by fluorescence method

7

Description
Total Gluthatione
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by spectrophotometric method.µmol

8

Description
Plasma total antioxidant
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by cholorimetric method

Intervention groups

1

Description
Intervention: received one capsule of 200 μg selenium, daily for three months
Category
Treatment - Other

2

Description
control: received one capsule of placebo daily for three months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kidney Sections of Beheshti Hospital
Full name of responsible person
Dr.Alireza Soleimani
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
soleimani_a@kaums.ac.ir

2

Recruitment center
Name of recruitment center
Dialysis Department of Akhavan Hospital
Full name of responsible person
Dr.Alireza Soleimani
Street address
Abazar Street
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5544 6023
Email
soleimani_a@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr.Gholam Ali Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Fax
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Bahmani
Position
PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Medical Faculty,Kashan University of Medical Sciences,Ravand road
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Fax
Email
bahmani@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Bahmani
Position
PhD of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Fax
Email
bahmani@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
Dr. Fereshteh Bahmani
Position
PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Medical faculty, Kashan University of medical Sciences, Ravand road, Kashan,Iran
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Fax
Email
bahmani@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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