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Protocol summary
Objective: The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with diabetic foot. 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 diabetic foot and aged 35 to 75 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 diabetic foot of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 12 weeks. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with diabetic foot. 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 diabetic foot and aged 35 to 75 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 diabetic foot of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 12 weeks. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی 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 زخم پای دیابتی در محدوده سنی 35 تا 75 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 زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 (گروه مداخله:30=n) و 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: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی 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 زخم پای دیابتی در محدوده سنی 35 تا 75 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 زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 (گروه مداخله:30=n) و 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: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with diabetic foot.
The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with diabetic foot.
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هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است.
هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است.
کارآزمایی بالینی تصادفي، دو سوکور ، موازی، 60 نفر، فاز 2
کارآزمایی بالینی تصادفي، دو سوکور ، موازی، 60 نفر، فاز 2
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Sixty patients with diabetic foot of eligible and referred to Infectious Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Sixty patients with diabetic foot of eligible and referred to Infectious Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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شصت بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک عفونی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
شصت بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک عفونی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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Patients with diabetic foot and aged 40 to 85 years will be included in this study. Exclusion criteria is as follows: grade 3 DFU with abscess formation and osteomyelitis, subjects with significant arterial disease, major deformities e.g. Charcot's neuroarthropathy, pregnant and breastfed patients, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids and change in consuming medications throughout the study.
Patients with diabetic foot and aged 40 to 85 years will be included in this study. Exclusion criteria is as follows: grade 3 DFU with abscess formation and osteomyelitis, subjects with significant arterial disease, major deformities e.g. Charcot's neuroarthropathy, pregnant and breastfed patients, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids and change in consuming medications throughout the study.
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بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر است: زخم پای دیابتی درجه 3 با تشکیل آبسه و استئومیلیت ، افراد مبتلا به بیماری شریانی قابل توجه ، ناهنجاریهای عمده به عنوان مثال نوروآرتروپاتی شارکو، بیماران باردار و شیرده ، مصرف مکمل های آنتی اکسیدانی و / یا ضد التهابی مانند ویتامین E ، ویتامین C و اسیدهای چرب امگا 3 و تغییر در مصرف داروها در طول مطالعه.
بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر است: زخم پای دیابتی درجه 3 با تشکیل آبسه و استئومیلیت ، افراد مبتلا به بیماری شریانی قابل توجه ، ناهنجاریهای عمده به عنوان مثال نوروآرتروپاتی شارکو، بیماران باردار و شیرده ، مصرف مکمل های آنتی اکسیدانی و / یا ضد التهابی مانند ویتامین E ، ویتامین C و اسیدهای چرب امگا 3 و تغییر در مصرف داروها در طول مطالعه.
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Patients will be assigned to receive either omega-3 supplements (intervention group: n=30) and placebo (control group: n=30).
Patients will be assigned to receive either omega-3 supplements (intervention group: n=30) and placebo (control group: n=30).
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بیماران برای دریافت مکمل امگا-3 (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
بیماران برای دریافت مکمل امگا-3 (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
Grade 3 DFU with abscess formation and osteomyelitis
Subjects with significant arterial disease
Major deformities e.g. Charcot's neuroarthropathy
Pregnant and breastfed patients
Taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Change in consuming medications throughout the study
Grade 3 DFU with abscess formation and osteomyelitis Subjects with significant arterial disease Major deformities e.g. Charcot's neuroarthropathy Pregnant and breastfed patients Taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids Change in consuming medications throughout the study
زخم پای دیابتیک درجه سه با تشکیل آبسه و پوکی استخوان
افراد مبتلا به بیماری شریانی قابل توجه
ناهنجاریهای عمده به عنوان مثال نوروآرتروپاتی شارکو
بیماران باردار و شیرده
مصرف مکمل های آنتی اکسیدانی و / یا ضد التهابی مانند ویتامین E ، ویتامین C و اسیدهای چرب امگا 3
تغییر در مصرف داروها در طول مطالعه
زخم پای دیابتیک درجه سه با تشکیل آبسه و پوکی استخوان افراد مبتلا به بیماری شریانی قابل توجه ناهنجاریهای عمده به عنوان مثال نوروآرتروپاتی شارکو بیماران باردار و شیرده مصرف مکمل های آنتی اکسیدانی و / یا ضد التهابی مانند ویتامین E ، ویتامین C و اسیدهای چرب امگا 3 تغییر در مصرف داروها در طول مطالعه
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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.
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 امگا-3 (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.
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 امگا-3 (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 infectious clinic affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the infectious clinic affiliated to Kashan University of Medical Sciences, 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 عفونی وابسته به دانشگاه علوم پزشکی کاشان 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.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک عفونی وابسته به دانشگاه علوم پزشکی کاشان 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
Insulin
Insulin resistance
Insulin resistance
انسولین
مقاومت به انسولین
مقاومت به انسولین
Elisa kit
Calculation using HOMA formula
Elisa kitCalculation using HOMA formula
کیت الایزا
محاسبه با استفاده از فرمول HOMA
کیت الایزامحاسبه با استفاده از فرمول HOMA
#2
Insulin resistance
Healing of diabetic foot ulcer
Insulin resistanceHealing of diabetic foot ulcer
مقاومت به انسولین
بهبود زخم پای دیابتی
مقاومت به انسولینبهبود زخم پای دیابتی
Questionnaire
Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
QuestionnaireDecrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
پرسشنامه
کاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر)
پرسشنامهکاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر)
Secondary outcomes
#1
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LDL-cholesterol
LDL-cholesterol
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LDL- کلسترول
LDL- کلسترول
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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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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#2
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Malondialdehyde
Malondialdehyde
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مالون دی آلدئید
مالون دی آلدئید
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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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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#3
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HbA1c
HbA1c
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HbA1c (%)
HbA1c (%)
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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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Biochemical kit
Biochemical kit
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کیت بیوشیمیایی
کیت بیوشیمیایی
#4
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Fasting plasma glucose
Fasting plasma glucose
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گلوکز پلاسمایی ناشتا
گلوکز پلاسمایی 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
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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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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#5
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Insulin
Insulin
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انسولین
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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Elisa kit
Elisa kit
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کیت الایزا
کیت الایزا
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Infectious clinic affiliated to Kashan University of Medical Sciences
Name of recruitment center - Persian: کلینیک عفونی وابسته به دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zahra Soleimani
Full name of responsible person - Persian: زهرا سلیمانی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5554 0026
Fax:
Email: soleimani.zahra@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi ClinicInfectious clinic affiliated to Kashan University of Medical Sciences Name of recruitment center - Persian: کلینیک نقویعفونی وابسته به دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah AsemiZahra Soleimani Full name of responsible person - Persian: ذات اله عاصمیزهرا سلیمانی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5554 0026 Fax: Email: soleimani.zahra@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 کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: 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 5557 8010
Fax:
Email: research@kaums.ac.ir
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 کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: 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 5557 8010 Fax: Email: research@kaums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Vice chancellor for research, Kashan University of Medical Sciences
Kashan University of Medical Sciences
Vice chancellor for research, Kashan University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
دانشگاه علوم پزشکی کاشان
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
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:
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contact.provinces_available:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
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Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Nutritionist
Position - Persian: متخصص 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 5562 0608
Mobile: 098 9133615446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Nutritionist Position - Persian: متخصص 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 5562 0608 Mobile: 098 9133615446 Fax: Email: asemi_z@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: 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:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 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: 8115187159
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: 8115187159 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:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: 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: 8115187159
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: 8115187159 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
undecided
undecided
undecided
undecided
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undecided
undecided
undecided
undecided
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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
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هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with diabetic foot.
Sixty patients with diabetic foot of eligible and referred to Infectious Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with diabetic foot and aged 40 to 85 years will be included in this study. Exclusion criteria is as follows: grade 3 DFU with abscess formation and osteomyelitis, subjects with significant arterial disease, major deformities e.g. Charcot's neuroarthropathy, pregnant and breastfed patients, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids and change in consuming medications throughout the study.
Intervention groups
Patients will be assigned to receive either omega-3 supplements (intervention group: n=30) and placebo (control group: n=30).
Main outcome variables
Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201604025623N72
Registration date:2016-04-15, 1395/01/27
Registration timing:registered_while_recruiting
Last update:2019-09-15, 1398/06/24
Update count:2
Registration date
2016-04-15, 1395/01/27
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of omega-3 supplementation compared with the placebo on metabolic profiles in patients with diabetic foot
Public title
Effect of supplementation in treatment of patients with diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot;
Aged 40 to 85 years
Exclusion criteria:
Grade 3 DFU with abscess formation and osteomyelitis
Subjects with significant arterial disease
Major deformities e.g. Charcot's neuroarthropathy
Pregnant and breastfed patients
Taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Change in consuming medications throughout the study
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 infectious clinic affiliated to Kashan University of Medical Sciences, 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
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.Kaums.REC.1394.173
Health conditions studied
1
Description of health condition studied
Diabetic foot
ICD-10 code
E11 and E1
ICD-10 code description
Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
2
Description
Healing of diabetic foot ulcer
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Biochemical kit
11
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
12
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention