Clinical trial of the effect of low-carbohydrate compared with low-fat diet on metabolic profiles in type 2 diabetes patients with coronary heart disease
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Protocol summary
Objective: The aim of this study is to determine the effects of carbohydrate versus fat restriction on metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD). 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: Invituals aged 45-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 type 2 diabetes patients with CHD 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 carbohydrate restriction (n=30) or fat restriction (n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles. Start and end date of intervention: 8 weeks. Outcomes: Fasting plasma glucose (FPG), serum insulin, lipid profiles and biomarkers of inflammation and oxidative stress will be measured at baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of carbohydrate versus fat restriction on metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD). 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: Invituals aged 45-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 type 2 diabetes patients with CHD 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 carbohydrate restriction (n=30) or fat restriction (n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles. Start and end date of intervention: 8 weeks. Outcomes: Fasting plasma glucose (FPG), serum insulin, lipid profiles and biomarkers of inflammation and oxidative stress will be measured at baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات محدودیت کربوهیدرات در مقابل چربی بر روی پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است. طراحی 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 مطالعه: افراد 75-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی در این مطالعه وارد خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی 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 یا محدودیت کربوهیدرات (30=n) یا محدودیت چربی (30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته. پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، پروفایل های لیپیدی و بیومارکرهای التهاب و استرس اکسیداتیو در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات محدودیت کربوهیدرات در مقابل چربی بر روی پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است. طراحی 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 مطالعه: افراد 75-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی در این مطالعه وارد خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی 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 یا محدودیت کربوهیدرات (30=n) یا محدودیت چربی (30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته. پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، پروفایل های لیپیدی و بیومارکرهای التهاب و استرس اکسیداتیو در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of carbohydrate versus fat restriction on metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
The aim of this study is to determine the effects of carbohydrate versus fat restriction on metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
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هدف این مطالعه تعیین اثرات محدودیت کربوهیدرات در مقابل چربی بر روی پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است.
هدف این مطالعه تعیین اثرات محدودیت کربوهیدرات در مقابل چربی بر روی پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است.
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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.
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.
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طراحی 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.
طراحی 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.
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Population and sample size: 56 type 2 diabetes patients with CHD eligible and referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Population and sample size: 56 type 2 diabetes patients with CHD eligible and referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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حجم نمونه و جمعیت مورد مطالعه: 56 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی واجد شرایط و ارجاع شده به کلینیک قلب و عروق وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 56 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی واجد شرایط و ارجاع شده به کلینیک قلب و عروق وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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Inclusion Criteria: Overweight patients aged 40-85 years old and diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Consuming antiobesity medications within the last 3 months, having an acute myocardial infarction and cardiac surgery within the last 3 months, renal or liver failure.
Inclusion Criteria: Overweight patients aged 40-85 years old and diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Consuming antiobesity medications within the last 3 months, having an acute myocardial infarction and cardiac surgery within the last 3 months, renal or liver failure.
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معیارهای ورود به مطالعه: بیماران دارای اضافه وزن در سن 40-85 سال و تشخیص ابتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیارهای خروج مطالعه: مصرف داروهای ضدچاقی در 3 ماه گذشته، داشتن انفارکتوس حاد میوکارد و جراحی قلب در 3 ماه گذشته، نارسایی کلیوی و کبدی.
معیارهای ورود به مطالعه: بیماران دارای اضافه وزن در سن 40-85 سال و تشخیص ابتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیارهای خروج مطالعه: مصرف داروهای ضدچاقی در 3 ماه گذشته، داشتن انفارکتوس حاد میوکارد و جراحی قلب در 3 ماه گذشته، نارسایی کلیوی و کبدی.
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Intervention: Patients will be assigned to receive either carbohydrate restriction (n=28) or fat restriction (n=28). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles. Start and end date of intervention: 8 weeks.
Intervention: Patients will be assigned to receive either carbohydrate restriction (n=28) or fat restriction (n=28). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles. Start and end date of intervention: 8 weeks.
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مداخله مورد مطالعه: بیماران برای دریافت یا محدودیت کربوهیدرات (28=n) یا محدودیت چربی (28=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
مداخله مورد مطالعه: بیماران برای دریافت یا محدودیت کربوهیدرات (28=n) یا محدودیت چربی (28=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
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Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
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پيامدها: بیومارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی و متابولیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: بیومارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی و متابولیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
Overweight patients aged 40-85 years old
Diagnosed with type 2 diabetes and coronary heart disease
Overweight patients aged 40-85 years old Diagnosed with type 2 diabetes and coronary heart disease
بیماران دارای اضافه وزن در سن 40-85 سال
تشخیص ابتلا به بیماری دیابت تیپ 2 و کرونر قلبی
بیماران دارای اضافه وزن در سن 40-85 سال تشخیص ابتلا به بیماری دیابت تیپ 2 و کرونر قلبی
Consuming antiobesity medications within the last 3 months
Having an acute myocardial infarction and cardiac surgery within the last 3 months
Renal or liver failure
Consuming antiobesity medications within the last 3 months Having an acute myocardial infarction and cardiac surgery within the last 3 months Renal or liver failure
مصرف داروهای ضدچاقی در 3 ماه گذشته
داشتن انفارکتوس حاد میوکارد و جراحی قلب در 3 ماه گذشته
نارسایی کلیوی و کبدی
مصرف داروهای ضدچاقی در 3 ماه گذشته داشتن انفارکتوس حاد میوکارد و جراحی قلب در 3 ماه گذشته نارسایی کلیوی و کبدی
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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 receive either carbohydrate restriction (n = 28) or fat restriction (n = 28). 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 receive either carbohydrate restriction (n = 28) or fat restriction (n = 28). 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 دریافت یا محدودیت کربوهیدرات (n = 28) و محدودیت چربی (n = 28) 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 دریافت یا محدودیت کربوهیدرات (n = 28) و محدودیت چربی (n = 28) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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Primary outcomes
#1
Questionnaire
Elisa kit
QuestionnaireElisa kit
پرسشنامه
کیت الایزا
پرسشنامهکیت الایزا
Secondary outcomes
#1
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Nitric oxide
Nitric oxide
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نیتریک اکساید
نیتریک اکساید
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At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#2
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VLDL
VLDL
empty
VLDL
VLDL
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#3
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LDL
LDL
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LDL
LDL
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#4
empty
FPG
FPG
empty
قند خون ناشتا
قند خون ناشتا
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#5
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Malondialdehyde
Malondialdehyde
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مالون دی آلدئید
مالون دی آلدئید
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
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در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
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: Ghotbe Ravandi Boulevard, 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: Cardiology Clinic
Name of recruitment center - Persian: کلینیک قلب و عروق
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: NaghaviCardiology Clinic Name of recruitment center - Persian: کلینیک نقویقلب و عروق Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com 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:
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: 8115187159
Phone: +98 31 5546 3378
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: 8115187159 Phone: +98 31 5546 3378 Fax: Email: research@kaums.ac.ir Web page address:
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public
empty
Domestic
domestic
empty
Academic
academic
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:
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City - English:
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contact.provinces_available:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
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: Nutrition PhD
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: Name of organization / entity - Persian: Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Nutrition PhD 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:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 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:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 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
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available.
Undecided - It is not yet known if there will be a plan to make this available.
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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 carbohydrate versus fat restriction on metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
Design
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.
Settings and conduct
Population and sample size: 56 type 2 diabetes patients with CHD eligible and referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Overweight patients aged 40-85 years old and diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Consuming antiobesity medications within the last 3 months, having an acute myocardial infarction and cardiac surgery within the last 3 months, renal or liver failure.
Intervention groups
Intervention: Patients will be assigned to receive either carbohydrate restriction (n=28) or fat restriction (n=28). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles. Start and end date of intervention: 8 weeks.
Main outcome variables
Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
Reason for update
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number:IRCT201601025623N61
Registration date:2016-01-09, 1394/10/19
Registration timing:retrospective
Last update:2019-11-10, 1398/08/19
Update count:1
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of low-carbohydrate compared with low-fat diet on metabolic profiles in type 2 diabetes patients with coronary heart disease
Public title
Effect of diet therapy in treatment of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight patients aged 40-85 years old
Diagnosed with type 2 diabetes and coronary heart disease
Exclusion criteria:
Consuming antiobesity medications within the last 3 months
Having an acute myocardial infarction and cardiac surgery within the last 3 months
Renal or liver failure
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
56
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 receive either carbohydrate restriction (n = 28) or fat restriction (n = 28). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
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
81151-87159
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.Kaums.REC.1394.96
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Ischaemic heart disease (chronic) NOS
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
hs-CRP
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Total antioxidant
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
VLDL
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
LDL
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
FPG
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
11
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Carbohydrates restriction group: 43-47% carbohydrates, 36-40% fats, for 8 weeks.
Category
Other
2
Description
Fats restriction group: 60-65% carbohydrates, 20-25% fats, for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiology Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
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
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
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