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Effect of differential exercise training on endothelial function of type 2 diabetes and relation with inflammatory cytokines

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History
# Registration date Revision Id
2 2018-01-17, 1396/10/27 36136
1 2016-03-04, 1394/12/14 19737
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  • Protocol summary

    The purpose of this study will be investigation of weight bearing interval training and non-weight bearing interval training on endothelial function of type 2 diabetes and relation with effective mechanisms in improvement endothelial function. The study design will be base on double blind. seventy patient will be equally divided and randomized into four groups including high intensity interval training on treadmill, high intensity interval training on ergometer, high intensity interval training combination of treadmill and ergometer.Including criteria: included having a history of type 2 diabetes more than two years, glycosylated hemoglobin <6% (HbA1C <6%), body mass index over 25, hypertension uncontrolled pre or I stage, no history of 6 months of regular exercise (more than one day a week) to do the study. Exclusion criteria included fasting blood glucose over 400 mg / dl, functional limitations (such as osteoarthritis), liver or kidney failure, history of myocardial infarction or coronary artery bypass surgery or angioplasty, chronic heart failure, arrhythmias, HbA1C > 10%. Protocol of treadmill 6*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax), ergometer 6*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax) and combination protocol 3*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax) on treadmill and 3*(4 minutes at 85-90 % HRmax and 3 minutes active interval at 55-60% HRmax) on ergometer will be undertaken for 12weeks. Indicators of FMD, NOx, ET-1, apelin, arterial stiffness and inflamatory cytokines will be measured before and after the 12 week training program.
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    در این مطالعه، هدف بررسی تاثیر تمرینات تناوبی متحمل وزن و غیر متحمل وزن بر عملکرد اندوتلیال عروقی بیماران دیابت نوع -2 و ارتباط آن با سازوکارهای موثر در بهبود عملکرد اندوتلیالی خواهد بود. مطالعه بر اساس دو سویه کور طراحی خواهد شد. نحوه انجام: 70 بیمار به صورت یکسان و تصادفی شده به چهار گروه تمرین تناوبی با شدت بالا روی دوچرخه، تمرین تناوبی با شدت بالا روی تریدمیل، تمرین تناوبی با شدت بالا ترکیبی دوچرخه و تریدمیل و گروه کنترل تقسیم خواهند شد. شرایط ورود به مطالعه: شامل دارا بودن سابقه بیماری دیابت نوع 2 بیش از 2 سال، هموگلوبین گلیکوزیله بیش از 6 درصد (HbA1C<6%)، شاخص توده بدنی بیش از 25، پرفشارخونی کنترل نشده pre یا I stage، نداشتن سابقه 6 ماه فعالیت ورزشی منظم (بیش از یک روز در هفته) قبل از انجام مطالعه خواهد بود. شرایط خروج از مطالعه: شامل گلوکز خون ناشتاس بیش از 400 mg/dl، محدودیت های عملکردی (نظیر استئوآرتریت)، نارسایی کبدی و کلیوی، داشتن سابقه انفارکتوس میوکارد یا جراحی بای پس عروق کرونر یا آنژیوپلاستی، نارسایی قلبی مزمن، آریتمی، HbA1C بالای 10 درصد خواهد بود. پروتکل های تمرین تناوبی در گروه تریدمیل و دوچرخه 6 * (4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه با 3 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه)، گروه ترکیبی شامل 3 * (4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه با 3 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه) روی تریدمیل و 3 * (4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه با 3 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه) روی دوچرخه به مدت 12 هفته خواهد بود. شاخص های FMD، نیترات/نیتریت، اندوتلین-1، اپلین، سفتی عروق و سیتوکین های التهابی قبل و بعد از 12 هفته اندازه گیری خواهد شد.
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    Investigation of low-volume high- intensity interval training, high- volume high- intensity interval training and continuous intensity moderate training on endothelial function of type 2 diabetes and relation with mechanisms involved in endothelial function.
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    بررسی مقایسه تمرینات تناوبی با شدت بالا کم حجم، تمرینات تناوبی با شدت بالا با حجم بالا و تمرین تداومی با شدت متوسط بر عملکرد اندوتلیال عروقی بیماران دیابت نوع -2 و ارتباط آن با سازوکارهای درگیر در عملکرد اندوتلیالی
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    In this study, 70 participants divided into 4 groups low-volume high- intensity interval training, high- volume high- intensity interval training, continuous intensity moderate training and control. Randomization was performed by block randomization with a block size of 4. Randomised clinical trial with single-blind and parallel groups.
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    در این مطالعه 70 شرکت کننده به 4 گروه تمرین تناوبی با شدت بالا کم حجم، تمرین تناوبی با شدت بالا با حجم بالا، تمرین تداومی با شدت متوسط و گروه کنترل تقسیم شدند. نمونه ها با روش تصادفی سازی بلوک اندازه 4 تصادفی شدند. کارآزمایی بالینی دارای گروه کنترل با گروه های موازی یک سویه کور تصادفی شده است.
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    This study was performed in physical education of University of Tehran and Metabolism and Diabetes Center of Shariati hospital. Participants, outcome assessor and statistic specialist was blinded. They did not know which group they were in because they were assigned in groups based on randomization and the codes they provided. The specialists of assessment and statistical analysis were unaware of the study because the groups were sent to him based on coding.
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    این مطالعه در دانشکده تربیت بدنی دانشگاه تهران و مرکز متابولیسم و دیابت بیمارستان شریعتی انجام خواهد شد. شرکت کننده ها، متخصصین ارزیابی و متخصص امار در این مطالعه کور سازی شده بودند. متخصصین ارزیابی نسبت به گروه های مطالعه جهت ارزیابی متغییرها آگاهی نداشتند زیرا برای هر آزمودنی کد مخصوصی وجود داشت.
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    Including criteria: included having a history of type 2 diabetes more than two years, glycosylated hemoglobin <6% (HbA1C <6%), body mass index over 25, hypertension uncontrolled pre or I stage, no history of 6 months of regular exercise (more than one day a week) to do the study. Exclusion criteria included fasting blood glucose over 400 mg/dl, functional limitations (such as osteoarthritis), liver or kidney failure, history of myocardial infarction or coronary artery bypass surgery or angioplasty, chronic heart failure, cardiac arrhythmias, smoking, insulin therapy and HbA1C > 10%.
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    شرایط ورود به مطالعه: شامل دارا بودن سابقه بیماری دیابت نوع 2 بیش از 2 سال، هموگلوبین گلیکوزیله بیش از 6 درصد (HbA1C<6%)، شاخص توده بدنی بیش از 25، پرفشارخونی کنترل نشده pre یا I stage، نداشتن سابقه 6 ماه فعالیت ورزشی منظم (بیش از یک روز در هفته) قبل از انجام مطالعه خواهد بود. شرایط خروج از مطالعه: شامل گلوکز خون ناشتاس بیش از 400 mg/dl، محدودیت های عملکردی (نظیر استئوآرتریت)، نارسایی کبدی و کلیوی، داشتن سابقه انفارکتوس میوکارد یا جراحی بای پس عروق کرونر یا آنژیوپلاستی، نارسایی قلبی مزمن، آریتمی قلبی، استعمال سیگار، انسولین درمانی، HbA1C بالای 10 درصد خواهد بود.
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    1. High- volume high- intensity interval training that program was including 6 intervals 4 minutes at 85-90% HRmax that separated by 3 minutes active period at 45- 50% HRmax. 2. Low- volume high- intensity interval training that program was including 12 intervals 1.5 minutes at 85-90% HRmax that separated by 2 minutes active period at 55- 60% HRmax. 3. Continues moderate intensity training consist of 42 minutes at 70% HRmax. 4. Control group that maintenance daily activities and no have regular exercise.
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    1. تمرین تناوبی با شدت بالا با حجم بالا که برنامه تمرینی آن ها شامل 6 تناوب 4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه که بود که هر تناوب با 3 دقیقه تناوب فعال با شدت 45- 50 درصد ضربان قلب بیشینه جدا خواهد شد. 2. تمرین تناوبی با شدت بالا کم حجم که برنامه تمرینی آن ها شامل 12 تناوب 1.5 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه که بود که هر تناوب با 2 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه جدا خواهد شد. 3. تمرین تداومی با شدت متوسط که شامل 42 دقیقه با شدت 70 درصد ضربان قلب بیشینه خواهد بود. 4. گروه کنترل که فعالیت روزانه خود را انجام می دادند و به جز ان هیچ گونه فعالیت ورزشی نداشتند.
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    Flow-mediated dilation; Diameter at baseline; Diameter at peak; Antegrade shear rate؛ Retrograde shear rate؛ Oscillatory shear index؛ Nitrite/ Nitrate; Endothelin-1; Apelin; Arterial stiffness; Superoxide dismutase; Malondialdehyde; Carotid intima-media thickness; Resistance insulin; Lipid profile; VO2peak; exercise time; Resting and maximal heart rate; Resting diastolic blood pressure; Resting systolic blood pressure
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    اتساع ناشی از جریان خون؛ قطر رگ در حالت استراحت؛ قطر رگ در اوج رگ گشایی؛ Antegrade shear rate؛ Retrograde shear rate؛ Oscillatory shear index؛ نیترات/نیتریت؛ اندوتلین-1؛ اپلین؛ سفتی عروق؛ سوپراکسید دیسموتاز؛ مالون دی آلدئید، ضخامت لایه میانی- داخلی کاروتید، مقاومت به انسولین، نیمرخ لیپیدی، گلوکز ناشتا، حداکثر اکسیژن مصرفی، زمان تست ورزشی؛ ضربان قلب استراحت و بیشینه؛ فشار خون دیاستول در استراحت، فشار خون سیستول در استراحت

  • General information

    Double blinded
    Single blinded
    1
    1
    1
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    70
    2015-12-21, 1394/09/30
    2016-03-20, 1395/01/01
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    2015-05-05, 1394/02/15
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    2016-04-24, 1395/02/05
    History of type 2 diabetes more than 2 years
    No history of 6 months of regular exercise
    Glycosylated hemoglobin <6%(HbA1C <6%)
    Body mass index over 25
    Hypertension uncontrolled pre or I stage
    ابتلا به دیابت نوع 2 بیش از 2 سال
    نداشتن 6 ماه سابقه فعالیت ورزشی منظم
    هموگلوبین گلیکوزیله بیش از 6 درصد (HbA1C <6%)
    شاخص توده بدنی بیش از 25
    پرفشار خونی کنترل نشده pre یا I stage
    HbA1c over 10%
    Fasting blood glucose more than 400 mg/dl
    Functional limitations (such as osteoarthritis)
    Liver and kidney disease
    Myocardial infarction
    Coronary artery bypass surgery or angioplasty
    Chronic heart failure
    Cardiac arrhythmia's
    Smoking
    Uncontrolled BP (BP < 170/100 mmHg)
    Insulin therapy
    HbA1C بالای 10 درصد
    گلوکز خون ناشتاس بیش از 400 mg/dl
    محدودیت های عملکردی (نظیر استئوآرتریت)
    نارسایی کبدی و کلیوی
    داشتن سابقه انفارکتوس میوکارد
    جراحی بای پس عروق کرونر یا آنژیوپلاستی
    نارسایی قلبی مزمن
    آریتمی قلبی
    سیگار کشیدن
    فشار خون کنترل نشده
    انسولین درمانی
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    Block randomization work by randomizing participants within blocks such that an equal number are assigned to each intervention groups. Given a block size in this study was 4 assign participants to a block.
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    تصادفی سازی بلوک بندی با تقسیم شرکت کننده گان در بلوک های مساوی در هریک از گروه های مداخله ای اجرا شد. اندازه بلوک های تعیین شده در این مطالعه 4 بود، بدین معنا که در هر بلوک 4 نفر اختصاص داده شده بود.
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    The participants were aware of the study. However, they did not know assigned to which groups, because they were assigned in groups based on randomization and the codes. The evaluators are specialists who were unaware of the grouping and the purpose of the study. Statistical analysis was performed by statisticians who were unaware of the study because the groups were sent to him based on coding.
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    شرکت کننده ها نسبت به مطالعه آگاه بودند با این حال آن ها نمیدانستند که در کدام گروه قرار دارند زیرا بر اساس تصادفی سازی و کدهایی که در اختیار آن ها بود در گروه ها تخصیص داده شدند. افراد ارزیابی کننده پیامد متخصصینی بودند که هیچ اطلاعی از گروه بندی و هدف مطالعه نداشتند. آنالیز آماری توسط متخصصین آمار انجام شد که نسبت به مطالعه آگاه نبودند زیرا گروه ها بر اساس کد گذاری برای او ارسال شده بود.

  • Ethics committees

    #1
    2015-12-22, 1394/10/01
    2016-07-31, 1395/05/10
    57
    IR.UT.Rec.1395002

  • Primary outcomes

    #1
    before and after 12 week intervention
    Before and after 12 week intervention
    #2
    before and after 12 week intervention
    Before and after 12 week intervention
    #3
    before and after 12 week intervention
    Before and after 12 week intervention
    #4
    before and after 12 week intervention
    Before and after 12 week intervention
    #5
    before and after 12 week intervention
    Before and after 12 week intervention
    #6
    before and after 12 week intervention
    Before and after 12 week intervention
    #7
    before and after 12 week intervention
    Before and after 12 week intervention
    #8
    before and after 12 week intervention
    Before and after 12 week intervention
    #9
    before and after 12 week intervention
    Before and after 12 week intervention
    #10
    before and after 12 week intervention
    Before and after 12 week intervention
    #11
    before and after 12 week intervention
    Before and after 12 week intervention
    روa آنزیماتیک
    روش آنزیماتیک
    #12
    before and after 12 week intervention
    Before and after 12 week intervention
    #13
    before and after 12 week intervention
    Before and after 12 week intervention
    #14
    Von willbrand factor
    Insulin
    فون ویلبراند
    انسولین
    before and after 12 week intervention
    Before and after 12 week intervention
    #15
    Insulin
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    انسولین
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    before and after 12 week intervention
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    قبل و بعد از 12 هفته مداخله
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    ELISA kit
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    کیت الایزا
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  • Intervention groups

    #1
    Intervention group1: ergometer 6* (4 minutes at 85-90% HRmax and 3 minutes active interval at 55-60% HRmax)
    Intervention group 1: High- volume high- intensity interval training that consists of 6 intervals 4 minutes at 85- 90% HRmax which separated by 3 minutes at 45-50% HRmax.
    گروه مداخله 1: دوچرخه 6 * (4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه با 3 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه)
    گروه مداخله 1: تمرین تناوبی با شدت بالا با حجم بالا که برنامه تمرینی آن ها شامل 6 تناوب 4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه که بود که هر تناوب با 3 دقیقه تناوب فعال با شدت 45- 50 درصد ضربان قلب بیشینه جدا خواهد شد
    #2
    Intervention group 2: treadmill 6* (4 minutes at 85-90% HRmax and 3 minutes active interval at 55-60% HRmax)
    Intervention group 2: High- volume high- intensity interval training that consists of 12 intervals 1.5 minutes at 85- 90% HRmax which separated by 2 minutes at 55-60% HRmax.
    گروه مداخله 2: تریدمیل 6 * (4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه با 3 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه)
    گروه مداخله 2: تمرین تناوبی با شدت بالا کم حجم که برنامه تمرینی آن ها شامل 12 تناوب 1.5 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه که بود که هر تناوب با 2 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه جدا خواهد شد
    #3
    Intervention group3: combination group including 3* (4 minutes at 85-90% HRmax and 3minute active interval at 55-60% HRmax) on treadmill and 3* (4 minutes at 85-90% HRmax and 3minute active interval at 55-60% HRmax) on ergometer.
    Intervention group3: continuous moderate intensity training consists of 42 minutes at 70% HRmax.
    گروه مداخله 3: گروه ترکیبی شامل 3 * (4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه با 3 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه) روی تریدمیل و 3 * (4 دقیقه با شدت 85-90 درصد ضربان قلب بیشینه با 3 دقیقه تناوب فعال با شدت 55-60 درصد ضربان قلب بیشینه) روی دوچرخه
    گروه مداخله 3: تمرین تداومی با شدت متوسط که شامل 42 دقیقه با شدت 70 درصد ضربان قلب بیشینه خواهد بود.

  • Recruitment centers

    #1
    Name of recruitment center - English: diabetes and metabolic disease institute of Shariati haspital
    Name of recruitment center - Persian: مرکز دیابت و بیماری های متابولیک بیمارستان شریعتی
    Full name of responsible person - English: Ensieh Nasli Esfahani MD
    Full name of responsible person - Persian: دكتر انسيه نسلي‌اصفهانی
    Street address - English:
    Street address - Persian:
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: diabetes and metabolic disease institute of Shariati haspital
    Name of recruitment center - Persian: مرکز دیابت و بیماری های متابولیک بیمارستان شریعتی
    Full name of responsible person - English: Ensieh Nasli Esfahani MD
    Full name of responsible person - Persian: دكتر انسيه نسلي‌اصفهانی
    Street address - English: Metabolism and Diabetes Center of Shariati hospital, North Kargar Street, Enghelab Square
    Street address - Persian: میدان انقلاب، خیابان کارگر شمالی، مرکز متابولیسم و دیابت بیمارستان شریعتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713135
    Phone: +98 21 0218 4901
    Fax:
    Email: shariatihosp@tums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Investigator
    Name of organization / entity - Persian: محقق
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب، خیابان کارگر شمالی،بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Investigator
    Name of organization / entity - Persian: محقق
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب، خیابان کارگر شمالی،بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1439956141
    Phone: +98 21 8835 1740
    Fax:
    Email: Ghardashi.a@ut.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
    Investigator
    Vice president of of Research of Tehran University
    محقق
    معاونت پژوهشی دانشگاه تهران

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Position - English: PhD
    Position - Persian: دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب، خیابان کارگر شمالی، بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8201 5031
    Mobile: +98 910 679 4892
    Fax:
    Email: Ghardashi.a@ut.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Position - English: PhD
    Position - Persian: دکترای تخصصی
    Latest degree: phd
    Area of specialty/work: 88
    Area of specialty/work title - English: Exercise Science, Exercise Physiology
    Area of specialty/work title - Persian: علوم ورزشی، فیزیولوژی ورزشی
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب، خیابان کارگر شمالی، بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439956141
    Phone: +98 21 8201 5031
    Mobile: +98 913 722 7732
    Fax:
    Email: Ghardashi.a@ut.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Position - English: PhD
    Position - Persian: دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب اسلامی، خیابان کارگر شمالی، بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8201 5031
    Mobile: +98 910 679 4892
    Fax:
    Email: Ghardashi.a@ut.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Position - English: PhD
    Position - Persian: دکترای تخصصی
    Latest degree: phd
    Area of specialty/work: 88
    Area of specialty/work title - English: Exercise Science, Exercise Physiology
    Area of specialty/work title - Persian: علوم ورزشی، فیزیولوژی ورزشی
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب اسلامی، خیابان کارگر شمالی، بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439956141
    Phone: +98 21 8201 5031
    Mobile: +98 913 722 7732
    Fax:
    Email: Ghardashi.a@ut.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Position - English: PhD
    Position - Persian: دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب اسلامی، خیابان کارگر شمالی، بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8201 5031
    Mobile: +98 910 679 4892
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Alireza Ghardashi Afousi
    Full name of responsible person - Persian: علیرضا قارداشی افوسی
    Position - English: PhD
    Position - Persian: دکترای تخصصی
    Latest degree: phd
    Area of specialty/work: 88
    Area of specialty/work title - English: Exercise Science, Exercise Physiology
    Area of specialty/work title - Persian: علوم ورزشی، فیزیولوژی ورزشی
    Street address - English: Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
    Street address - Persian: میدان انقلاب اسلامی، خیابان کارگر شمالی، بالاتر از چهار راه جلال آل احمد، دانشکده تربیت بدنی دانشگاه تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439956141
    Phone: +98 21 8201 5031
    Mobile: +98 913 722 7732
    Fax:
    Email: Ghardashi.a@ut.ac.ir
    Web page address:

  • Sharing plan

    no
    no
    no
    no
    no
    no
    no
    empty
    There is no further information
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
Investigation of low-volume high- intensity interval training, high- volume high- intensity interval training and continuous intensity moderate training on endothelial function of type 2 diabetes and relation with mechanisms involved in endothelial function.
Design
In this study, 70 participants divided into 4 groups low-volume high- intensity interval training, high- volume high- intensity interval training, continuous intensity moderate training and control. Randomization was performed by block randomization with a block size of 4. Randomised clinical trial with single-blind and parallel groups.
Settings and conduct
This study was performed in physical education of University of Tehran and Metabolism and Diabetes Center of Shariati hospital. Participants, outcome assessor and statistic specialist was blinded. They did not know which group they were in because they were assigned in groups based on randomization and the codes they provided. The specialists of assessment and statistical analysis were unaware of the study because the groups were sent to him based on coding.
Participants/Inclusion and exclusion criteria
Including criteria: included having a history of type 2 diabetes more than two years, glycosylated hemoglobin <6% (HbA1C <6%), body mass index over 25, hypertension uncontrolled pre or I stage, no history of 6 months of regular exercise (more than one day a week) to do the study. Exclusion criteria included fasting blood glucose over 400 mg/dl, functional limitations (such as osteoarthritis), liver or kidney failure, history of myocardial infarction or coronary artery bypass surgery or angioplasty, chronic heart failure, cardiac arrhythmias, smoking, insulin therapy and HbA1C > 10%.
Intervention groups
1. High- volume high- intensity interval training that program was including 6 intervals 4 minutes at 85-90% HRmax that separated by 3 minutes active period at 45- 50% HRmax. 2. Low- volume high- intensity interval training that program was including 12 intervals 1.5 minutes at 85-90% HRmax that separated by 2 minutes active period at 55- 60% HRmax. 3. Continues moderate intensity training consist of 42 minutes at 70% HRmax. 4. Control group that maintenance daily activities and no have regular exercise.
Main outcome variables
Flow-mediated dilation; Diameter at baseline; Diameter at peak; Antegrade shear rate؛ Retrograde shear rate؛ Oscillatory shear index؛ Nitrite/ Nitrate; Endothelin-1; Apelin; Arterial stiffness; Superoxide dismutase; Malondialdehyde; Carotid intima-media thickness; Resistance insulin; Lipid profile; VO2peak; exercise time; Resting and maximal heart rate; Resting diastolic blood pressure; Resting systolic blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2015100423002N2
Registration date: 2016-03-04, 1394/12/14
Registration timing: registered_while_recruiting

Last update: 2018-02-06, 1396/11/17
Update count: 1
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Alireza Ghardashi Afousi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8201 5031
Email address
ghardashi.a@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
2015-05-05, 1394/02/15
Actual recruitment end date
2016-04-24, 1395/02/05
Trial completion date
empty
Scientific title
Effect of differential exercise training on endothelial function of type 2 diabetes and relation with inflammatory cytokines
Public title
Effect of exercise training on endothelial function of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of type 2 diabetes more than 2 years No history of 6 months of regular exercise Glycosylated hemoglobin <6%(HbA1C <6%) Body mass index over 25 Hypertension uncontrolled pre or I stage
Exclusion criteria:
HbA1c over 10% Fasting blood glucose more than 400 mg/dl Functional limitations (such as osteoarthritis) Liver and kidney disease Myocardial infarction Coronary artery bypass surgery or angioplasty Chronic heart failure Cardiac arrhythmia's Smoking Uncontrolled BP (BP < 170/100 mmHg) Insulin therapy
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization work by randomizing participants within blocks such that an equal number are assigned to each intervention groups. Given a block size in this study was 4 assign participants to a block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were aware of the study. However, they did not know assigned to which groups, because they were assigned in groups based on randomization and the codes. The evaluators are specialists who were unaware of the grouping and the purpose of the study. Statistical analysis was performed by statisticians who were unaware of the study because the groups were sent to him based on coding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Tehran
Street address
16th Azar Street, Enghelab Square, Central Organization of University of Tehran
City
Tehran
Province
Tehran
Postal code
۶۶۱۹-۱۴۱۵۵
Approval date
2016-07-31, 1395/05/10
Ethics committee reference number
IR.UT.Rec.1395002

Health conditions studied

1

Description of health condition studied
type 2diabetes
ICD-10 code
E 11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Nitrite/Nitrate plasma
Timepoint
Before and after 12 week intervention
Method of measurement
ELISA kit

2

Description
Endothelin-1
Timepoint
Before and after 12 week intervention
Method of measurement
ELISA kit

3

Description
Flow mediated dilation
Timepoint
Before and after 12 week intervention
Method of measurement
Ultrasound doppler

4

Description
Carotid intima-media thickness
Timepoint
Before and after 12 week intervention
Method of measurement
Ultrasound doppler

5

Description
Insulin resistance
Timepoint
Before and after 12 week intervention
Method of measurement
HOMA-IR

6

Description
Glucose
Timepoint
Before and after 12 week intervention
Method of measurement
Enzymatic

7

Description
Applin
Timepoint
Before and after 12 week intervention
Method of measurement
ELISA kit

8

Description
peak consumption oxygen
Timepoint
Before and after 12 week intervention
Method of measurement
Gas analyser system

9

Description
Diastolic and systolic blood pressure
Timepoint
Before and after 12 week intervention
Method of measurement
oscillometric device

10

Description
Heart rate rest
Timepoint
Before and after 12 week intervention
Method of measurement
Cornometer/ numbere

11

Description
Lipid profile
Timepoint
Before and after 12 week intervention
Method of measurement
Enzymatic

12

Description
Malondealdehid
Timepoint
Before and after 12 week intervention
Method of measurement
ELISA kit

13

Description
Glutathion proxidase
Timepoint
Before and after 12 week intervention
Method of measurement
ELISA kit

14

Description
Insulin
Timepoint
Before and after 12 week intervention
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: High- volume high- intensity interval training that consists of 6 intervals 4 minutes at 85- 90% HRmax which separated by 3 minutes at 45-50% HRmax.
Category
Rehabilitation

2

Description
Intervention group 2: High- volume high- intensity interval training that consists of 12 intervals 1.5 minutes at 85- 90% HRmax which separated by 2 minutes at 55-60% HRmax.
Category
Rehabilitation

3

Description
Intervention group3: continuous moderate intensity training consists of 42 minutes at 70% HRmax.
Category
Rehabilitation

4

Description
Control group: normal condition without any exercise
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
diabetes and metabolic disease institute of Shariati haspital
Full name of responsible person
Ensieh Nasli Esfahani MD
Street address
Metabolism and Diabetes Center of Shariati hospital, North Kargar Street, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0218 4901
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Alireza Ghardashi Afousi
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Province
Tehran
Postal code
1439956141
Phone
+98 21 8835 1740
Email
Ghardashi.a@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice president of of Research of Tehran University
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
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Science, Exercise Physiology
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Province
Tehran
Postal code
1439956141
Phone
+98 21 8201 5031
Fax
Email
Ghardashi.a@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Science, Exercise Physiology
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Province
Tehran
Postal code
1439956141
Phone
+98 21 8201 5031
Fax
Email
Ghardashi.a@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Science, Exercise Physiology
Street address
Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.
City
Tehran
Province
Tehran
Postal code
1439956141
Phone
+98 21 8201 5031
Fax
Email
Ghardashi.a@ut.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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