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Protocol summary
Objective: Favorable effects of the Dietary Approaches to Stop Hypertension (DASH) diet on glucose tolerance and lipid profiles in gestational diabetes. Study design: parallel randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation were included in this study. Elective subjects should not use replace treatments like Hormone or supplemental vitamin. Also those patients with preeclampsia and complete bed rest. Population and sample size: 40 patients with GDM among pregnant women of eligible and referred to Naghavi clinic in Kashan, in the study was selected. Intervention: These patients were divided to either an intervention group (DASH diet) or control group (standard diet) groups. After an overnight fasting, subjects referred for blood drawn. After this stage, blood samples tested. After 4 weeks of experiment, fasting blood samples were tested again. Start and End Date of Intervention: 4 weeks (April 17, 2012- May 17, 2012). Outcomes: Baseline serum total cholesterol, LDL-cholesterol, HDL-cholesterol and TG, plasma glucose, serum insulin, hs-CRP, calcium, iron, zinc, HOMA-IR score, plasma TAC (total antioxidant capacity) and total glutathione.
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Objective: Favorable effects of the Dietary Approaches to Stop Hypertension (DASH) diet on glucose tolerance and lipid profiles in gestational diabetes. Study design: parallel randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation were included in this study. Elective subjects should not use replace treatments like Hormone or supplemental vitamin. Also those patients with preeclampsia and complete bed rest. Population and sample size: 40 patients with GDM among pregnant women of eligible and referred to Naghavi clinic in Kashan, in the study was selected. Intervention: These patients were divided to either an intervention group (DASH diet) or control group (standard diet) groups. After an overnight fasting, subjects referred for blood drawn. After this stage, blood samples tested. After 4 weeks of experiment, fasting blood samples were tested again. Start and End Date of Intervention: 4 weeks (April 17, 2012- May 17, 2012). Outcomes: Baseline serum total cholesterol, LDL-cholesterol, HDL-cholesterol and TG, plasma glucose, serum insulin, hs-CRP, calcium, iron, zinc, HOMA-IR score, plasma TAC (total antioxidant capacity) and total glutathione.
هدف: اثرات مطلوب راهکارهای رژیمی متوقف کننده فشار خون (DASH) روی تحمل گلوکز و پروفایل های لیپیدی در دیابت بارداری. طراحی مطالعه: تصادفي، کارآزمایی بالینی یک سوکور موازی. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد شدند. افراد انتخابي نبايد از درمان های جايگزين با هورمون يا مكمل هاي ويتاميني استفاده می کردند. همچنين افراد مبتلا به پره اکلامسی و استراحت مطلق از ليست افراد واجد شرايط حذف شدند. حجم نمونه و جمعیت مورد مطالعه: 40 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک نقوی کاشان، در مطالعه انتخاب شدند. مداخله مورد مطالعه: این بیماران به دو گروه مداخله (رژیم DASH) و گروه کنترل (رژیم استاندارد) تقسیم شدند. پس از یک شب ناشتایی، از افراد خونگیری شده و نمونه خون برای آزمایش فرستاده شد. پس از 4 هفته نمونه خون حالت ناشتا دوباره مورد آزمایش قرار گرفتند. زمان مداخله: 4 هفته (از 29 فروردین 1391 تا 29 اردیبهشت 1391) پيامد های اوليه مورد مطالعه: سطح سرمی کلسترول توتال،LDL - C ، HDL-C و TG ، گلوکز پلاسما، سطح سرمی انسولین، HS - CRP ، کلسیم، آهن، روی، اندیس HOMA-IR، توتال آنتی اکسیدان پلاسما و گلوتاتیون توتال
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هدف: اثرات مطلوب راهکارهای رژیمی متوقف کننده فشار خون (DASH) روی تحمل گلوکز و پروفایل های لیپیدی در دیابت بارداری. طراحی مطالعه: تصادفي، کارآزمایی بالینی یک سوکور موازی. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد شدند. افراد انتخابي نبايد از درمان های جايگزين با هورمون يا مكمل هاي ويتاميني استفاده می کردند. همچنين افراد مبتلا به پره اکلامسی و استراحت مطلق از ليست افراد واجد شرايط حذف شدند. حجم نمونه و جمعیت مورد مطالعه: 40 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک نقوی کاشان، در مطالعه انتخاب شدند. مداخله مورد مطالعه: این بیماران به دو گروه مداخله (رژیم DASH) و گروه کنترل (رژیم استاندارد) تقسیم شدند. پس از یک شب ناشتایی، از افراد خونگیری شده و نمونه خون برای آزمایش فرستاده شد. پس از 4 هفته نمونه خون حالت ناشتا دوباره مورد آزمایش قرار گرفتند. زمان مداخله: 4 هفته (از 29 فروردین 1391 تا 29 اردیبهشت 1391) پيامد های اوليه مورد مطالعه: سطح سرمی کلسترول توتال،LDL - C ، HDL-C و TG ، گلوکز پلاسما، سطح سرمی انسولین، HS - CRP ، کلسیم، آهن، روی، اندیس HOMA-IR، توتال آنتی اکسیدان پلاسما و گلوتاتیون توتال
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Favorable effects of the Dietary Approaches to Stop Hypertension (DASH) diet on glucose tolerance and lipid profiles in gestational diabetes.
Favorable effects of the Dietary Approaches to Stop Hypertension (DASH) diet on glucose tolerance and lipid profiles in gestational diabetes.
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اثرات مطلوب راهکارهای رژیمی متوقف کننده فشار خون (DASH) روی تحمل گلوکز و پروفایل های لیپیدی در دیابت بارداری.
اثرات مطلوب راهکارهای رژیمی متوقف کننده فشار خون (DASH) روی تحمل گلوکز و پروفایل های لیپیدی در دیابت بارداری.
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Randomized clinical trial.
Randomized clinical trial.
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طراحي انجام مطالعه: کارآزمایی بالینی تصادفی.
طراحي انجام مطالعه: کارآزمایی بالینی تصادفی.
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Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, 78 patients will be selected according to inclusion and exclusion criteria. Fasting blood samples will be taken at baseline and 4 weeks after the intervention. At the beginning and the end of the intervention: 4 weeks.
Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, 78 patients will be selected according to inclusion and exclusion criteria. Fasting blood samples will be taken at baseline and 4 weeks after the intervention. At the beginning and the end of the intervention: 4 weeks.
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از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان، 78 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 4 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 4 هفته.
از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان، 78 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 4 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 4 هفته.
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Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation were included in this study. Elective subjects should not use replace treatments like Hormone or supplemental vitamin. Also those patients with preeclampsia and complete bed rest.
Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation were included in this study. Elective subjects should not use replace treatments like Hormone or supplemental vitamin. Also those patients with preeclampsia and complete bed rest.
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معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد شدند. افراد انتخابي نبايد از درمان های جايگزين با هورمون يا مكمل هاي ويتاميني استفاده می کردند. همچنين افراد مبتلا به پره اکلامسی و استراحت مطلق از ليست افراد واجد شرايط حذف شدند.
معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد شدند. افراد انتخابي نبايد از درمان های جايگزين با هورمون يا مكمل هاي ويتاميني استفاده می کردند. همچنين افراد مبتلا به پره اکلامسی و استراحت مطلق از ليست افراد واجد شرايط حذف شدند.
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Intervention: These patients were divided to 4 groups: intervention 1 (20 participants), control 1 (20 participants), intervention 2 (19 participants) and control 2 (19 participants).
Intervention: These patients were divided to 4 groups: intervention 1 (20 participants), control 1 (20 participants), intervention 2 (19 participants) and control 2 (19 participants).
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مداخله مورد مطالعه: این بیماران به 4 گروه: مداخله 1 (20 نفر)، کنترل 1 (20 نفر)، مداخله 2 (19 نفر) و کنترل 2 (19 نفر) تقسیم شدند.
مداخله مورد مطالعه: این بیماران به 4 گروه: مداخله 1 (20 نفر)، کنترل 1 (20 نفر)، مداخله 2 (19 نفر) و کنترل 2 (19 نفر) تقسیم شدند.
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Outcomes: Markers of HDL-cholesterol and hs-CRP (primary outcomes) and other lipid profiles and glycemic control (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Markers of HDL-cholesterol and hs-CRP (primary outcomes) and other lipid profiles and glycemic control (secondary outcomes) will be quantified at study baseline and end-of-trial.
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پيامدها: کلسترول HDL و hs-CRP (پیامدهای اولیه) و سایر پروفایل های لیپیدی و گلیسمیک کنترل (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: کلسترول HDL و hs-CRP (پیامدهای اولیه) و سایر پروفایل های لیپیدی و گلیسمیک کنترل (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
40
78
4078
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 weeks' gestation
Pregnant women aged 18-40 years Diagnosed with GDM at 24-28 weeks' gestation
نان باردار 40-18 ساله
مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
نان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
Use replace treatments like hormone
Patients with preeclampsia
Complete bed rest
Use replace treatments like hormone Patients with preeclampsia Complete bed rest
استفاده از درمان های جايگزين مانند هورمون
افراد مبتلا به پره اکلامسی
استراحت مطلق
استفاده از درمان های جايگزين مانند هورمون افراد مبتلا به پره اکلامسی استراحت مطلق
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Participants will be randomly allocated into two treatment groups to take either DASH or control diets. Randomization will be done by the use of computer software.
Participants will be randomly allocated into two treatment groups to take either DASH or control diets. Randomization will be done by the use of computer software.
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شرکت کنندگان به طور تصادفی به دو گروه برای دریافت رژیم DASH یا کنترل تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
شرکت کنندگان به طور تصادفی به دو گروه برای دریافت رژیم DASH یا کنترل تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
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Primary outcomes
#1
TG
HDL-cholesterol
TGHDL-cholesterol
تری گلیسیرید
کلسترول HDL
تری گلیسیریدکلسترول HDL
the first and end intervention
The first and end intervention
theThe first and end intervention
#2
Total cholesterol
hs-CRP
Total cholesterolhs-CRP
کلسترول
پروتئین واکنشکر C
کلسترولپروتئین واکنشکر C
the first and end intervention
The first and end intervention
theThe first and end intervention
Enzymatic
Elisa
EnzymaticElisa
آنزیمی
الایزا
آنزیمیالایزا
#3
Total antioxidant
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Total antioxidant
توتال آنتی اکسیدان
empty
توتال آنتی اکسیدان
the first and end intervention
empty
the first and end intervention
ابتدا و انتهای مداخله
empty
ابتدا و انتهای مداخله
Spectrophotometric
empty
Spectrophotometric
اسپکتروفتومتری
empty
اسپکتروفتومتری
#4
Total glutathione
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Total glutathione
گلوتاتیون توتال
empty
گلوتاتیون توتال
the first and end intervention
empty
the first and end intervention
ابتدا و انتهای مداخله
empty
ابتدا و انتهای مداخله
Spectrophotometric
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Spectrophotometric
اسپکتروفتومتری
empty
اسپکتروفتومتری
#5
Serum calcium
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Serum calcium
کلسیم سرم
empty
کلسیم سرم
the first and end intervention
empty
the first and end intervention
ابتدا و انتهای مداخله
empty
ابتدا و انتهای مداخله
Enzymatic
empty
Enzymatic
آنزیمی
empty
آنزیمی
#6
Plasma gucose
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Plasma gucose
گلوکز پلاسما
empty
گلوکز پلاسما
the first and end intervention
empty
the first and end intervention
ابتدا و انتهای مداخله
empty
ابتدا و انتهای مداخله
Enzymatic
empty
Enzymatic
آنزیمی
empty
آنزیمی
#7
Seum insulin
empty
Seum insulin
انسولین سرم
empty
انسولین سرم
the first and end intervention
empty
the first and end intervention
ابتدا و انتهای مداخله
empty
ابتدا و انتهای مداخله
Elisa
empty
Elisa
الایزا
empty
الایزا
#8
hs-CRP
empty
hs-CRP
پروتئین واکنشکر C
empty
پروتئین واکنشکر C
the first and end intervention
empty
the first and end intervention
ابتدا و انتهای مداخله
empty
ابتدا و انتهای مداخله
Elisa
empty
Elisa
الایزا
empty
الایزا
Secondary outcomes
#1
empty
Insulin resistance
Insulin resistance
empty
مقاومت به انسولین
مقاومت به انسولین
empty
At the beginning of the study and after 4 weeks of intervention
At the beginning of the study and after 4 weeks of intervention
empty
در ابتدای مطالعه و 4 هفته بعد از مداخله
در ابتدای مطالعه و 4 هفته بعد از مداخله
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Calculation using HOMA formula
Calculation using HOMA formula
empty
محاسبه با استفاده از فرمول HOMA
محاسبه با استفاده از فرمول HOMA
#2
empty
Insulin
Insulin
empty
انسولین
انسولین
empty
At the beginning of the study and after 4 weeks of intervention
At the beginning of the study and after 4 weeks of intervention
empty
در ابتدای مطالعه و 4 هفته بعد از مداخله
در ابتدای مطالعه و 4 هفته بعد از مداخله
empty
Elisa kit
Elisa kit
empty
کیت الایزا
کیت الایزا
#3
empty
Total cholesterol
Total cholesterol
empty
کلسترول توتال
کلسترول توتال
empty
At the beginning of the study and after 4 weeks of intervention
At the beginning of the study and after 4 weeks of intervention
empty
در ابتدای مطالعه و 4 هفته بعد از مداخله
در ابتدای مطالعه و 4 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#4
empty
Triglycerides
Triglycerides
empty
تری گلیسرید
تری گلیسرید
empty
At the beginning of the study and after 4 weeks of intervention
At the beginning of the study and after 4 weeks of intervention
empty
در ابتدای مطالعه و 4 هفته بعد از مداخله
در ابتدای مطالعه و 4 هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#5
empty
Total antioxidant capacity
Total antioxidant capacity
empty
ظرفیت آنتی اکسیدانی توتال
ظرفیت آنتی اکسیدانی توتال
empty
At the beginning of the study and after 4 weeks of intervention
At the beginning of the study and after 4 weeks of intervention
empty
در ابتدای مطالعه و 4 هفته بعد از مداخله
در ابتدای مطالعه و 4 هفته بعد از مداخله
empty
Spectrophotometry
Spectrophotometry
empty
اسپکتروفتومتری
اسپکتروفتومتری
#6
empty
Glutathione
Glutathione
empty
گلوتاتیون
گلوتاتیون
empty
At the beginning of the study and after 4 weeks of intervention
At the beginning of the study and after 4 weeks of intervention
empty
در ابتدای مطالعه و 4 هفته بعد از مداخله
در ابتدای مطالعه و 4 هفته بعد از مداخله
empty
Spectrophotometry
Spectrophotometry
empty
اسپکتروفتومتری
اسپکتروفتومتری
Recruitment centers
#1
Name of recruitment center - English: Naghavi clinic Kashan
Name of recruitment center - Persian: کلینیک نقوی کاشان
Full name of responsible person - English: Dr Mansooreh Samimi
Full name of responsible person - Persian: دکتر منصوره صمیمی
Street address - English:
Street address - Persian:
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: Naghavi clinic Kashan
Name of recruitment center - Persian: کلینیک نقوی کاشان
Full name of responsible person - English: Dr Mansooreh Samimi
Full name of responsible person - Persian: دکتر منصوره صمیمی
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 5545 1515
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Naghavi clinic Kashan Name of recruitment center - Persian: کلینیک نقوی کاشان Full name of responsible person - English: Dr Mansooreh Samimi Full name of responsible person - Persian: دکتر منصوره صمیمی 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 5545 1515 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Dr Gholamali Hamidi
Full name of responsible person - Persian: دکتر غلامعلی حمیدی
Street address - English: Ravandi ghotbe avenue, 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: Dr Gholamali Hamidi
Full name of responsible person - Persian: دکتر غلامعلی حمیدی
Street address - English: Ravandi ghotbe avenue, 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 5554 0021
Fax:
Email: hamidi_gh@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Dr Gholamali Hamidi Full name of responsible person - Persian: دکتر غلامعلی حمیدی Street address - English: Ravandi ghotbe avenue, 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 5554 0021 Fax: Email: hamidi_gh@kaums.ac.ir Web page address:
empty
Public
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:
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Area of specialty/work title - Persian:
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Street address - Persian:
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: 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_r@yahoo.com
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: 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_r@yahoo.com 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 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: Ravandi ghotbe anenue
Street address - Persian: 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 36 1446 3378
Mobile: 00
Fax:
Email: asemi_za@yahoo.comasemi_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 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: Ravandi ghotbe anenue
Street address - Persian: 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: 0098 36 1446 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_za@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 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: Ravandi ghotbe anenue Street address - Persian: 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: +980098 36 1446 3378 Mobile: 00+98 913 361 5446 Fax: Email: asemi_za@yahoo.comasemi_z@kaums.ac.iryahoo.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 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: Ravandi ghotbe avenue, 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 36 1446 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_za@yahoo.comasemi_z@kaums.ac.ir
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 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: Ravandi ghotbe avenue, 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: 0098 36 1446 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_za@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 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: Ravandi ghotbe avenue, 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: +980098 36 1446 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_za@yahoo.comasemi_z@kaums.ac.iryahoo.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
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
Favorable effects of the Dietary Approaches to Stop Hypertension (DASH) diet on glucose tolerance and lipid profiles in gestational diabetes.
Design
Randomized clinical trial.
Settings and conduct
Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, 78 patients will be selected according to inclusion and exclusion criteria. Fasting blood samples will be taken at baseline and 4 weeks after the intervention. At the beginning and the end of the intervention: 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation were included in this study. Elective subjects should not use replace treatments like Hormone or supplemental vitamin. Also those patients with preeclampsia and complete bed rest.
Intervention groups
Intervention: These patients were divided to 4 groups: intervention 1 (20 participants), control 1 (20 participants), intervention 2 (19 participants) and control 2 (19 participants).
Main outcome variables
Outcomes: Markers of HDL-cholesterol and hs-CRP (primary outcomes) and other lipid profiles and glycemic control (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201204065623N2
Registration date:2012-04-09, 1391/01/21
Registration timing:prospective
Last update:2019-08-15, 1398/05/24
Update count:1
Registration date
2012-04-09, 1391/01/21
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
2012-04-17, 1391/01/29
Expected recruitment end date
2012-05-17, 1391/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of the Dietary Approaches to Stop Hypertension (DASH) on glucose tolerance and lipid profiles in gestational diabetes
Public title
effect of Diet theraphy in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
Use replace treatments like hormone
Patients with preeclampsia
Complete bed rest
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated into two treatment groups to take either DASH or control diets. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ravandi ghotbe avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2011-08-09, 1390/05/18
Ethics committee reference number
9013
Health conditions studied
1
Description of health condition studied
Diabetes mellitus in pregnancy
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
HDL-cholesterol
Timepoint
The first and end intervention
Method of measurement
Enzymatic
2
Description
hs-CRP
Timepoint
The first and end intervention
Method of measurement
Elisa
Secondary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Calculation using HOMA formula
2
Description
Insulin
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Elisa kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Glutathione
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: DASH diet, 6 serving Vegetables, 6 serving frutits, rich in fiber, whole grains, daily for 4 weeks
Category
Other
2
Description
Control group: Standard diet, 4 serving Vegetables, 4 serving fruits, rich in protein, daily for 4 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi clinic Kashan
Full name of responsible person
Dr Mansooreh Samimi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5545 1515
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Ravandi ghotbe avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
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
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ravandi ghotbe anenue
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
0098 36 1446 3378
Fax
Email
asemi_za@yahoo.com
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 Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ravandi ghotbe avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
0098 36 1446 3378
Fax
Email
asemi_za@yahoo.com
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