Evaluation of the effects of astaxanthin on markers related to autophagy and study of inflammatory activity by expression of microRNAs in type ۲ diabetic patients are treated with metformin
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Protocol summary
Determining the effect of astaxanthin supplement on glycemic indexes and oxidative stress markers and
Glomerular and tubular markers in type 2 diabetic patients treated by metformin
Determination of the effect of astaxanthin on autophagic pathway and study of inflammatory activities by gene expression of inflammatory-related microRNAs in patients with type 2 diabetes treated with metformin
DeterminingDetermination of the effect of astaxanthin supplement on glycemic indexesautophagic pathway and oxidative stress markers and Glomerular and tubular markersstudy of inflammatory activities by gene expression of inflammatory-related microRNAs in patients with type 2 diabetic patientsdiabetes treated bywith metformin
تعیین اثر مکمل یاری آستازانتین بر شاخص های گلایسمیک و مارکرهای استرس اکسیداتیو و مارکرهای گلومرولار و توبولار در بیماران مبتلا به دیابت نوع 2 تحت درمان با متفورمین
تعیین اثر استازانتین بر مسیر اتوفاژیک و مطالعه فعالیت های التهابی بوسیله بیان ژن میکروRNA های مرتبط با التهاب در بیماران مبتلا به دیابت نوع ۲ تحت درمان با متفورمین
تعیین اثر مکمل یاری آستازانتیناستازانتین بر شاخصمسیر اتوفاژیک و مطالعه فعالیت های گلایسمیک و مارکرهای استرس اکسیداتیو و مارکرهای گلومرولار و توبولارالتهابی بوسیله بیان ژن میکروRNA های مرتبط با التهاب در بیماران مبتلا به دیابت نوع 2۲ تحت درمان با متفورمین
The study population was from patients referring to Endocrine and Metabolism Research Center of Isfahan and conducted tests at the Faculty of Pharmacy of Isfahan University of Medical Sciences.
The following biochemical parameters are measured in two groups of treatment and control before and 8 weeks after treatment: blood glucose and glycosylated sugar, blood lipids, uric acid, serum creatinine, and blood urea
Investigation of Gluconeogenesis on RBC by RT-PCR
Evaluation of cell signaling protein expression on white blood cells by western blot method
Evaluation of urinary malondialdehyde levels, advanced oxidation protein products
Evaluation of levels of cystatin C and neutrophil gelatinase lipocalin-related
The study population was from patients referring to Endocrine and Metabolism Research Center of Isfahan and conducted tests at the Faculty of Pharmacy of Isfahan University of Medical Sciences.
The following biochemical parameters are measured in two groups of treatment and control before and 8 weeks after treatment: blood glucose and glycosylated sugar, blood lipids, uric acid, serum creatinine, and blood urea
Evaluation of autophagic gene expression on PBMC by RT-PCR method
Expression of autophagic proteins (Atg-5, ATg-7) by Western blotting method
Evaluation of serum levels of inflammatory markers (TNF-a, IL-6, IL-1B)
Expression of inflammatory-related microRNAs (MiR-155,21,34a)
Evaluation of insulin resistance and oxidative markers (aHB, LysoPC)
The study population was from patients referring to Endocrine and Metabolism Research Center of Isfahan and conducted tests at the Faculty of Pharmacy of Isfahan University of Medical Sciences. The following biochemical parameters are measured in two groups of treatment and control before and 8 weeks after treatment: blood glucose and glycosylated sugar, blood lipids, uric acid, serum creatinine, and blood urea InvestigationEvaluation of Gluconeogenesisautophagic gene expression on RBCPBMC by RT-PCR Evaluationmethod Expression of cell signaling protein expression on white blood cellsautophagic proteins (Atg-5, ATg-7) by western blotWestern blotting method Evaluation of urinary malondialdehydeserum levels of inflammatory markers (TNF-a, advanced oxidation protein productsIL-6, IL-1B) Expression of inflammatory-related microRNAs (MiR-155,21,34a) Evaluation of levels of cystatin Cinsulin resistance and neutrophil gelatinase lipocalin-relatedoxidative markers (aHB, LysoPC)
جمعیت مورد مطالعه از بین مراجعین به مرکز تحقیقات غدد و متابولیسم اصفهان است و انجام آزمایشات در دانشکده داروسازی دانشگاه علوم پزشکی اصفهان می باشد.
در دو گروه درمانی و کنترل قبل از درمان و 8 هفته بعد از درمان پارامترهای بیوشیمیایی زیر سنجیده می شود : قند خون و قند گلیکوزیله، شاخصه های چربی خون، اسید اوریک و کراتینین سرم و اوره خون
سایر تست ها :
بررسی بیان ژن های گلوکونئوژنز بر روی گلبول های سفید به روش ریل تایم پی سی آر
بررسی بیان پروتئین سیگنالینگ سلولی بر روی گلبول های سفید به روش وسترن بلات
بررسی سطح مالون دی آلدهید ادراری،محصولات پروتیئنی اکسیداسیون شده پیشرفته
بررسی سطح سیستاتین سی و نوتروفیل ژلاتیناز مرتبط با لیپوکالین
جمعیت مورد مطالعه از بین مراجعین به مرکز تحقیقات غدد و متابولیسم اصفهان است و انجام آزمایشات در دانشکده داروسازی دانشگاه علوم پزشکی اصفهان می باشد.
در دو گروه درمانی و کنترل قبل از درمان و 8 هفته بعد از درمان پارامترهای بیوشیمیایی زیر سنجیده می شود : قند خون و قند گلیکوزیله، شاخصه های چربی خون، اسید اوریک و کراتینین سرم و اوره خون
سایر تست ها :
بررسی بیان ژن های اتوفاژیک بر روی PBMC به روش ریل تایم پی سی آر
بررسی بیان پروتئین های اتوفاژیک (Atg-5, ATg-7) به روش وسترن بلات
بررسی سطح سرمی مارکرهای التهابی (TNF-a, IL-6, IL-1B)
بررسی بیان میکروRNA های مرتبط با التهاب (MiR-155,21,34a)
بررسی سطح مارکرهای مقاومت به انسولین و اکسیداتیو ( aHB, LysoPC)
جمعیت مورد مطالعه از بین مراجعین به مرکز تحقیقات غدد و متابولیسم اصفهان است و انجام آزمایشات در دانشکده داروسازی دانشگاه علوم پزشکی اصفهان می باشد. در دو گروه درمانی و کنترل قبل از درمان و 8 هفته بعد از درمان پارامترهای بیوشیمیایی زیر سنجیده می شود : قند خون و قند گلیکوزیله، شاخصه های چربی خون، اسید اوریک و کراتینین سرم و اوره خون سایر تست ها : بررسی بیان ژن های گلوکونئوژنزاتوفاژیک بر روی گلبول های سفیدPBMC به روش ریل تایم پی سی آر بررسی بیان پروتئین سیگنالینگ سلولی بر روی گلبول های سفیداتوفاژیک (Atg-5, ATg-7) به روش وسترن بلات بررسی سطح مالون دی آلدهید ادراری،محصولات پروتیئنی اکسیداسیون شده پیشرفتهسرمی مارکرهای التهابی (TNF-a, IL-6, IL-1B) بررسی بیان میکروRNA های مرتبط با التهاب (MiR-155,21,34a) بررسی سطح سیستاتین سیمارکرهای مقاومت به انسولین و نوتروفیل ژلاتیناز مرتبط با لیپوکالیناکسیداتیو ( aHB, LysoPC)
(Age)Increasing the efficacy of treatment in improving the oxidative index
and Glomerular and tubular of patients and serum lipid and enzyme indices of serum and signaling routes
Increasing the efficacy of treatment in improving inflammatory, autophagic, insulin resistance and oxidative indexes
(Age)IncreasingIncreasing the efficacy of treatment in improving theinflammatory, autophagic, insulin resistance and oxidative index and Glomerular and tubular of patients and serum lipid and enzyme indices of serum and signaling routesindexes
افزایش اثر بخشی درمان در بهبود شاخص اکسیداتیو و شاخص های گلومرولار و توبولار بیماران و شاخص های لیپیدی و آنزیمی سرم و مسیرهای پیام رسانی
افزایش اثر بخشی درمان در بهبود شاخص های التهابی، اتوفاژیک، مقاومت به انسولین و اکسیداتیو
افزایش اثر بخشی درمان در بهبود شاخص اکسیداتیوهای التهابی، اتوفاژیک، مقاومت به انسولین و شاخص های گلومرولار و توبولار بیماران و شاخص های لیپیدی و آنزیمی سرم و مسیرهای پیام رسانیاکسیداتیو
General information
Evaluation of the effect of astaxanthin supplementation on glomerular and tubular markers and markers of oxidative stress in patients with type 2 diabetes treated with metformin (Continued study on available samples)
Evaluation of the effects of astaxanthin on markers related to autophagy and study of inflammatory activity by expression of microRNAs in type ۲ diabetic patients are treated with metformin (Continued study on available samples)
Evaluation of the effecteffects of astaxanthin supplementation on glomerularmarkers related to autophagy and tubular markers and markersstudy of oxidative stressinflammatory activity by expression of microRNAs in type ۲ diabetic patients with type 2 diabetesare treated with metformin (Continued study on available samples)
بررسی اثر بررسی اثر مکمل یاری آستازانتین بر شاخص های گلومرولی و توبولی و مارکرهای استرس اکسیداتیو در بیماران مبتلا به دیابت نوع 2 تحت درمان با مت فورمین( ادامه مطالعه بر روی نمونه های موجود)
بررسی اثرات استازانتین (Astaxanthin) بر مارکرهای مرتبط با اتوفاژی و مطالعه فعالیت های التهابی، بوسیله بیان میکرو RNA ها در بیماران دیابتی نوع ۲ تحت درمان با متفورمین( ادامه مطالعه بر روی نمونه های موجود)
بررسی اثر بررسی اثر مکمل یاری آستازانتیناثرات استازانتین (Astaxanthin) بر شاخصمارکرهای مرتبط با اتوفاژی و مطالعه فعالیت های گلومرولی و توبولی و مارکرهای استرس اکسیداتیوالتهابی، بوسیله بیان میکرو RNA ها در بیماران مبتلا به دیابتدیابتی نوع 2۲ تحت درمان با مت فورمینمتفورمین( ادامه مطالعه بر روی نمونه های موجود)
Evaluating the effect of astaxanthin supplement on glycemic indexes and oxidative stress markers and glomerular and tubular markers in type 2 diabetic patients Treated by metformin
Evaluation of the effects of astaxanthin on markers related to autophagy and study of inflammatory activity by expression of microRNAs in type ۲ diabetic patients are treated with metformin
EvaluatingEvaluation of the effecteffects of astaxanthin supplement on glycemic indexesmarkers related to autophagy and oxidative stress markers and glomerular and tubular markersstudy of inflammatory activity by expression of microRNAs in type 2۲ diabetic patients Treated byare treated with metformin
بررسی اثر مکمل یاری آستازانتین بر شاخص های گلایسمیک و مارکرهای استرس اکسیداتیو و مارکرهای گلومرولار و توبولار در بیماران مبتلا به دیابت نوع 2 تحت درمان با مت فورمین
بررسی اثرات استازانتین (Astaxanthin) بر مارکرهای مرتبط با اتوفاژی و مطالعه فعالیت های التهابی، بوسیله بیان میکرو RNA ها در بیماران دیابتی نوع ۲ تحت درمان با متفورمین
بررسی اثر مکمل یاری آستازانتیناثرات استازانتین (Astaxanthin) بر شاخصمارکرهای مرتبط با اتوفاژی و مطالعه فعالیت های گلایسمیک و مارکرهای استرس اکسیداتیو و مارکرهای گلومرولار و توبولارالتهابی، بوسیله بیان میکرو RNA ها در بیماران مبتلا به دیابتدیابتی نوع 2۲ تحت درمان با مت فورمینمتفورمین
Ethics committees
#1
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2022-03-29, 1401/01/09
2022-03-29 00:00:00
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IR.SUMS.REC.1401.029
IR.SUMS.REC.1401.029
Primary outcomes
#1
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Inflammation, insulin resistance and oxidative Indexes: Following the intervention, we expect the inflammation Indexes of the patient group (treated with astaxantin and metformin) to differ from the control group (placebo and metformin)
Inflammation, insulin resistance and oxidative Indexes: Following the intervention, we expect the inflammation Indexes of the patient group (treated with astaxantin and metformin) to differ from the control group (placebo and metformin)
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شاخص های التهابی، مقاومت به انسولین و اکسیداتیو :به دنبال مداخله ای که انجام می شود انتظار داریم شاخص های التهابی گروه بیماران (تحت درمان با آستازانتین و مت فورمین) نسبت به گروه کنترل(دارونما و مت فورمین) تفاوت پیدا کنند.
شاخص های التهابی، مقاومت به انسولین و اکسیداتیو :به دنبال مداخله ای که انجام می شود انتظار داریم شاخص های التهابی گروه بیماران (تحت درمان با آستازانتین و مت فورمین) نسبت به گروه کنترل(دارونما و مت فورمین) تفاوت پیدا کنند.
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Initially (before the intervention) and at the end (8 weeks after the intervention)
Initially (before the intervention) and at the end (8 weeks after the intervention)
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در ابتدا(قبل از شروع مداخله) و در انتها(8 هفته بعد از شروع مداخله)
در ابتدا(قبل از شروع مداخله) و در انتها(8 هفته بعد از شروع مداخله)
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The methods of measuring inflammatory, insulin resistance and oxidative markers variables in this study were: use of ELISA technique for interleukin-6, interleukin-1B and TNF-a and aHB using RT-PCR method for gene expression of inflammatory microRNAs including MiR-155, MiR-21, MiR-34a, using photometric method for lysoPC
The methods of measuring inflammatory, insulin resistance and oxidative markers variables in this study were: use of ELISA technique for interleukin-6, interleukin-1B and TNF-a and aHB using RT-PCR method for gene expression of inflammatory microRNAs including MiR-155, MiR-21, MiR-34a, using photometric method for lysoPC
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نحوه اندازهگیری متغیرهای شاخص های التهابی، مقاومت به انسولین و اکسیداتیو در این مطالعه عبارتند از: استفاده از تکنیک الایزا برای اینترلوکین-6، اینترلوکین-1B و TNF-aو aHB، استفاده از روش ریل تایم پی سی ار برای بیان ژن میکروRNA های التهابی شامل، MiR-155, MiR-21, MiR-34a، استفاده از روش فتومتریک برای LysoPC
نحوه اندازهگیری متغیرهای شاخص های التهابی، مقاومت به انسولین و اکسیداتیو در این مطالعه عبارتند از: استفاده از تکنیک الایزا برای اینترلوکین-6، اینترلوکین-1B و TNF-aو aHB، استفاده از روش ریل تایم پی سی ار برای بیان ژن میکروRNA های التهابی شامل، MiR-155, MiR-21, MiR-34a، استفاده از روش فتومتریک برای LysoPC
#2
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Autophagic Indexes: Following the intervention, we expect the autophagic Indexes of the patient group (treated with astaxantin and metformin) to differ from the control group (placebo and metformin)
Autophagic Indexes: Following the intervention, we expect the autophagic Indexes of the patient group (treated with astaxantin and metformin) to differ from the control group (placebo and metformin)
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شاخص های اتوفاژیک :به دنبال مداخله ای که انجام می شود انتظار داریم شاخص های اتوفاژیک گروه بیماران (تحت درمان با آستازانتین و مت فورمین) نسبت به گروه کنترل(دارونما و مت فورمین) تفاوت پیدا کنند.
شاخص های اتوفاژیک :به دنبال مداخله ای که انجام می شود انتظار داریم شاخص های اتوفاژیک گروه بیماران (تحت درمان با آستازانتین و مت فورمین) نسبت به گروه کنترل(دارونما و مت فورمین) تفاوت پیدا کنند.
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Initially (before the intervention) and at the end (8 weeks after the intervention)
Initially (before the intervention) and at the end (8 weeks after the intervention)
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در ابتدا(قبل از شروع مداخله) و در انتها(8 هفته بعد از شروع مداخله)
در ابتدا(قبل از شروع مداخله) و در انتها(8 هفته بعد از شروع مداخله)
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The method of measuring the variables of autophagic indexes in this study were: using RT-PCR technique for mTOR, Becline-1, LC3-II, western blotting method for protein level Atg-5, Atg-7
The method of measuring the variables of autophagic indexes in this study were: using RT-PCR technique for mTOR, Becline-1, LC3-II, western blotting method for protein level Atg-5, Atg-7
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نحوه اندازهگیری متغیرهای شاخص های اتوفاژیک در این مطالعه عبارتند از: استفاده از تکنیک ریل تایم پی سی ار برای mTOR, Becline-1, LC3-II، استفاده از روش وسترن بلات برای سطح پروتئینی Atg-5, Atg-7
نحوه اندازهگیری متغیرهای شاخص های اتوفاژیک در این مطالعه عبارتند از: استفاده از تکنیک ریل تایم پی سی ار برای mTOR, Becline-1, LC3-II، استفاده از روش وسترن بلات برای سطح پروتئینی Atg-5, Atg-7
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: mahtab memarpour
Full name of responsible person - Persian: مهتاب معمارپور
Street address - English: Shiraz, Zand Street, Central Building of Shiraz University of Medical Sciences, 7th Floor, Vice Chancellor for Research and Technology
Street address - Persian: شیراز،خیابان زند،ساختمان مرکزی دانشگاه علوم پزشکی شیراز،طبقه هفتم،معاونت تحقیقات و فناوری
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ۱۴۳۳۶ - ۷۱۳۴۸
Phone: +98 71 3212 2430
Fax:
Email: vcrdep@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: mahtab memarpour Full name of responsible person - Persian: مهتاب معمارپور Street address - English: Shiraz, Zand Street, Central Building of Shiraz University of Medical Sciences, 7th Floor, Vice Chancellor for Research and Technology Street address - Persian: شیراز،خیابان زند،ساختمان مرکزی دانشگاه علوم پزشکی شیراز،طبقه هفتم،معاونت تحقیقات و فناوری City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: ۱۴۳۳۶ - ۷۱۳۴۸ Phone: +98 71 3212 2430 Fax: Email: vcrdep@sums.ac.ir Web page address:
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Yes
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100
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Public
public
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Domestic
domestic
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Academic
academic
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Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
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دانشگاه علوم پزشکی شیراز
دانشگاه علوم پزشکی شیراز
Protocol summary
Study aim
Determination of the effect of astaxanthin on autophagic pathway and study of inflammatory activities by gene expression of inflammatory-related microRNAs in patients with type 2 diabetes treated with metformin
Design
The clinical trial has a control group. A double-blind, randomized study.
1. metformin is prescribed with placebo.
2. metformin is prescribed with astaxanthin.
Settings and conduct
The study population was from patients referring to Endocrine and Metabolism Research Center of Isfahan and conducted tests at the Faculty of Pharmacy of Isfahan University of Medical Sciences.
The following biochemical parameters are measured in two groups of treatment and control before and 8 weeks after treatment: blood glucose and glycosylated sugar, blood lipids, uric acid, serum creatinine, and blood urea
Evaluation of autophagic gene expression on PBMC by RT-PCR method
Expression of autophagic proteins (Atg-5, ATg-7) by Western blotting method
Evaluation of serum levels of inflammatory markers (TNF-a, IL-6, IL-1B)
Expression of inflammatory-related microRNAs (MiR-155,21,34a)
Evaluation of insulin resistance and oxidative markers (aHB, LysoPC)
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 2 diabetic patients treated by metformin
nonInclusion criteria: patients with type 1 diabetes, Pregnant women. Women in lactation, Taking any antidiabetic drug other than metformin, Patients with other endocrine disorders, Take any other antioxidant supplement
Intervention groups
One group will be taken metformin (1000-1500 mg/day) plus astaxanthin supplementation 10 mg/day and other groups will be taken metformin 1500-1000 mg/day plus astaxanthin placebo For 8 weeks
All steps for the treatment process are under the supervision of a doctor.
Main outcome variables
Increasing the efficacy of treatment in improving inflammatory, autophagic, insulin resistance and oxidative indexes
General information
Reason for update
Evaluation of the effects of astaxanthin on markers related to autophagy and study of inflammatory activity by expression of microRNAs in type ۲ diabetic patients are treated with metformin (Continued study on available samples)
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042939N1
Registration date:2019-06-17, 1398/03/27
Registration timing:registered_while_recruiting
Last update:2022-04-23, 1401/02/03
Update count:2
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
Mohamad hosein aarabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7052
Email address
mh.aarabi@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
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Actual recruitment end date
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Trial completion date
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Scientific title
Evaluation of the effects of astaxanthin on markers related to autophagy and study of inflammatory activity by expression of microRNAs in type ۲ diabetic patients are treated with metformin
Public title
Evaluating the effect of astaxanthin supplement in patients with type 2 diabetes Treated by metformin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes
Treated by metformin
Age: 20-60 years
Exclusion criteria:
Patients with type 1 diabetes
Pregnant women
Women in lactation
Taking any antidiabetic drug other than metformin
Patients with other endocrine disorders
Take any other antioxidant supplement
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Get 2 blood sample from the patient before and after the intervention
Randomization (investigator's opinion)
Randomized
Randomization description
from among patients in the Isfahan Endocrine and Metabolism Center, 50 patients with type 2 diabetes who are merely treated with metformin are selected available and easy to use.Then, the names of the patients were entered into the SPSS software and using the software, they are randomly divided into two groups of 25 intervention and placebo groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
For this purpose, based on the supplement we used in this intervention, which is the softgel, the placebo is designed and the investigator is aware of the difference between the two, but the patients and the statistical counselor do not know this difference.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of Research & Technology, Headquarters Building No. 4, Isfahan University of Medical Sciences & Health Services, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.103
2
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of Research & Technology, Headquarters Building No. 4, Isfahan University of Medical Sciences & Health Services, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.673
3
Ethics committee
Name of ethics committee
Ethics committee of shiraz University of Medical Sciences
Street address
Shiraz, Zand Street, Central Building of Shiraz University of Medical Sciences, 7th Floor, Vice Chancellor for Research and Technology, Secretariat of the Ethics committee in Research university
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2022-03-29, 1401/01/09
Ethics committee reference number
IR.SUMS.REC.1401.029
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Glycemic Indexes: Following the intervention, we expect the glycemic indexes of the patients (treated with astaxanthin and metformin) to differ from the control group (placebo and metformin).
Timepoint
Initially (before the intervention) and at the end (8 weeks after the intervention)
Method of measurement
(Glycemic indexes in this study include fasting blood sugar, glycated hemoglobin, and insulin). Fasting blood Glucose: Colorimetric Method - Glycated Hemoglobin: High Performance Liquid Chromatography - Insulin: ELISA Technique
2
Description
Oxidative stress: Following the intervention, we expect the oxidative stress markers of the patients (treated with astaxanthin and metformin) to differ from the control group (placebo and metformin).
Timepoint
Initially (before the intervention) and at the end (8 weeks after the intervention)
Method of measurement
The oxidative stress in this study is measured by markers that are: total antioxidant capacity, malondialdehyde, catalase and superoxide dismutase, all of which are measured by Spectrophotometry and with relevant reagents.
3
Description
Tubular and glomerular Indexes: Following the intervention, we expect the tubular and glomerular Indexes of the patient group (treated with astaxantin and metformin) to differ from the control group (placebo and metformin)
Timepoint
Initially (before the intervention) and at the end (8 weeks after the intervention)
Method of measurement
Tubular and glomerular markers in this study are: cystatin C, microalbumin, creatinine and lipocalin-associated neutrophil gelatinase: ELISA technique
4
Description
Oxidative stress: Following the intervention, we expect the oxidative stress markers of the patients (treated with astaxanthin and metformin) to differ from the control group (placebo and metformin)
Timepoint
Initially (before the intervention) and at the end (8 weeks after the intervention)
Method of measurement
The oxidative stress in this study is measured by markers that are:Total protein, malondialdehyde, 8-hydroxy deoxyguanosine and protein products oxididation by Bradford methods and ELISA technique
5
Description
Inflammation, insulin resistance and oxidative Indexes: Following the intervention, we expect the inflammation Indexes of the patient group (treated with astaxantin and metformin) to differ from the control group (placebo and metformin)
Timepoint
Initially (before the intervention) and at the end (8 weeks after the intervention)
Method of measurement
The methods of measuring inflammatory, insulin resistance and oxidative markers variables in this study were: use of ELISA technique for interleukin-6, interleukin-1B and TNF-a and aHB using RT-PCR method for gene expression of inflammatory microRNAs including MiR-155, MiR-21, MiR-34a, using photometric method for lysoPC
6
Description
Autophagic Indexes: Following the intervention, we expect the autophagic Indexes of the patient group (treated with astaxantin and metformin) to differ from the control group (placebo and metformin)
Timepoint
Initially (before the intervention) and at the end (8 weeks after the intervention)
Method of measurement
The method of measuring the variables of autophagic indexes in this study were: using RT-PCR technique for mTOR, Becline-1, LC3-II, western blotting method for protein level Atg-5, Atg-7
Secondary outcomes
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Intervention groups
1
Description
Control group: Metformin /Placebo treated diabetic group.
Category
Placebo
2
Description
Intervention group: Intervention group: Diabetic group treated with metformin / astaxanthin.This intervention is intended to evaluate the efficacy of treatment for diabetic patients. Based on the explanation given in the proposed text Astaxanthin (3,3'-dihydroxy-β, β'-carotene-4,4'-dione) is a natural red or orange carotenoid compound that exists in different microorganisms and seafood.The main source of food is Astaxanthin, the hematococcus pluvialis (Haematococcus pluvialis), which is a green microalgae and enters the human body by eating fish and sea animals. It has an antioxidant strength of 550 times the antioxidant value of vitamin E (32).Astaxanthin has been reported to play an important role in lipid and sugar intake, in addition to anti-inflammatory effects, and the protection of the nervous system and the cardiovascular system.Various action mechanisms have been proposed for this antioxidant such as:activation of AMPK 2. regulating the PI3K / Akt signaling path in the liver 3. Increased glucose uptake by tissues (increased insulin sensitivity).It is expected that the use of this carotenoid in combination with metformin, which is almost the same mechanism of action, can be effective in increasing the efficacy of treatment. Also, considering the role of oxidative stress in the development of chronic diabetes complications and the role of diminished glucose lowering drugs in reducing these complications including renal complications, Using this antioxidant can be taken to reduce the complications of diabetes in these patients.The subjects were divided into two equal groups and each group was divided into 25 patients.1. Metformin / placebo group: This metformin (glucophage) group is given at a dose of 1000-1500 mg / day plus one placebo daily.2. Group treated with metformin / astaxanthin: This group of metformin (glucophage) with a dose of mg / day 1000-1500 with astaxanthin with a dose of 10 mg/day is given as a softgel (WAKA TANI Astaxanthin Supplement)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Mohammadhosein Aarabi
Street address
Endocrine & metabolism Research Center, Research Center of Sedigheh Tahereh (S), Islamic Republic Square - Khorram St. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9090
Email
emrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoye Javanmard
Street address
Deputy of Research & Technology, Headquarters Building No. 4, Isfahan University of Medical Sciences & Health Services, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
2
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mahtab memarpour
Street address
Shiraz, Zand Street, Central Building of Shiraz University of Medical Sciences, 7th Floor, Vice Chancellor for Research and Technology
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Attar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Clinical Biochemistry Department, Faculty of Pharmacy & Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib st.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7048
Email
Movahedian.ahmad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadhosein Araabi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Clinical Biochemistry Department, Faculty of Pharmacy & Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib st.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7052
Email
Mh.aarabi@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadhosein Araabi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Clinical Biochemistry Department, Faculty of Pharmacy & Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib st.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7052
Email
Mh.aarabi@pharm.mui.ac.ir
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
Not applicable
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