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IRCT20190305042939N1 IRCT 2019-06-17 Esfahan University of Medical Sciences Evaluating the effect of astaxanthin supplement in patients with type 2 diabetes 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 2019-05-21 anticipated 50 Complete https://irct.ir/trial/38086 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Type 2 Diabetes. Intervention 1: Control group: Metformin /Placebo treated diabetic group. Intervention 2: 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). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the necessity or lack of necessity of disseminating patient data in the publication of the relevant article, the final decision will be made subsequently.
public Ahmad Movahedian Attar
Clinical Biochemistry Department, Faculty of Pharmacy & Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib st.
Isfahan Iran (Islamic Republic of) 8174673441 +98 31 3792 7048 Movahedian.ahmad@gmail.com Esfahan University of Medical Sciences scientific Mohammadhosein Araabi
Clinical Biochemistry Department, Faculty of Pharmacy & Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib st.
Isfahan Iran (Islamic Republic of) 8174673441 +98 31 3792 7052 Mh.aarabi@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with type 2 diabetes Treated by metformin Age: 20-60 years 20 years 60 years Both 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 E11 Type 2 diabetes mellitus Placebo Treatment - Drugs Control group: Metformin /Placebo treated diabetic group. 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) 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. 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. 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. 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. 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. 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. Shiraz University of Medical Sciences Esfahan University of Medical Sciences Shiraz University of Medical Sciences Approved 2019-05-18 Ethics committee of Isfahan University of Medical Sciences Deputy of Research & Technology, Headquarters Building No. 4, Isfahan University of Medical Sciences & Health Services, Isfahan Isfahan Isfehan Iran (Islamic Republic of) Approved 2021-01-06 Ethics committee of Isfahan University of Medical Sciences Deputy of Research & Technology, Headquarters Building No. 4, Isfahan University of Medical Sciences & Health Services, Isfahan Isfahan Isfehan Iran (Islamic Republic of) Approved 2022-03-29 Ethics committee of shiraz University of Medical Sciences 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 Shiraz Fars Iran (Islamic Republic of)