Protocol summary
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Study aim
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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
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Design
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The clinical trial has a control group. A double-blind, randomized study.
1. metformin is prescribed with placebo.
2. metformin is prescribed with astaxanthin.
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Settings and conduct
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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)
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Increasing the efficacy of treatment in improving inflammatory, autophagic, insulin resistance and oxidative indexes
General information
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Reason for update
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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)
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Acronym
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IRCT registration information
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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
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Registration date
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2019-06-17, 1398/03/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-21, 1398/02/31
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Expected recruitment end date
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2019-09-22, 1398/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluating the effect of astaxanthin supplement in patients with type 2 diabetes Treated by metformin
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-18, 1398/02/28
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1398.103
2
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Ethics committee
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Approval date
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2021-01-06, 1399/10/17
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1399.673
3
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Ethics committee
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Approval date
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2022-03-29, 1401/01/09
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Ethics committee reference number
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IR.SUMS.REC.1401.029
Health conditions studied
1
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Description of health condition studied
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Type 2 Diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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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).
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Timepoint
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Initially (before the intervention) and at the end (8 weeks after the intervention)
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Method of measurement
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(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
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Description
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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).
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Timepoint
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Initially (before the intervention) and at the end (8 weeks after the intervention)
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Method of measurement
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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
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Description
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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)
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Timepoint
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Initially (before the intervention) and at the end (8 weeks after the intervention)
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Method of measurement
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Tubular and glomerular markers in this study are: cystatin C, microalbumin, creatinine and lipocalin-associated neutrophil gelatinase: ELISA technique
4
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Description
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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)
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Timepoint
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Initially (before the intervention) and at the end (8 weeks after the intervention)
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Method of measurement
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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
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Description
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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)
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Timepoint
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Initially (before the intervention) and at the end (8 weeks after the intervention)
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Method of measurement
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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
6
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Description
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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)
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Timepoint
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Initially (before the intervention) and at the end (8 weeks after the intervention)
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Method of measurement
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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
Intervention groups
1
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Description
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Control group: Metformin /Placebo treated diabetic group.
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Category
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Placebo
2
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Description
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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)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable