Determining the effect of astaxanthin supplement on glycemic indexes and oxidative stress markers in type 2 diabetic patients treated by 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
Other tests:
Investigation of Gluconeogenesis on RBC by RT-PCR
Evaluation of cell signaling protein expression on white blood cells by western blot method
The activity of catalase, malondialdehyde, superoxide dismutase enzymes, total antioxidant capacity in serum
The activity of the sodium-potassium channel in red blood cells
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
(Age)Increasing the efficacy of treatment in improving the oxidative index of patients and serum lipid and enzyme indices of serum and signaling routes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042939N1
Registration date:2019-06-17, 1398/03/27
Registration timing:registered_while_recruiting
Last update:2019-06-17, 1398/03/27
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of astaxanthin supplement on glycemic indexes and oxidative stress markers in type 2 diabetic patients Treated by 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
empty
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
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.
Secondary outcomes
empty
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, 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
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