Evaluation the effect of astaxanthin supplementation on the plasma and cellular levels of magnesium, zinc, copper and selenium in patients with type 2 diabetes treated by metformin
Evaluation the effect of astaxanthin supplementation on the plasma and cellular levels of magnesium, zinc, copper and selenium in patients with type 2 diabetes treated by metformin
Design
Clinical trial with control group and placebo group, parallel, double blind, randomized, phase 3 and study on 50 patients. SPSS software will be used to generate random numbers.
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 cellular and plasma levels of magnesium, zinc, copper and selenium are measured in two groups of treatment and control before and 8 weeks after treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 2 diabetic patients treated by metformin
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
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 placebo For 12 weeks All steps for the treatment process are under the supervision of a doctor.
Main outcome variables
Trace elements of magnesium, zinc, copper and selenium at the cellular and plasma levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042939N3
Registration date:2022-11-10, 1401/08/19
Registration timing:prospective
Last update:2022-11-10, 1401/08/19
Update count:0
Registration date
2022-11-10, 1401/08/19
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
2022-11-22, 1401/09/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of astaxanthin supplementation on the plasma and cellular levels of magnesium, zinc, copper and selenium in patients with type 2 diabetes treated by metformin
Public title
Evaluating the effect of astaxanthin supplement on the levels of trace elements in patients with type 2 diabetes treated with metformin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetesTreated by metformin
Age: 20-60 years
Exclusion criteria:
Patients with type 1 diabetes
Pregnant women
Women in lactation
Taking any anti diabetic 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
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
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
2022-08-10, 1401/05/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.181
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
Cellular levels of magnesium
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
2
Description
Cellular levels of zinc
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
3
Description
Cellular levels of copper
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
4
Description
Cellular levels of selenium
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
Secondary outcomes
1
Description
Plasma levels of magnesium
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
2
Description
Plasma levels of Zinc
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
3
Description
Plasma levels of copper
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
4
Description
Plasma levels of selenium
Timepoint
Before and at the end of intervention
Method of measurement
Atomic absorption analysis
Intervention groups
1
Description
Intervention group: Astaxanthin supplement; For 8 weeks, they will receive one 10 mg astaxanthin soft gel tablet daily.
Category
Treatment - Other
2
Description
Control group: They will receive 1 placebo tablet containing starch daily for 8 weeks.
Category
Treatment - Other
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
Gholamreza Askari
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
Mohammad Hosein 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 scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamadhosein Araabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Clinical Biochemistry, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7052
Fax
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
Mohamadhosein Araabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Clinical Biochemistry, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 7052
Fax
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