Comparison of the effect of oral magnesium supplementation and placebo on cardio metabolic markers in prediabetes subjects: a randomized, double blinded clinical trial
Effect of oral magnesium supplementation on cardio metabolic markers in people with prediabetes
Design
Two arm parallel groups (Case and Control) randomised trial, consisting of 70 patients with blinded postoperative care and outcome assessment.
Settings and conduct
This study was performed on patients referring to Endocrine and Metabolism Research Center affiliated to Isfahan University of Medical Sciences. A questionnaire is given to selected subjects who have entry criteria.
Before the intervention, a blood sample is taken from the patient and sent to the laboratory of the center. The patients' anthropometric indices data is also collected. The findings and results of the test are recorded in the patient file and archived with the questionnaire.
Patients are randomly distribute in two groups of oral magnesium and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Prediabetes condition; Age >18 and <65; Serum magnesium level <= 2mg/dL; GFR>60mL/min; Blood Pressure lower than 140/90 mmHg.
Non-inclusion criteria:
smoking; Chronic Diarrhea; Consume diuretics; Pregnancy; Liver diseases; Chronic diseases; Consume magnesium supplements in last 6 months.
Intervention groups
Intervention group: 320 mg elemental magnesium pill, daily, for 12 weeks.
Control group: Placebo daily for 12 weeks
Comparison of the effect of oral magnesium supplementation and placebo on cardio metabolic markers in prediabetes subjects: a randomized, double blinded clinical trial
Public title
Effect of oral magnesium supplementation on cardio metabolic markers in people at risk of diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
prediabetes condition
not consuming magnesium supplements in last 6 months and serum magnesium level less than 2mg/dL
GFR > 60mL/min
Blood pressure less than 140 / 90 mmHg
Permuted block randomization with blocks of size 2
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind approach will be used and both investigator and participants are blinded regarding the treatments
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
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.MUI.MED.REC.1397.252
Health conditions studied
1
Description of health condition studied
Prediabetes
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
Day 0 and day 120
Method of measurement
Lab test
2
Description
HbA1c
Timepoint
Day 0 and 120
Method of measurement
Lab test
3
Description
Lipid profile
Timepoint
Day 0 and 120
Method of measurement
Lab test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To these patients, oral magnesium tablets (320 mg) are given daily for a period of twelve weeks. The magnesium pill is the product of the Jalinus Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: To these patients, placebo tablets are given daily for twelve weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Leila Mirzaei
Street address
Khorram street, Jomhori Eslami sq.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7664
Email
info@emrc.mui.ac.ir
Web page address
http://emrc.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ashraf Aminorroaya
Street address
Hezar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7664
Email
aminorroaya@med.mui.ac.ir
Web page address
http://emrc.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
Golshan Taghipour Borujeni
Position
Subspecialist Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
g.taghipour@resident.mui.ac.ir
Web page address
http://mui.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Golshan Taghipour Borujeni
Position
Subspecialist Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
g.taghipour@resident.mui.ac.ir
Web page address
http://mui.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Golshan Taghipour Borujeni
Position
Subspecialist Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
g.taghipour@resident.mui.ac.ir
Web page address
http://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
Undecided - It is not yet known if there will be a plan to make this available
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available