1. Home
  2. Approved trials
  3. » فارسی

Cardioprotective Effect of Metformin on the level of micro RNAs, mir-222, mir-195, mir-21a, in type 1 diabetes patients

Protocol summary

Study aim
Cardioprotective Effect of Metformin on the level of micro RNAs, mir-222, mir-195, mir-21a, in type 1 diabetes patients
Design
A randomized controlled clinical trial with a group of 28 patients, enrolled between May 2020 and February 2012, and followed for three months
Settings and conduct
Patients who are referred to Loghman Hospital Endocrinology Clinic will be informed if they are eligible for inclusion. Initially, the number of patients is twice the sample size. Blood samples are taken and medication begins; patients are contacted weekly and questions about regular drug use and possible side effects. Patients get free visits every month. In case of complications or exclusion criteria, the patient will be excluded. After 3 months of taking the drug, blood samples are taken again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 19 to 45 years; 5 years after onset of diabetes; insulin treatment; patient's blood glucose control for the past three months; HbA1c between 6.5 to 7.5%; no cardiovascular disease; informed consent Exclusion criteria: pregnancy or pregnancy intent in the near future; renal failure (creatinine greater than or equal to 1.3); history of intraocular injection; history of cardiovascular disease
Intervention groups
In all patients, plasma levels of the three microRNAs miR-222, miR-195, miR-21a will have measured by PCR, then patients will be treated with metformin at a dose of 500 mg daily for a week. It will reach 2 g daily and then for 12 weeks with adjusted insulin dose and blood glucose monitoring daily, metformin treatment with 2 g daily will continue, then plasma microRNA levels will be measured again
Main outcome variables
Change in the level of miR-222 after metformin; change in the level of miR-21a after metformin; change in the level of miR-195 after metformin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200217046520N1
Registration date: 2020-03-19, 1398/12/29
Registration timing: prospective

Last update: 2020-03-19, 1398/12/29
Update count: 0
Registration date
2020-03-19, 1398/12/29
Registrant information
Name
Mina Moghtaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 0065
Email address
minamoghtaderi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cardioprotective Effect of Metformin on the level of micro RNAs, mir-222, mir-195, mir-21a, in type 1 diabetes patients
Public title
Cardioprotective Effect of Metformin on the level of micro RNAs, mir-222, mir-195, mir-21a, in type 1 diabetes patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age 19 to 45 years insulin-treated for the past three months the patient's blood sugar has been controlled HbA1c ranged from 6/5 to 7/5 lack of cardiovascular disease it's been 5 years since diabetes informed consent
Exclusion criteria:
pregnancy or pregnancy intent in the near future Kidney failure (creatinine equal to or greater than 1/3) history of cardiovascular disease history of intraocular injection Glycated haemoglobin greater than 7/5
Age
From 19 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Koodakyar St. Danshjoo Blv, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.SBMU.MSP.REC.1398.042

Health conditions studied

1

Description of health condition studied
Type 1 diabetes
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Cardiovascular disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma levels of micro RNA 222 before and after metformin administration
Timepoint
Plasma level of micro RNA 222 at baseline and 12 weeks after metformin administration
Method of measurement
blood test

2

Description
Plasma levels of micro RNA 195 before and after metformin administration
Timepoint
Plasma level of micro RNA 195 at baseline and 12 weeks after metformin administration
Method of measurement
blood test

3

Description
Plasma levels of micro RNA 21a before and after metformin administration
Timepoint
Plasma level of micro RNA 21a at baseline and 12 weeks after metformin administration
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 28 Patients 19-45 years old with type 1 diabetes referred to Loghman Hospital Endocrine Clinic. Plasma levels of miR-222, miR-195, miR-21a are first measured, then patients will be treated with metformin for 12 weeks, and then the plasma levels of the above microRNAs will be measured again. SPSS software version 24 is used and paired t-test will be used. P <0.05 was considered as the level of statistical significance
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Clinic of Loghman Hakim Hospital
Full name of responsible person
Mina Moghtaderi
Street address
Loghman Hakim Hospital, Makhsoos St, South Karegar Ave
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
School of Medicine, Koodakyar St. Danshjoo Blv, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 23871
Email
Dean.medicalschool@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Moghtaderi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Alzahra Dormitory, Niyayesh Pardis, East Niyayesh Highway
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8877 0065
Fax
Email
Minamoghtaderi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Moghtaderi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Alzahra Dormitory, Niyayesh Pardis, East Niyayesh Highway
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8877 0065
Fax
Email
Minamoghtaderi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Moghtaderi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Alzahra Dormitory, Niyayesh Pardis, East Niyayesh Highway
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8877 0065
Fax
Email
Minamoghtaderi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...