To Study the effect of Empagliflozin on the cardiovascular biomarkers Galectin-3 and sST-2 in type 2 diabetic patients myocardial infarction with requiring primary angioplasty
Investigating the effect of Empagliflozin on Galectin-3 and sST-2 gene expression in type 2 diabetic patients with heart infarction and requiring primary angioplasty
Design
The study will be conducted as a clinical trial with a control group, randomized double-blind, phase 4 on 60 patients. Randomization will be done by random allocation rule method and sequence of even and odd codes.
Settings and conduct
Selection of patients from type 2 diabetic patients with ST elevation myocardial infarction admitted to Ayatollah Mousavi Hospital in Zanjan
Taking the initial blood sample one day before the discharge of each patient, randomly prescribing empagliflozin or placebo and the follow-up blood sample at the end of 3 months
Extracting total RNA from samples and performing Real Time PCR to check the expression of genes
Entering data into SPSS software and using paired t test and Willcoxon test
Patient, researcher and healthcare personnel are blind and aren't aware of the codes and groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Type 2 diabetic patients with ST elevation myocardial infarction (STEMI)
Non-entry criteria:
Cardiogenic shock; hypoglycemia; diabetic ketoacidosis; history of coronary artery bypass surgery; type 1 diabetes, severe liver failure; history of severe sensitivity to empagliflozin or its formulation components; severe renal failure, end-stage renal disease( ESRD) or dialysis; hypovolemia; any inflammatory disease under treatment; end stage cancer and history of any cancer; advanced heart failure
Intervention groups
Inervention: type 2 diabetic patients treated with oral drugs, receiving empagliflozin from ABIDI Pharmaceutical Company in the form of 10 mg tablets, once a day orally for 3 months
Control: type 2 diabetic patients treated with oral drugs, receiving placebo for 3 months
Main outcome variables
Cardiac biomarkers Galectin-3 and sST-2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058910N1
Registration date:2023-08-07, 1402/05/16
Registration timing:prospective
Last update:2023-08-07, 1402/05/16
Update count:0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Mahnaz Yousefi ramandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 883 3831
Email address
mahnaz.yousefi70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Study the effect of Empagliflozin on the cardiovascular biomarkers Galectin-3 and sST-2 in type 2 diabetic patients myocardial infarction with requiring primary angioplasty
Public title
To Study the effect of Empagliflozin on the cardiovascular biomarkers in diabetic patients myocardial infarction
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients (Hb A1C: 6.5-8)
Diabetes treated with oral agents
Typical chest pain during the 12 hours before presentation lasting more than 30 minutes
ST- segment elevation above 0.1 mV in two leads or more in ECG
Exclusion criteria:
Cardiogenic shock
Diabetic ketoacidosis
History of CABG
Type 1 diabetic patients
Severe liver failure
End stages cancer or history of any cancer
History of severe allergy to empagliflozin or its formulation components
Severe renal failure (eGFR <30 mL/minute/1.73 m2), end-stage renal disease (ESRD), or dialysis
Hypovolemia
Any inflammatory disease under treatment
Advanced heart failure
Hypoglycemia
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By coding the third person (collaborator), drug and placebo are divided into odd and even groups. With the random allocation rule method, a set of 30 even codes and 30 odd codes are placed in a lottery container, and the codes are randomly removed from the container without replacement, and the created sequence is recorded, and the medicine is given to the patients based on that.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. In this study, the researcher, the patient and the healthcare personnel do not know whether the patient is being treated with medicine or placebo. By coding the third person (collaborator), the drug and placebo are divided into two groups and given to the patients randomly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Siences
Street address
Professor Youssef Sobouti Blvd., Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.ZUMS.REC.1402.099
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
I21.3
ICD-10 code description
Acute transmural myocardial infarction of unspecified site
2
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Galectin-3 gene expression
Timepoint
Measurement of Galectin-3 gene expression at the beginning of the study (before intervention) and 3 months after starting empagliflozin
Method of measurement
RT-PCR
2
Description
sST2 gene expression
Timepoint
Measurement of sST2 gene expression at the beginning of the study (before intervention) and 3 months after starting empagliflozin
Method of measurement
RT-PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, 30 type 2 diabetic patients treated with oral drugs, and they will receive empagliflozin from ABIDI Pharmaceutical Company in the form of 10 mg tablets, once a day orally for 3 months.
Category
Treatment - Drugs
2
Description
Control group: In this group, 30 type 2 diabetic patients treated with oral drugs, and they will receive placebo made by ABIDI Pharmaceutical Company, once a day orally for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Mahnaz Yousefi Ramandi
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mahnaz.yousefi70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Habib Zayghami
Street address
Professor Youssef Sobouti Blvd., Zanjan University of Medical Sciences, Faculty of Medicine
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3314 0021
Email
mahnaz.yousefi70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
15
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
2
Sponsor
Name of organization / entity
Abidi Pharmaceutical Company
Full name of responsible person
Seyed Amir Razavian Ardehali
Street address
No. 72, Abidi Blvd., Kilometer 8 of Shahid Lashkari Highway
City
Tehran
Province
Tehran
Postal code
1389776363
Phone
+98 21 4452 2451
Fax
+98 21 4450 4787
Email
R_madady2000@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Abidi Pharmaceutical Company
Proportion provided by this source
10
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahnaz Yousefi Ramandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Gavazang road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 912 883 3831
Email
mahnaz.yousefi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Reza Madadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Gavazang road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 912 542 6122
Email
R_madady2000@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahnaz Yousefi Ramandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Gavazang road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 912 883 3831
Email
mahnaz.yousefi70@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol, statistical analysis plan and informed consent form will be shared with details.
When the data will become available and for how long
From the time of publication the results up to 3 months