Investigation of Metformin effect on the expression of H19, MEG3, MALAT1 and GAS5 long non-coding RNA levels in patients with type 2 diabetes: a clinical trial study
the findings from this study, along with other studies, could help identify the mechanism of another effect on metformin in type 2 diabetes, which may be contributed by altering the expression of non-coding long-term RNAs.
Design
Clinical trial without control group, before and after drug administration
Settings and conduct
Of the 35 newly diagnosed diabetic patients who referred to the Yasuj Diabetes Clinic, they were asked to take one daily dose of metformin at a dose of 1000 or 500 mg (based on their blood glucose levels) for 2 months. Before and after taking the medication Expression of genes and biochemical parameters in individuals is investigated.
Participants/Inclusion and exclusion criteria
Patients entering the study will have the following conditions:
1.Has a fasting blood glucose level of 126 mg / dl
Patients excluded from the study will have the following conditions:
1. A group of patients taking metformin or any other blood glucose lowering drugs and any other drug, such as statin, antihypertensive drugs, anti-inflammatory drugs and an ACE inhibitor.
2. A group of patients with cardiovascular disease and inflammatory diseases (such as lupus, rheumatoid arthritis, etc.)
3. A group of patients with a variety of cancers
4. Group 1 diabetic patients
5. A group of people with hyperlipidemia and hypertension
Intervention groups
The intervention group includes 35 newly diagnosed diabetic patients who receive metformin at a specified dose for 2 months and after 2 months the level of non-coding protein RNA in their blood is measured to reduce the effect of metformin on their expression to become clear.
Main outcome variables
fasting blood glucose level
RNA expression H19; MALAT1; MEG3; GAS5
Lipid Indices (Triglycerides, Total Cholesterol, HDL-C، LDL-C)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042903N1
Registration date:2019-03-17, 1397/12/26
Registration timing:retrospective
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
nasrin parvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3378 8908
Email address
nasrin.parvar@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
1398-01-20, 777/01/-58
Expected recruitment end date
1398-07-20, 781/01/-1338
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Metformin effect on the expression of H19, MEG3, MALAT1 and GAS5 long non-coding RNA levels in patients with type 2 diabetes: a clinical trial study
Public title
Effect of metformin on the expression of non-coding long-term RNA in diabetic patients.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Has a fasting blood glucose level of 126 mg / dl
Exclusion criteria:
consumer metformin or any other hypoglycemic drug and any other drug like statin, antihypertensive, anti-inflammatory drug, and an ACE inhibitor.
A group of patients with cardiovascular disease and inflammatory diseases (such as lupus, rheumatoid arthritis, etc.)
A group of patients with a variety of cancers
A group of type 2 of diabetes
Group of people with hyperlipidemia and hypertension
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
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 Yasuj University of Medical Sciences
Street address
Yasuj, Motahari Blvd, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.YUMS.REC.1397.149
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type II in people New case
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With an auto-analyzer device
2
Description
triglyceride
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With an auto-analyzer device
3
Description
Total cholesterol
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With an auto-analyzer device
4
Description
Cholesterol in low density lipoprotein
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With an auto-analyzer device
5
Description
Cholesterol in high density lipoprotein
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With an auto-analyzer device
6
Description
long non-coding RNA H19
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With Real-Time device
7
Description
long non-coding RNA MALAT1
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With Real-Time device
8
Description
long non-coding RNA MEG3
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With Real-Time device
9
Description
long non-coding RNA GAS5
Timepoint
At the beginning of the study (before the intervention) and two months after taking metformin
Method of measurement
With Real-Time device
Secondary outcomes
1
Description
Long-term non-encoding RNA expression H19
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Laboratory analysis
2
Description
Long-term non-encoding RNA expression MALAT1
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Laboratory analysis
3
Description
Long-term non-encoding RNA expression MALAT1
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Laboratory analysis
4
Description
Long-term non-encoding RNA expression GAS5
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Laboratory analysis
5
Description
Glucose
Timepoint
Before intervention and 2 months after intervention
Method of measurement
mg/dl
6
Description
HbA1c
Timepoint
After intervention
Method of measurement
Percentage
7
Description
Triglycerides
Timepoint
Before and after intervention
Method of measurement
mg\dl
8
Description
Waist
Timepoint
Before and after intervention
Method of measurement
centimeter
9
Description
Hip circumference
Timepoint
Before and after intervention
Method of measurement
centimeter
10
Description
BMI
Timepoint
Before and after intervention
Method of measurement
Kg/m2
11
Description
triglyceride
Timepoint
Before and after intervention
Method of measurement
mg/dl
12
Description
LDL
Timepoint
Before and after intervention
Method of measurement
mg/dl
13
Description
HDL
Timepoint
Before and after intervention
Method of measurement
mg/dl
14
Description
Cholesterol
Timepoint
Before and after intervention
Method of measurement
mg/dl
Intervention groups
1
Description
Since the people who are studying the New Case do not need a control group. After entering the study, these individuals receive a daily dose of metformin at a dosage of 1000 or 500 mg per day (based on their blood glucose levels) for 2 months a day.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasouj University of Medical Sciences
Full name of responsible person
ali mirzaei
Street address
Yasuj, Motahari Blvd, Yasouj University of Medical Sciences
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
mirzaee3a2003@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Yasuj, Motahari Blvd, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Ali mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Yasuj, Motahari Blvd, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
mirzaee3a2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Yasuj, Motahari Blvd, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
mirzaee3a2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
nasrin parvar
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
Yasuj, Motahari Blvd, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
nasrin.parvar@yums.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