Investigating the effect of metformin on vascular function and cardiovascular risk factors in children and adolescents with type 1 diabetes: a randomized, double-blind clinical trial
Determining the effect of metformin on endothelial function and cardiovascular disease risk factors in children and adolescents with type 1 diabetes.
Design
A double-blind parallel clinical trial by block allocation on 52 children and adolescents with type 1 diabetes
Settings and conduct
This study is a double-blind clinical trial in children and adolescents with type 1 diabetes for 6 months. Patients who refer to Mofid Children's Hospital will be invited to participate in the study. The participants will be randomly divided into 2 groups (placebo group, group receiving metformin) and they will be asked to consume 500 mg of supplement or placebo daily. The participants and the researcher will not be aware of the type of drug or placebo received.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age 8 to 21 years
• Body mass index (BMI) percentile for ages 5 to 85
• Receiving insulin (Recombinant, NPH, Regular)
• Not using metformin in the past year
• Diagnosis of type 1 diabetes (at least 5 years)
• Not suffering from diabetic ketoacidosis or hypoglycemia (blood sugar level less than 50 mg/dL) in the last 6 months
• Not using metformin in the past year
• Not taking anti-hypertensive, anti-inflammatory, anti-coagulant, fat-reducing, weight-reducing and antioxidant drugs in the last 6 months
• Willingness to participate in the plan
Non-inclusion criteria:
• Pregnant or lactating people
• Having severe side effects of metformin
•Suffering from endocrine disorders such as hypothyroidism
• Any acute illness that leads to hospitalization of the patient
• Lack of compliance (the patient does not want to continue participating in the study for any reason)
Intervention groups
In the intervention and control groups, respectively, Metformin and placebo will be used at a dose of 500 mg twice a day for 6 months.
Main outcome variables
Flow-mediated dilatation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230930059564N1
Registration date:2023-11-20, 1402/08/29
Registration timing:prospective
Last update:2023-11-20, 1402/08/29
Update count:0
Registration date
2023-11-20, 1402/08/29
Registrant information
Name
Asieh Mosallanejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 515 0578
Email address
mosalladr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-06-18, 1403/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of metformin on vascular function and cardiovascular risk factors in children and adolescents with type 1 diabetes: a randomized, double-blind clinical trial
Public title
Investigating the effect of metformin on vascular function and cardiovascular risk factors in children and adolescents with type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 8 to 21 years
Body mass index (BMI) percentile for ages 5 to 85
Receiving insulin (Recombinant, NPH, Regular)
Not using metformin in the past year
Diagnosis of type 1 diabetes (at least 5 years)
Not suffering from diabetic ketoacidosis or hypoglycemia (blood sugar level less than 50 mg/dL) in the last 6 months
Not using metformin in the past year
Not taking anti-hypertensive, anti-inflammatory, anti-coagulant, fat-reducing, weight-reducing and antioxidant drugs in the last 6 months
Willingness to participate in the plan
Exclusion criteria:
Pregnant or lactating people
Having severe side effects of metformin (lactic acidosis, severe digestive problems)
Suffering from endocrine disorders such as hypothyroidism
Any acute illness that leads to hospitalization of the patient
Lack of compliance (the patient does not want to continue participating in the study for any reason)
Age
From 8 years old to 21 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by block allocation. The method of randomization will be such that 13 blocks of four will be considered using the software to equalize the distribution of people in two groups, and then random allocation of people in each block will be done to intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blindness, so that researchers and all participants are unaware of intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1939546311
Approval date
2023-09-22, 1402/06/31
Ethics committee reference number
IR.SBMU.MSP. REC.1402.401
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Flow-mediated dilatation
Timepoint
At the beginning of the study and at the end of 6 month
Method of measurement
Sonography
2
Description
Glycated hemoglobin A1C
Timepoint
At the beginning of the study and at the end of 6 month
Method of measurement
Elisa kit
3
Description
Triglyceride
Timepoint
At the beginning of the study and at the end of 6 month
Method of measurement
Elisa kit
4
Description
Fasting blood sauger
Timepoint
At the beginning of the study and at the end of 6 month
Method of measurement
Elisa kit
5
Description
Body mass index
Timepoint
At the beginning of the study and at the end of 6 month
Method of measurement
Calculate weight divided by height (cm) to the power of two
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving 500 mg metformin twice a day for 6 months
Category
Treatment - Drugs
2
Description
Control group: receiving 500 mg placebo twice a day for 6 months
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main implications can be shared at the end of the study.
When the data will become available and for how long
The access period will be 6 months after the results are published.
To whom data/document is available
The data from this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
6 months after the publication of the articles obtained from the data of this project, at the request of the person in charge of the project and his consent, the study data can be made available to researchers.
From where data/document is obtainable
Applicants can contact the responsible author via the following email to obtain the required data.
mosalladr@sbmu.ac.ir
What processes are involved for a request to access data/document
Applicants will be able to access the study data by sending an email to the responsible author within a maximum of one week.