Effects of metformin companionship on insulin dosage and HbA1c in adolescents
Design
Two arm parallel group randomized computer-based after they met inclusion criteria. First arm will get "metformin" added to their daily diet; second arm will continue their daily routine regimen with Insulin injection.
Settings and conduct
Fifty adolescents between 10 and 20 years old which referred to Mofid childrens hospital, Tehran, Iran with diabetes type 1 will divide into equal groups. At the beginning of study and then every 3 months, HbA1c and Insulin dosage will measure in each groups. Study is double blind; patients and physicians do not notice exact medications, but only researcher examine drug consumption and blood glucose routinely.
Participants/Inclusion and exclusion criteria
Diabetic type 1; adolescents between 10 and 20 years old; under multiple daily insulin injections for at least 1 years, without any underlying diseases except diabetes type 1.
Intervention groups
Patients will take 500 mg of metformin every 12 hours.
Main outcome variables
HbA1c changes and insulin injection dosage in each groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201207049638N1
Registration date:2020-12-19, 1399/09/29
Registration timing:retrospective
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Hedyeh Saneifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 1399
Email address
h.saneifard@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
2020-01-30, 1398/11/10
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-12-05, 1399/09/15
Scientific title
The Effect of Metformin Accompanied by Insulin on weight and insulin dosage in diabetic type 1 adolescents
Public title
Effect of Metformin in control of Diabetes type 1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 10 to 20 years old
Duration of Type 1DM more than one year
Insulin dosage more than one unit/ kg /day
Multiple daily insulin injections from at least 1 year ago
HbA1c more than 8% in the past 6 months
Exclusion criteria:
Nephropathy
Proliferative retinopathy
Diabetic ketoacidosis more than twice a year
Recurrent severe hypoglycemia
Current insulin therapy by conventional method (NPH plus Reg)
Renal or hepatic dysfunction
Age
From 10 years old to 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization made by an application "Randomizer" and was totally computer-based. Patients divided into two groups randomly and equally.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and physician was not notified about prescribed drug (metformin) and only researcher was notified about studied groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, School of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti Medical School, Daneshjoo Blvd., Yaman Ave., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1967853916
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.SBMU.MSP.REC.1398.869
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus Type 1
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications
Primary outcomes
1
Description
HbA1C concentration alteration after metformin consumption
Timepoint
Before intervention, 3 months, 6 months, and 9 months after intervention
Method of measurement
Blood test
2
Description
Creatinine concentration alteration after metformin consumption
Timepoint
Before intervention, 3 months, 6 months, and 9 months after intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: patients who were under multiple daily insulin injection. dosage is based on patients weight. Basal insulin: Lantus insulin by Sanofi 100U/ml, Bolus Insulin: Novorapid insulin by Novorapid 100U/ml
Category
Treatment - Drugs
2
Description
Intervention group: patients who were under multiple daily insulin injection like control group, 500 mg metformin, every 12 hours, added to their medication for 9 months. Metformin tablets by Abidi company.