Objectives: investigation the effect of metformin as an adjunct therapy in adolescents with poorly controlled type 1 diabetes. Design: a quasi-experimental (an uncontrolled before and after) study, sample size 29patients, single center in endocrine clinic in Children's Medical Center, without blinding, without randomization. Intervention: Metformin tablet is added to patient’s insulin therapy for 12months. Inclusion criteria: Age >10; Duration of type 1 diabetes (T1DM) >1 year; Insulin dosage>1u/kg/d; HbA1C>8% (relative control). Exclusion criteria: Nephropathies; Retinopathies; Occurrence of diabetic ketoacidocis (DKA) more than twice per year; acute hypoglycemia with loss of consciousness to a level necessitating help more than twice per year; Liver diseases or other underlying diseases. The outcome variables included Hemoglobin A1c protein, Serum creatinine, and lactate and lipid level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120110988N5
Registration date:2016-12-06, 1395/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-06, 1395/09/16
Registrant information
Name
Fatemeh Sayarifard
Name of organization / entity
Tehran University of Medical Sciences,children medical center
Country
Iran (Islamic Republic of)
Phone
00982166935848-00982161475
Email address
f-sayarifard@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-12-11, 1393/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of metformin as an adjunct therapy in adolescents with Type 1 Diabetes
Public title
Metformin as an adjunct therapy in type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included Age >10; Duration of type 1 diabetes (T1DM) >1 year; Insulin dosage>1u/kg/d; HbA1C>8% (relative control). Exclusion criteria included Nephropathies; Retinopathies; Occurrence of diabetic ketoacidocis (DKA) more than twice per year; Acute hypoglycemia with loss of consciousness to a level necessitating help more than twice per year; Liver diseases or other underlying diseases
Age
From 10 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
29
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-03-09, 1392/12/18
Ethics committee reference number
IR.TUMS.REC.1395.2894
Health conditions studied
1
Description of health condition studied
Diabetes 1
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HbA1C
Timepoint
Before the intervention and repeated with 3 months intervals till the end of study (12 months)
Method of measurement
Laboratory
2
Description
Serum creatinine
Timepoint
Before the intervention and at the end of the study (12 months)
Method of measurement
Laboratory
3
Description
Serum lactate
Timepoint
Before the intervention and at the end of the study (12 months)
Method of measurement
Laboratory
4
Description
Serum lipids
Timepoint
Before the intervention and at the end of the study (12 months)
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
metformin tablet (MINOO-METFORMIN 500MG TAB) was added to patient’s insulin therapy with the following dosages:
- weight < 50 kg: starting with 500 mg/day and then increasing gradually to 1000 mg/day
- 50 kg<weight<75 kg: starting with 500 mg/day and then increasing gradually to 1500 mg/day
- Weight>75kg: starting with 500 mg/day and then increasing gradually to 2000 mg/day
The above dosages were prescribed in three equally divided doses along with meals. Metformin was administered for 12 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center, Tehran University of Medical Sciences
Full name of responsible person
Abdollah Didban
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aria Setoodeh
Position
Associate Professor
Other areas of specialty/work
Street address
Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 61475
Fax
Email
setoodeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aria Setoodeh
Position
Associate Professor
Other areas of specialty/work
Street address
Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 61475
Fax
Email
setoodeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sayarifard
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 61475
Fax
Email
f-sayarifard@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)