Comparison of the efficacy of two treatment regimens of metformin and insulin therapy for diabetes on results of glucose tolerance test after delivery in women with gestational diabetes
Comparing of the effects of two regimens of metformin and insulin therapy on the results of postpartum glucose tolerance test in pregnant women with gestational diabetes mellitus
Design
Clinical trial, double blinded, randomized, parallel, with 60 patients
Settings and conduct
In this study, all pregnant women with a diagnosis of gestational diabetes who are referred to the midwifery clinic of Sayyad Shirazi hospital in Gorgan in order to continue their post-natal care will be considered as a statistical society, among which A randomized sample of 60 pregnant mothers with inclusion criteria and without exclusion will be included in the study
Participants/Inclusion and exclusion criteria
Criteria for inclusion:
Includes single-pregnancy
Gestational age 20 to 34 weeks
Diet and exercise tratment for at least a week without blood sugar control
absence of risk factors for lactic acidosis and absence of anatomical and chromosomal anomalies.
FBS more than 126 mg / dL , HbA1C levels greater than 6.5%
exclusion criteria:
Diagnosis of pre-pregnancy diabetes,
Dissatisfied to cooperate in the study,
presence of metabolic disorders in the patient
Need to change treatment from metformin to insulin during the study
Intervention groups
1) Insulin treatment group
2) Metformin treatment group
Main outcome variables
results of glucose tolerance test after delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038196N5
Registration date:2018-07-31, 1397/05/09
Registration timing:retrospective
Last update:2018-07-31, 1397/05/09
Update count:0
Registration date
2018-07-31, 1397/05/09
Registrant information
Name
Amir Hossein Salimi Kordasiabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 361 5549
Email address
hosseininejad.s.mohsen@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
2018-05-31, 1397/03/10
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
empty
Scientific title
Comparison of the efficacy of two treatment regimens of metformin and insulin therapy for diabetes on results of glucose tolerance test after delivery in women with gestational diabetes
Public title
Comparison of the effect of two regimens of metformin and insulin on results of postpartum glucose tolerance test
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy pregnancy
Gestational age 20 to 34 weeks
Diet and exercise treatment for at least a week without blood glucose control
absence of risk factors for lactic acidosis and the absence of anatomical and chromosomal abnormalities
fasting blood sugar greater than or equal to 126 mg / dl , HbA1C levels greater than 6.5%
Exclusion criteria:
Diagnosis of pre-pregnancy diabetes, presence of metabolic disorders in the patient
Need to start treatment with insulin in oral treatment patients
The lower limit of fasting glucose is 92 mg / dL and glucose levels will start for insulin patients two hours after meals, if treatment with metformin is higher than 120.
Dissatisfied to cooperate in the study
metabolic disorder in the patient
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked random allocation method will be used. Thus, for example, a type of treatment is given to the first block and the other to the second, and again to the first block to the third block, and so on.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind, so that the patient and the person providing the medication to the patient and the person analyzing the data do not know the type of treatment used for each person.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of gorgan University of Medical Sciences
Street address
Golestan university of medical science ,Beginin of Shastkola Street, 5th Kilometers of Gorgan Sari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.Gomus.REC.1397.028
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
Control of serum glucose level in pregnant women with gestational diabetes mellitus
Timepoint
4 days and 6 weeks after delivery
Method of measurement
Oral Glucose Tolerance Test and HbA1C Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1: Insulin therapy
Category
Treatment - Drugs
2
Description
Intervention group: Group 2: Treatment with metformin