Comparison the effectiveness of basal-plus and basal-bolus regimens in patients with type 2 diabetes
Design
A clinical trial with two parallel intervention groups, not blinded, randomized
Settings and conduct
Participants are people with type 2 diabetes who referred to one of the following centers: Diabete Research Center, Khatam al-Anbia Clinic and Imam Ali Clinic in Yazd.
Among patients who meet inclusion and exclusion criteria, there were 80 samples selected based on G Power statistical formula and randomly divided into 2 equal groups.
All variables were measured in both groups before the onset of insulin regimens.
Subsequently,one group was treated by Basal-plus regimen and the other by Basal-bolous for 3 months.
Finally after the end of treatment, all variables were again measured in both groups and the effect of these regimens were determined by the improvement of 3 variables; Fasting Blood Sugar(FBS), two hour postprandial(2hpp), Hemoglobin A1c (HbA1c).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients whom their blood glucose level is not controlled by eatable drugs and we decided to begin insulin therapy; patients with HBA1c more than 8.5.
Exclusion criteria: Patients who use glucocorticoids; patients with liver dysfunction and renal dysfunction(Creatinine more than 3); patients with history of diabetic ketoacidosis; pregnant women ; mental retard patients who are not able to assent.
Intervention groups
The total population of the study were randomly divided into two equal groups and formed intervention groups.Subsequently,one group was treated by Basal-plus regimen and the other by Basal-bolous for 3 months.
Main outcome variables
Fasting blood sugar; Two hour postprandial glucose; Hemoglobin A1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140819018858N8
Registration date:2018-11-16, 1397/08/25
Registration timing:retrospective
Last update:2018-11-16, 1397/08/25
Update count:0
Registration date
2018-11-16, 1397/08/25
Registrant information
Name
Masoud Rahmanian
Name of organization / entity
Diabet Research Center, Yazd Shahid Sadughi University Of Mdical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 1728 0215
Email address
rahmanian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Yazd University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2017-08-02, 1396/05/11
Trial completion date
2017-11-02, 1396/08/11
Scientific title
Comparison the effectiveness of basal-plus and basal-bolus regimens in patients with type 2 diabetes
Public title
Comparison the effect of two different insulin regimens in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whom their blood glucose level is not controlled by eatable drugs and we decided to begin insulin therapy
Patients with HBA1C> 8.5
Exclusion criteria:
Patients who use glucocorticoids
Patients with liver disease and renal dysfunction (Cr>3)
Patients with positive history of diabetic ketoacidosis
Patients who are pregnant
Mental retard patients who are not able to assent
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
randomized block design: four in block size in intervention groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Science
First of study, one month, two months and three months after starting Insulin regimen
Method of measurement
By checking blood samples of the patients
2
Description
Fasting blood sugar
Timepoint
First of study, one month, two months and three months after starting Insulin regimen
Method of measurement
By checking blood samples of the patients
3
Description
Hemoglobin A1c
Timepoint
First of study, one month, two months and three months after starting Insulin regimen
Method of measurement
By checking blood samples of the patients
Secondary outcomes
empty
Intervention groups
1
Description
In basal bolus regimen we add prandial insulin before every three major meals in a day, this regimen continues for three months and the insulin units are decided based on every patient's first FBS and 2hpp.
Category
Treatment - Drugs
2
Description
In basal plus regimen we add prandial insulin before the major meal in a day, this regimen continues for three months and the insulin units are decided based on every patient's first FBS and 2hpp.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabete Research Center
Full name of responsible person
Samaneh Jam
Street address
Talar Honar alley, Bahonar square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Email
drc@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Yazd Imam Ali clinic
Full name of responsible person
Fatemeh Bidmeshki
Street address
Imam Ali clinic, Navab Safavi boulevard, Yazd, Iran