Our aim in this study is to evaluate the effect of Insulin Glargine on recovery of patients with Diabetic ketoacidosis. In a unicentral randomized clinical trial, 36 diabetic patients from both genders admitted to the endocrinology ward of Emam Reza Hospital, Tabriz, Iran, will receive standard treatment for ketoacidosis including intravenous infusion of Insulin Regular 0.1 units/kg until the end of ketoacidotic state or standard treatment plus Insulin Glargine 0.4 units/ kg every 24 hours subcutaneously until the end of ketoacidotic state for control and intervention groups, respectively. Main inclusion criteria are to be older than 12 years old and approved diabetic ketoacidosis. Main exclusion criteria are acute cardiac infarction; advanced kidney or liver failure; patients in need for an emergent surgery and pregnancy. Blood pH, bicarbonate and urine ketone before the initiation of the treatment and in 4 hour periods and glucose in 1 hour periods until the end of the ketoacidotic state will be measured to make comparison between the groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050713258N1
Registration date:2013-05-29, 1392/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-29, 1392/03/08
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 418 2174
Email address
hoshyarj@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-04-03, 1392/01/14
Expected recruitment end date
2013-10-06, 1392/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Insulin Glargine on recovery of patients with Diabetic Ketoacidosis
Public title
The effects of a long acting insulin on the recovery of patients with diabetic ketoacidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to be older than 12 years old; approved diabetic ketoacidosis)
Exclusion criteria: (Acute cardiac infarction; advanced kidney or liver failure; patients in need for an emergent surgery; pregnancy)
Age
From 12 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2013-04-03, 1392/01/14
Ethics committee reference number
9212
Health conditions studied
1
Description of health condition studied
Diabetic Ketoacidosis
ICD-10 code
E10-E14:1
ICD-10 code description
Diabetes mellitus with ketoacidosis
Primary outcomes
1
Description
Blood pH
Timepoint
Before the initiation of the study and in 4 hour periods until the end of the ketoacidotic state
Method of measurement
By ABG instrument
2
Description
Blood bicarbonate concentration
Timepoint
Before the initiation of the study and in 4 hour periods until the end of the ketoacidotic state
Method of measurement
In milliequivalents per liter and by ABG instrument
3
Description
Urine ketone
Timepoint
Before the initiation of the study and in 4 hour periods until the end of the ketoacidotic state
Method of measurement
By urine test tape
4
Description
Admition time
Timepoint
From admition until discharge
Method of measurement
Days
5
Description
Blood Glucose concentration
Timepoint
Before the initiation of the study and in 1-hour periods until the end of the ketoacidotic state
Method of measurement
In milligrams per deciliter and by Glucometer
Secondary outcomes
empty
Intervention groups
1
Description
For intervention group standard treatment for ketoacidosis including intravenous infusion of Insulin Regular 0.5 units/kg plus Insulin Glargine made by the Sanofi corporation 0.4 units/ kg every 24 hours subcutaneously until the end of ketoacidotic state will be administered.
Category
Treatment - Drugs
2
Description
For control group standard treatment for ketoacidosis including intravenous Insulin Regular 0.1 units/kg until the end of ketoacidotic state will be administered