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A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing off-pump coronary artery bypass graft surgery

Protocol summary

Study aim
The effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing off-pump coronary artery bypass graft surgery
Design
Totally, 80 type II diabetic candidates for surgery were chosen from the Ghaem Hospital, Mashhad, Iran. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using simple and successive sampling methods.
Settings and conduct
Type II diabetic patients who are candidates for surgery at the Ghaem Hospital, Mashhad, Iran, are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 35-75 years; sustaining ASA II; blood sugar of 150-300 mg/dl; lack of simultaneous emergency surgery or heart valve surgery. Exclusion criteria: Having underlying diseases (e.g., pulmonary, liver, kidney, thyroid, and digestive diseases); having history of open-heart surgery; fever; trauma; carotid artery involvement; sensitivity to insulin glargine.
Intervention groups
The intervention group will receive 0.1 units/kg glargine insulin 2 hours before the surgery. The patients will receive regular insulin intravenously during and after the surgery and subcutaneous injection regular subcutaneous insulin injection after the surgery. The control group will receive 0.1 cc normal saline 2 hours before the surgery. Regular insulin injection will be similar to the intervention group.
Main outcome variables
Evaluation and comparison of blood glucose will be performed before the surgery, every 2 hours intraoperatively, and every 4-24 hours after the surgery in two groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130428013159N11
Registration date: 2020-03-14, 1398/12/24
Registration timing: prospective

Last update: 2020-03-14, 1398/12/24
Update count: 0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing off-pump coronary artery bypass graft surgery
Public title
Effect of glargine insulin on hyperglycemic control in type II diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 35-75 years Sustaining ASA II Blood sugar of 150-300 mg/dl Lack of a simultaneous emergency surgery or heart valve surgery.
Exclusion criteria:
Having underlying diseases (e.g., pulmonary, liver, kidney, thyroid, and digestive diseases) Having history of open-heart surgery Fever Trauma Carotid artery involvement Sensitivity to insulin glargine
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into two groups of 80 patients with www.sealedenvelope.com website. A noninvolved researcher will determine the random assignment sequencing base on block randomization. This site is designed that random assignment groups with no restriction.
Blinding (investigator's opinion)
Single blinded
Blinding description
Type II diabetic patients who are candidates for off-pump coronary artery bypass graft surgery at the Ghaem Hospital, Mashhad, Iran, are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.595

Health conditions studied

1

Description of health condition studied
type II diabetic
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Blood glucose
Timepoint
Before the surgery, every 2 hours intraoperatively, and every 4-24 hours after the surgery
Method of measurement
Glucose meter

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive 0.1 mg/kg units/kg glargine insulin 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive 0.1 cc normal saline 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Shima Sheybani provides the analysis code to the applicants via email: Sheybanish@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.
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