Comparison alteration of blood glucose level in continue against discontinue usage metformin tablet in diabetic type II patients untill morning of coronary artery graft surgery
In this study, we compare alteration of blood glucose levels in continue against discontinue usage metformin tablet untill morning of coronary artery graft ( CABG ) surgery. Inclusion criteria are all diabetic type II patients between 25 to 100 years old who candidate for elective coronary artery bypass graft surgery.
Exclusion criteria are emergency oronary artery bypass graf surgery; diabetic type I and usage metformin tablet more than 1000mg/day. The patients will be studied in two groups randomly. Numbers of patients in this study are 90. In one group, patients discontinue usage metformin tablet before the day of coronary artery graft surgery. In other group, patients continue usage metformin tablet untill morning the day of coronary artery graft surgery. In both groups, blood glucose levels will be measured during and after coronary artery graft surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092210348N2
Registration date:2014-12-13, 1393/09/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-13, 1393/09/22
Registrant information
Name
Masoud Tarbiat
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1825 1244
Email address
masoud.tarbiat@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison alteration of blood glucose level in continue against discontinue usage metformin tablet in diabetic type II patients untill morning of coronary artery graft surgery
Public title
Comparison alteration of blood glucose level in continue against discontinue usage metformin tablet in diabetic type II patients before surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All diabetic type II patients between 25 to 100 years old who candidate for elective coronary bypass graft surgery.
Exclusion criteria: Emergency coronary bypass graft surgery; diabetic type I; heart faiure (EF < 35%); treating with dipyridamle; xanthine derivatives; amiodarone; cimitidine and positive inotrope drugs; renal dysfuction (BUN> 20mg/dl or Cr > 1.5 mg/dl); Off- pump coronary bypass grafsurgery and usage metformin more than 1000mg/day.
Age
From 25 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences، Shariaty cross، Hamedan
City
Hamedan
Postal code
835125544 3
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
2888\9\35\16\پ
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
E10, E14
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Blood glucose level
Timepoint
Before and during and after surgery
Method of measurement
mg/dl
Secondary outcomes
1
Description
Blood cratenin level
Timepoint
Before and during and after surgery
Method of measurement
mg/dl
Intervention groups
1
Description
intervention: Discontinue metformin tablet one day before surgery
control: Continue metformin tablet until morning the day of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Masoud Tarbiat
Street address
Ekbatan Hospital، Taleghani Street، Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamedan University of Medical Sciences، Fahmideh Street، Hamedan
City
Hamedan
Grant name
معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
Grant code / Reference number
9109213560
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University Of Medical Sciences
Full name of responsible person
Masoud Tarbiat
Position
Fellowship of Cardiac Anesthesia، Anesthesiologist
Other areas of specialty/work
Street address
Nomber 293، West Block 22، Kashani street، Hamedan
City
Hamedan
Postal code
4144775889
Phone
+98 81 3423 2052
Fax
Email
masoudtarbiat@gmail.com
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Masoud Tarbiat
Position
Fellowship of Cardiac Anesthesia، Anesthesiologist
Other areas of specialty/work
Street address
Nomber 293، West Block 22، Kashani street، Hamedan
City
Hamedan
Postal code
4144775889
Phone
+98 81 3423 2052
Fax
Email
masoudtarbiat@gmail.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University Of Medical sciences
Full name of responsible person
Masoud Tarbiat
Position
Fellowship of Cardiac Anesthesia، Anesthesiologist
Other areas of specialty/work
Street address
Nomber 293، West Block 22، Kashani street، Hamedan
City
Hamedan
Postal code
4144775889
Phone
+98 81 3423 2052
Fax
Email
masoudtarbiat@gmail.com
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)