Determining the effect of Metformin administration before surgeries on control of hyperglycemia
Design
Clinical trial for two parallel groups (treatment and control) blinded accidentally in the second phase for 176 patients
Settings and conduct
Surgery cases of Imam Reza Hospital of Mashhad
Participants/Inclusion and exclusion criteria
Entry requirements:
Non-diabetic patients
ASA class I, II
Candidates for orthopedic surgery hospitalized in Imam Reza (AS) Hospital in Mashhad in 1399 will be included in the project
No entry conditions:
Prohibitions of metformin use, such as acute or chronic renal failure or injury, or a candidate for diagnostic procedures requiring the administration of a contrast agent before and 5 hours after surgery.
Dissatisfaction
Allergy to metformin
Patients with ASA above grade II
Drug addicts
Uncomplicated surgical complication
Forcing to use hemodynamic support drugs at any stage of the study
Use non-general anesthesia to perform the procedure
Need re-surgical intervention in the first 24 hours
Diabetic people
Intervention groups
Intervention group: Patients receiving metformin who were given 500 mg metformin tablets at half an hour before surgery.
Control group: Includes patients who received a placebo half an hour before surgery.
Main outcome variables
Blood Suger
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111212008384N9
Registration date:2022-04-24, 1401/02/04
Registration timing:retrospective
Last update:2022-04-24, 1401/02/04
Update count:0
Registration date
2022-04-24, 1401/02/04
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2021-12-22, 1400/10/01
Trial completion date
2022-03-06, 1400/12/15
Scientific title
Investigation of the effect of administration of Metformin before surgery on controlling postoperative hyperglycemia in non-diabetic patients
Public title
Investigation of the effect of administration of Metformin before surgery on controlling postoperative hyperglycemia in non-diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non diabetic patients
ASA class I or II
Candidate for orthopedic surgery in Imam Reza Hospital of Mashhad during 1399 solar year
Ages 18 to 80 years
Exclusion criteria:
Prohibitions of metformin use, such as acute or chronic renal failure or injury, or a candidate for diagnostic procedures requiring the administration of a contrast agent before and 5 hours after surgery
Dissatisfaction
Allergy to metformin
Patients with ASA above grade II
Drug addicts
Uncomplicated surgical complication
Forcing to use hemodynamic support drugs at any stage of the study
Use non-general anesthesia to perform the procedure
Need re-surgical intervention in the first 24 hours
Diabetic people
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
176
Actual sample size reached:
176
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization has been used. In this method, 44 blocks of 4 are selected through the relevant sites. Then 88 letters A and 88 letters B were prepared. Opaque envelopes were also used for concealment. 176 envelopes were prepared and the letters A and B were placed inside the envelopes, respectively. The envelopes were sealed and given to the patient's recipient. Each patient was given an envelope (in order) at the time of referral, which the patient provided to the physician. The letter A represented the metformin group and the letter B represented the placebo group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Employees who admitted patients and recorded data did not know patients who received metformin or placebo and were unaware of how individuals were assigned to the two study groups.
Placebo
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
Department of anesthesiology, Imam Reza hospital, Shariati Square
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Approval date
2020-05-19, 1399/02/30
Ethics committee reference number
Ir.mums.medical.rec.1399.289
Health conditions studied
1
Description of health condition studied
blood suger
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
blood suger
Timepoint
after surgery then every 6 hours for 24 hours
Method of measurement
Bs glocometr
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: It consisted of 88 patients receiving one metformin tablet (Merck Sante company, France) at a dose of 500 mg half an hour before surgery orally at a time. Blood glucose, creatinine, and BUN were measured before surgery in these patients. Also, immediately after the operation, the creatinine level, BUN, was measured and blood glucose levels were measured at 6-hour intervals and up to 24 hours after the operation.
Category
Prevention
2
Description
Control group: It consisted of 88 patients who received one placebo tablet orally half an hour before surgery at a time. Blood glucose, creatinine, and BUN were measured before surgery in these patients. Also, immediately after the operation, the creatinine level, BUN, was measured and blood glucose levels were measured at 6-hour intervals and up to 24 hours after the operation (Faculty of Pharmacy, Mashhad University of Medical Sciences provided us with a similar pill to metformin without any special drug effect as a placebo).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Arash Peivandi Yazdi
Street address
Department of anesthesiology, Imam Reza hospital
City
مشهد
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
PeivandiA@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
مجید غیور مبرهن
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
مشهد
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Vice Chancellor for Research, Mashhad University of Medical Science
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
Dr. Arash Peivandi Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Imam Reza hospital
City
مشهد
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 1802 2677
Email
PeivandiA@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Imam Reza hospital
City
مشهد
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
PeivandiA@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Imam Reza hospital
City
مشهد
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
PeivandiA@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can potentially be shared after people are not identified
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
After correspondence with the scientific person in charge of the project and after the publication of the article, by preserving the intellectual rights of the authors, it is possible to access the data and perform analysis on the information.
From where data/document is obtainable
To request data, you can correspond by email to the person in charge of the scientific plan
What processes are involved for a request to access data/document
To request data, you can correspond by email to the person in charge of the scientific plan