Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Primary Purpose
Diabetes Mellitus, Lactic Acidosis
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Lactic acidosis, Contrast media, Angiography, Diabetic, Metformin
Eligibility Criteria
Inclusion Criteria:
Diabetic patients receiving metformin who were scheduled for:
- coronary angiography
- coronary angioplasty
Exclusion Criteria:
Patients who had contraindication for metformin administration, such as:
- decompensated heart failure
- severe liver disease
- severe hypoxemia
- GFR<60 mL/min per 1.73 m2
Sites / Locations
- Cardiovascular research center, Modarres hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
On-metformin
Off-metformin
Arm Description
Diabetic patients receiving contrast media without discontinuing metformin.
Diabetic patients receiving contrast media with discontinuation of metformin.
Outcomes
Primary Outcome Measures
Incidence of Lactic Acidosis
Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.
Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.
Secondary Outcome Measures
Full Information
NCT ID
NCT01873859
First Posted
June 5, 2013
Last Updated
May 16, 2014
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01873859
Brief Title
Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Official Title
Incidence of Lactic Acidosis After Coronary Angiography and Angioplasty in Diabetic Patients on Continued Metformin Therapy With Normal Renal Function.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether metformin causes lactic acidosis in diabetic patients with preserved kidney function, undergoing coronary angiography or angioplasty with new contrast media.
In other words is it necessary to discontinue metformin before these procedures, even when Iodixanol is used as contrast media, which is isosmolar agent and much more safer than urografin which was the main agent in the previous studies that were the base of present guidelines?
Detailed Description
Although metformin is not directly nephrotoxic, it has been postulated that can impair gluconeogenesis from lactate, which may lead to lactate accumulation under circumstances such as acute renal failure. In diabetic patients receiving metformin, this condition can be encountered in the setting of acute renal failure following contrast media administration, during coronary angiography i.e. contrast-induced nephropathy. As a result, it has been a part of routine clinical practice to discontinue metformin before angiography to prevent metformin-associated lactic acidosis (MALA). However, there is no general consensus regarding the incidence of MALA and evidence for such intervention is poor. On the other hand, discontinuation of metformin can be associated with detrimental effects on glycemic control and thereby may increase cardiovascular risk in diabetic patients undergoing percutaneous coronary interventions. Consequently, questions have been raised recently regarding the routine discontinuation of metformin, in low-risk patients undergoing coronary angiography.
The present study was designed to assess the role of metformin in lactate production in a group of diabetic patients with normal renal function; and to address the questions about significance of routine discontinuation of metformin in low risk patients undergoing coronary angiography.
Iodixanol will be the only contrast media in all patients, because of its low nephrotoxicity. Serum blood urea nitrogen and creatinin; as well as arterial blood gases will be evaluated prior to angiography, and repeated 24 and 48 hours after the procedure. Glomerular filtration rate (GFR) is calculated using Cockcroft-Gault formula {GFR= 0.85 (for women)}.
Contrast-induced acute kidney injury is defined as a 25-50% or 0.3-0.5 mg/dl net increase in creatinine concentration compared to the baseline values. Metformin-associated lactic acidosis (MALA) is defined as an arterial pH (potential of hydrogen)<7.35 and plasma lactate concentration >5 mmol⁄L. In the M (-) group metformin will re-started 48 hours after angiography, albeit in the absence of evidence of lactic acidosis and GFR of >60 mL/min per 1.73 m2.
A written informed consent is taken from all participants and institutional review board has already approved the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Lactic Acidosis
Keywords
Lactic acidosis, Contrast media, Angiography, Diabetic, Metformin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
On-metformin
Arm Type
Active Comparator
Arm Description
Diabetic patients receiving contrast media without discontinuing metformin.
Arm Title
Off-metformin
Arm Type
No Intervention
Arm Description
Diabetic patients receiving contrast media with discontinuation of metformin.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.
Primary Outcome Measure Information:
Title
Incidence of Lactic Acidosis
Description
Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.
Time Frame
48 hrs
Title
Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.
Time Frame
48 hours from the baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic patients receiving metformin who were scheduled for:
coronary angiography
coronary angioplasty
Exclusion Criteria:
Patients who had contraindication for metformin administration, such as:
decompensated heart failure
severe liver disease
severe hypoxemia
GFR<60 mL/min per 1.73 m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeed Alipour Parsa
Organizational Affiliation
Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular research center, Modarres hospital.
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20032157
Citation
Goergen SK, Rumbold G, Compton G, Harris C. Systematic review of current guidelines, and their evidence base, on risk of lactic acidosis after administration of contrast medium for patients receiving metformin. Radiology. 2010 Jan;254(1):261-9. doi: 10.1148/radiol.09090690.
Results Reference
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Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
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