Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Overview[ - collapse ][ - ]
| Purpose | 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? |
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| Condition | Diabetes Mellitus Lactic Acidosis |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Shahid Beheshti Medical University |
| Responsible Party | Shahid Beheshti Medical University |
| ClinicalTrials.gov Identifier | NCT01873859 |
| First Received | June 5, 2013 |
| Last Updated | January 9, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 5, 2013 |
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| Last Updated Date | January 9, 2014 |
| Start Date | May 2013 |
| Estimated Primary Completion Date | February 2014 |
| Current Primary Outcome Measures | Incidence of lactic acidosis [Time Frame: 48 hrs] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media |
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| Official Title | Incidence of Lactic Acidosis After Coronary Angiography and Angioplasty in Diabetic Patients on Continued Metformin Therapy With Normal Renal Function. |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: Metformin Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin. Other Names: Glucophage |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 160 |
| Estimated Completion Date | February 2014 |
| Estimated Primary Completion Date | February 2014 |
| 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 |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Iran, Islamic Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01873859 |
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| Other Study ID Numbers | sbcvrc-43-891128 |
| Has Data Monitoring Committee | No |
| Information Provided By | Shahid Beheshti Medical University |
| Study Sponsor | Shahid Beheshti Medical University |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Saeed Alipour Parsa Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| Cardiovascular research center, Modarres hospital. | Tehran, Iran, Islamic Republic of Contact: Morteza Safi, Head | +98 21 2208 3106 | info@sbcvrc.orgPrincipal Investigator: Saeed Alipour Parsa Recruiting |
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