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Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media

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ClinicalTrials.gov Identifier: NCT01873859
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Saeed Alipour Parsa, Shahid Beheshti University of Medical Sciences

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?


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Lactic Acidosis Drug: Metformin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Incidence of Lactic Acidosis After Coronary Angiography and Angioplasty in Diabetic Patients on Continued Metformin Therapy With Normal Renal Function.
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: On-metformin
Diabetic patients receiving contrast media without discontinuing metformin.
Drug: Metformin
Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.
Other Name: Glucophage

No Intervention: Off-metformin
Diabetic patients receiving contrast media with discontinuation of metformin.



Primary Outcome Measures :
  1. Incidence of Lactic Acidosis [ Time Frame: 48 hrs ]
    Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.

  2. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873859


Locations
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Iran, Islamic Republic of
Cardiovascular research center, Modarres hospital.
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Saeed Alipour Parsa Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences

Publications:
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Responsible Party: Saeed Alipour Parsa, Alipour Parsa S., Assistant professor of cardiology, Cardiovascular Research Center, Modarres hospital, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01873859     History of Changes
Other Study ID Numbers: sbcvrc-43-891128
First Posted: June 10, 2013    Key Record Dates
Results First Posted: June 16, 2014
Last Update Posted: June 16, 2014
Last Verified: May 2014

Keywords provided by Saeed Alipour Parsa, Shahid Beheshti University of Medical Sciences:
Lactic acidosis
Contrast media
Angiography
Diabetic
Metformin

Additional relevant MeSH terms:
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Diabetes Mellitus
Acidosis
Acidosis, Lactic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acid-Base Imbalance
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs