NCT01873859

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 16, 2014

Completed
Last Updated

June 16, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

June 5, 2013

Results QC Date

March 31, 2014

Last Update Submit

May 16, 2014

Conditions

Diabetes MellitusLactic Acidosis

Keywords

Lactic acidosisContrast mediaAngiographyDiabeticMetformin

Outcome Measures

Primary Outcomes (2)

  • Incidence of Lactic Acidosis

    Metformin-associated lactic acidosis (MALA) was defined as an arterial pH \<7.35 and plasma lactate concentration \>5 mmol ⁄ L.

    48 hrs

  • Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.

    48 hours from the baseline

Study Arms (2)

On-metformin

ACTIVE COMPARATOR

Diabetic patients receiving contrast media without discontinuing metformin.

Drug: Metformin

Off-metformin

NO INTERVENTION

Diabetic patients receiving contrast media with discontinuation of metformin.

Interventions

MetforminDRUG

Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.

Also known as: Glucophage
On-metformin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients receiving metformin who were scheduled for:
  • coronary angiography
  • coronary angioplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular research center, Modarres hospital.

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • 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.

    PMID: 20032157BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusAcidosis, Lactic

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAcidosisAcid-Base Imbalance

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Limitations and Caveats

unable to follow patient's creatinine and acidosis for more than 48 hr.

Results Point of Contact

Title
Dr. Saeed Alipour Parsa, director of clinical trial
Organization
Cardiovascular research center, Shahid Beheshti University of Medical Sciences
s_alipour@sbmu.ac.ir
+9821 2208 3106

Study Officials

  • Saeed Alipour Parsa

    Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alipour Parsa S., Assistant professor of cardiology, Cardiovascular Research Center, Modarres hospital

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 10, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 16, 2014

Results First Posted

June 16, 2014

Record last verified: 2014-05

Locations

IR(1)