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Study On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis

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ClinicalTrials.gov Identifier: NCT00942123
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:

Metformin is the first line drug of choice for the treatment of type II diabetes. Lactic acidosis can develop as a side effect, especially when renal failure leads to drug accumulation. Lactic acidosis is usually attributed to an abnormal inhibition of hepatic lactate clearance.

Growing evidence suggest that metformin can dose-dependently inhibit hepatocyte mitochondrial function. Whether a similar effect occurs in extra-hepatic human tissues remains unknown.

The investigators hypothesize that mitochondrial dysfunction occurs during metformin intoxication even in tissues other than the liver, thus contributing to the development of lactic acidosis. The aim of this study is to investigate mitochondrial integrity in circulating platelets of patients with lactic acidosis due to metformin intoxication.


Condition or disease
Lactic Acidosis Metformin

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources




Primary Outcome Measures :
  1. Platelet mitochondrial respiratory chain enzyme activity [ Time Frame: Within 48 hours from admission to ICU ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with lactic acidosis and metformin intoxication (as documented by drug serum measurement)
Criteria

Inclusion Criteria:

  1. Lactic acidosis (pH < 7.35 or base deficit > 5 mmol/L and lactate > 5 mmol/L)
  2. Metformin intoxication (serum drug level > 4 mcg/mL)
  3. Absence of evidence of any other condition that could primarily explain the lactic acidosis

Exclusion Criteria:

  1. Less than 18 years of age
  2. Hemoglobin < 8 g/dL (10 g/dL if ischemic cardiac disease)

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): NCT00942123


Locations
Italy
Ospedale Maggiore Policlinico
Milano, MI, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT00942123     History of Changes
Other Study ID Numbers: 2551
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Acidosis
Acidosis, Lactic
Acid-Base Imbalance
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs