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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT00942123
First received: July 16, 2009
Last updated: July 17, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Lactic Acidosis
Metformin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Estimated Enrollment: 10
Study Start Date: January 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942123

Contacts
Contact: Luciano Gattinoni, MD 0039-02-55033232 gattinon@policlinico.mi.it

Locations
Italy
Ospedale Maggiore Policlinico Recruiting
Milano, MI, Italy, 20122
Contact: Alessandro Protti, MD     0039-02-55033232     alessandro.protti@policlinico.mi.it    
Principal Investigator: Alessandro Protti, MD            
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  More Information

No publications provided

Responsible Party: Alessandro Protti, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT00942123     History of Changes
Other Study ID Numbers: 2551
Study First Received: July 16, 2009
Last Updated: July 17, 2009
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013