Study On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis
On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 16, 2009
CompletedFirst Posted
Study publicly available on registry
July 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedSeptember 27, 2013
September 1, 2013
1.9 years
July 16, 2009
September 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Platelet mitochondrial respiratory chain enzyme activity
Within 48 hours from admission to ICU
Eligibility Criteria
Patients with lactic acidosis and metformin intoxication (as documented by drug serum measurement)
You may qualify if:
- Lactic acidosis (pH \< 7.35 or base deficit \> 5 mmol/L and lactate \> 5 mmol/L)
- Metformin intoxication (serum drug level \> 4 mcg/mL)
- Absence of evidence of any other condition that could primarily explain the lactic acidosis
You may not qualify if:
- Less than 18 years of age
- Hemoglobin \< 8 g/dL (10 g/dL if ischemic cardiac disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Maggiore Policlinico
Milan, MI, 20122, Italy
Related Publications (1)
Protti A, Lecchi A, Fortunato F, Artoni A, Greppi N, Vecchio S, Fagiolari G, Moggio M, Comi GP, Mistraletti G, Lanticina B, Faraldi L, Gattinoni L. Metformin overdose causes platelet mitochondrial dysfunction in humans. Crit Care. 2012 Oct 3;16(5):R180. doi: 10.1186/cc11663.
PMID: 23034133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2009
First Posted
July 20, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2010
Study Completion
October 1, 2011
Last Updated
September 27, 2013
Record last verified: 2013-09