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Variation in Serum Levels of Metformin in Patients With Reduced Renal Function

Sponsor
Skane University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00767351
Collaborator
(none)
30
Enrollment
9
Duration (Months)

Study Details

Study Description

Brief Summary

Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases.

In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated.

The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.

The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function
    Study Start Date :
    Oct 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2009
    Actual Study Completion Date :
    Jul 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Patients above the age of 18 years with type 2 diabetes mellitus.

      • Reduced renal function measured as estimated GFR (below 60 ml/min/1.73).

      • Treatment with metformin on going.

      Exclusion Criteria:
      • Severely reduced GFR (< 30 ml(min/1.73)

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Skane University Hospital

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Gunnar Sterner, PhD, Skane University Hospital
      ClinicalTrials.gov Identifier:
      NCT00767351
      Other Study ID Numbers:
      • 001
      First Posted:
      Oct 7, 2008
      Last Update Posted:
      Sep 10, 2018
      Last Verified:
      Sep 1, 2018
      Additional relevant MeSH terms:
      Diabetes Mellitus, Type 2

      Study Results

      No Results Posted as of Sep 10, 2018