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Sponsored by: |
Malmö University Hospital |
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Information provided by: | Malmö University Hospital |
ClinicalTrials.gov Identifier: | NCT00767351 |
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 |
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Diabetes Mellitus Type 2 Metformin Pharmacokinetics |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with type 2 DM followed at the out-patient department at the hospital will be asked to join the study
Inclusion Criteria:
Exclusion Criteria:
Contact: Gunnar Sterner, MD, PhD | 011768871005 | gunnar.sterner@skane.se |
Sweden | |
Malmo University Hospital | Recruiting |
Malmo, Sweden, 205 02 | |
Contact: Gunnar Sterner, MD, PhD 011768871005 gunnar.sterner@skane.se |
Responsible Party: | Dept of Nephrol ( Gunnar Sterner ) |
Study ID Numbers: | 001 |
Study First Received: | October 6, 2008 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00767351 |
Health Authority: | Sweden: Regional Ethical Review Board |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |