Is the metformin dose correctly adjusted to the renal clearance of the individual DM2 patient? Is there a correlation between high metformin concentrations and biochemical parameters e.g. lactic acid in the blood?
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To gain a better insight in metformin dose and adjustments to renal clearance.
Secondary outcome
Correlation between metformin dose, renal clearance (MDRD), metformin and
lactic acid concentration in blood.
Background summary
For therapeutic treatment of diabetic patients, metformin is the preferent drug
to prescribe according to the NHG standard and international guidelines. Hence
metformin prescriptions have increased. According to dosing guidelines
metformin dose should be adjusted in case of a decrease in renal clearance
(MDRD). It is still unclear if not acting in concordance to the dosing
guidelines will lead to increased metformin concentrations. It has been
reported that a relative high concentration of metformin in the blood may cause
a lactic acidosis. To our knowledge there is no consensus on the correlation
between metformin and lactate concentrations.
Study objective
Is the metformin dose correctly adjusted to the renal clearance of the
individual DM2 patient? Is there a correlation between high metformin
concentrations and biochemical parameters e.g. lactic acid in the blood?
Study design
Prospective pilot study, in which 90 patients will enrole. These patients will
be assigned according to renal clearance (MDRD) following the matrix of the
study protocol (see below).
MDRD Metformine Bioch. Parameters HbA1c Bijwerkingen Comorbiditeit
dosering serum lactaat
(ml/min) (mg) (mmol/L)
0 - 30
30 - 60
> 60
Study burden and risks
The blood samples required for this study will be obtained by trained medical
staff during routine clinical check up. Therefore no extra burden or risk is
involved for the patients.
Lijnbaan 32
2512 VA Den Haag
Nederland
Lijnbaan 32
2512 VA Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
diagnosis of diabetes mellitus type II, treatment with metformin
Exclusion criteria
no diabetes mellitus type II, treatment without metformin, participation in other study with blinded study drug
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28316.098.09 |