To investigate the accuracy of non-fasting lipid profiles versus fasting lipid profiles when lipid lowering therapy is aimed at recommended lipid treatment targets.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-The number of patients that reach the set treatment target of LDL-C <2.5
mmol/l when using non-fasting blood samples while their fasting LDL
is>2.5mmol/l.
Secondary outcome
The number of patients that reach the set treatment target of apo B <0.8 g/l
when using non-fasting blood samples and do not reach the target in fasting
blood samples.
The number of patients who reach the set treatment target of
non-HDL-C<3.3mmol/l when using non-fasting blood samples and do not reach the
target in fasting blood samples.
Differences in morning and afternoon LDL-C levels.
Absolute differences in fasting and non-fasting LDL-C, direct LDL-C, apo B,
non-HDL-C and triglycerides.
Absolute differences between calculated LDL-C, direct LDL-C and LDL-C using
ultracentrifuge.
Background summary
Current guidelines recommend to measure the lipid profile in the fasting state
although evidence is growing that a non-fasting lipid profile is sufficient
most of the time and more convenient for both physicians and patients. However,
comparisons between the absolute difference in fasting and non-fasting lipid
profiles within individuals is lacking. Therefore, it is unknown whether
current lipid treatment targets are suitable when using non-fasting lipid
profiles.
Study objective
To investigate the accuracy of non-fasting lipid profiles versus fasting lipid
profiles when lipid lowering therapy is aimed at recommended lipid treatment
targets.
Study design
Open randomized, cross-over trial where subjects are randomized between first
measuring a fasting lipid profile followed by a non-fasting lipid profile on a
separate day or vice versa.
Study burden and risks
No major risks are involved besides a hematoma from the venipunctures or
hypoglycemia due to fasting. Subjects need to visit the hospital two times,
once fasting and, on another day, any time the subjects wish. Subjects receive
an expense allowance of 10 euro*s upon participation. The potential benefit of
the study is to demonstrate that a non-fasting lipid profile is accurate enough
in comparison to a fasting lipid profile, which will ease the measurement of
lipid levels for a large patient population worldwide.
Albert Schweitzerplaats 25
Dordrecht 3318 AT
NL
Albert Schweitzerplaats 25
Dordrecht 3318 AT
NL
Listed location countries
Age
Inclusion criteria
Male and female patients, aged 18 years or older, from the outpatient department of Cardiology and Internal Medicine receiving lipid lowering therapy as secondary cardiovascular prevention are suitable for inclusion. Lipid lowering therapy is defined as the use of statins, fibrates, ezetimibe or nicotinic acid or a combination of these.
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51908.101.14 |
| OMON | NL-OMON26747 |