About this trial
1. At target LDL-C levels, apoB100 concentrations will be higher than recommended levels in the following populations:
1. Tertiary centre lipid clinic patients with raised TG treated with statins. 2. Patients with type 2 diabetes treated with statins. 3. Patients with Chronic Kidney disease (CKD) stages 4 and 5 treated with statins. 2. Despite achieving LDL-C and non-HDL-C targets, a significant number of statin-treated patients have residual cardiovascular risk related to raised hsCRP. The relationship between hsCRP and Lp-PLA2 (markers of inflammation) and LDL particle number measured by apoB100 is stronger than that of measured and calculated LDL and non-HDL. In statin treated patients there will be higher levels of hs-CRP and Lp-PLA2 in patients achieving LDL targets but not apo B targets. 3. We hypothesise that non-diabetic patients with severe hypertriglyceridaemia (fasting serum triglyceride \>5.5 mmol/l) have evidence of greater nerve damage compared with matched controls. 4. LAL deficiency is underdiagnosed in patients with severe hypertriglyceridaemia, low HDL-C, hyperlipidaemias, non alcoholic fatty liver disease and idiopathic high liver enzymes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Therapeutic target arm
Statin treated patients with and without hypertriglyceridemia.
Statin treated patients with type 2 diabetes.
Statin treated patients with CKD stages 4 and 5.
Disqualifiers
Pregnant and/or breast-feeding women.
Significant liver impairment.
Patients known to have active malignant disease.
Patients treated with medications that could affect lipoprotein metabolism significantly (like atypical antipsychotics, chemotherapy).
Trial population
Patients are recruited from secondary and tertiary care hospital clinics.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Measurement of ApoB in specified patient populations to gauge cardiovascular risk.
Residual risk due to the presence of sd-LDL and reflected in a discrepancy between apoB and cholesterol indices is correlated with hs-CRP.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.