Abnormal Lipids - Causes and Effects

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorManchester University NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

1,396 Participants
are grouped into 3 trial groups
Group A: Therapeutic target arm
Group B: Nerve function arm
Group C: Genetic screening arm

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day.

Secondary outcomes

Other outcomes

Sponsors and contacts

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