RECRUITINGOBSERVATIONAL

Abnormal Lipids - Causes and Effects

Hypertriglyceridaemia: Therapeutic Targets, Genetic Causes, and Associated Neuropathy

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - Nerve function arm •Patients known to have severe hypertriglyceridaemia (defined as triglyceride \>5.5 mmol/l) but not known to have diabetes and matched controls. - Genetic screening arm - Patients with a documented triglyceride level of more than 10 mmol/l at any time. - Criteria for screening for FH and LAL deficiency include non-obese patients (BMI \<30) with low HDL-C (\<1.0 mmol/l male and \<1.3 mmol female), high triglycerides \>1.7 mmol/l, high total cholesterol \>6.2 or LDL cholesterol \>4.7 mmol/l; patients with raised liver alanine aminotransferase (ALT) (1.5 x above ULN) but no metabolic or viral disease or alcohol excess and patients diagnosed with NAFLD with or without hyperlipidaemia. Who Should NOT Join This Trial: - 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). - Untreated hypothyroid and hyperthyroidism (if treated and TFT normal could be recruited). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. * Nerve function arm •Patients known to have severe hypertriglyceridaemia (defined as triglyceride \>5.5 mmol/l) but not known to have diabetes and matched controls. * Genetic screening arm * Patients with a documented triglyceride level of more than 10 mmol/l at any time. * Criteria for screening for FH and LAL deficiency include non-obese patients (BMI \<30) with low HDL-C (\<1.0 mmol/l male and \<1.3 mmol female), high triglycerides \>1.7 mmol/l, high total cholesterol \>6.2 or LDL cholesterol \>4.7 mmol/l; patients with raised liver alanine aminotransferase (ALT) (1.5 x above ULN) but no metabolic or viral disease or alcohol excess and patients diagnosed with NAFLD with or without hyperlipidaemia. Exclusion Criteria: * 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). * Untreated hypothyroid and hyperthyroidism (if treated and TFT normal could be recruited).

Locations (1)

Cardiovascular Trials Unit

Manchester, United Kingdom