Hypertriglyceridaemia: Therapeutic Targets, Genetic Causes, and Associated Neuropathy

Trial Information
Status: Recruiting
Location: See location...
Study Type: Observational
Summary

At target LDL-C levels, apoB100 concentrations will be higher than recommended levels in the following populations: Tertiary centre lipid clinic patients with raised TG treated with statins. Patients with type 2 diabetes treated with statins. Patients with Chronic Kidney disease (CKD) stages 4 and 5 treated with statins. 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. 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. LAL deficiency is underdiagnosed in patients with severe hypertriglyceridaemia, low HDL-C, hyperlipidaemias, non alcoholic fatty liver disease and idiopathic high liver enzymes.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• 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.

Where is this trial taking place?
Other Locations
United Kingdom
Cardiovascular Trials Unit
Recruiting
Manchester
Who do I contact about this trial?
Primary
See Kwok, MD FRCGP
sk7@doctors.org.uk
01612768863
When is this trial taking place?
Start Date: January 23, 2014
Estimated Completion Date: December 2030
How many participants will be in this trial?
Target number of participants: 1396
What treatment is being studied in this trial?
Therapeutic target arm
Statin treated patients with and without raised triglycerides who do not have diabetes or dysglycemia. Statin treated patients with type 2 diabetes.Statin treated patients with CKD stages 4 and 5 (eGFR ≤30mL/min).
Nerve function arm
Patients with severe hypertriglyceridaemia (fasting TG > 5.5mmol/l.) are recruited for nerve function assessment and corneal confocal microscopy.
Genetic screening arm
For LAL deficiency screening, patients will be recruited over a 5 year period with a documented triglyceride level of more than 10 mmol/l at any time, low HDLC, raised ALT, combined hyperlipidaemia, or non-alcoholic fatty liver disease. Patients recruited from Manchester will be offered additional genetic testing for familial hypercholesterolaemia.
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov