Actively Recruiting
Abnormal Lipids - Causes and Effects
Led by Manchester University NHS Foundation Trust · Updated on 2023-05-31
1396
Participants Needed
1
Research Sites
879 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Abnormal Lipids - Causes and Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Statin treated patients with and without hypertriglyceridaemia
- Statin treated patients with type 2 diabetes
- Statin treated patients with chronic kidney disease stages 4 and 5
- Patients with severe hypertriglyceridaemia (triglycerides >5.5 mmol/l) without diabetes and matched controls
- Patients with documented triglyceride levels over 10 mmol/l
- Non-obese patients (BMI <30) with low HDL-C (male <1.0 mmol/l, female <1.3 mmol/l), high triglycerides >1.7 mmol/l, high total cholesterol >6.2 mmol/l or LDL cholesterol >4.7 mmol/l
- Patients with raised liver alanine aminotransferase (ALT) (1.5 times above upper limit of normal) without metabolic or viral disease or alcohol excess
- Patients diagnosed with non-alcoholic fatty liver disease (NAFLD) with or without hyperlipidaemia
You will not qualify if you...
- Pregnant or breastfeeding women
- Significant liver impairment
- Patients with active malignant disease
- Patients treated with medications significantly affecting lipoprotein metabolism (e.g., atypical antipsychotics, chemotherapy)
- Untreated hypothyroidism or hyperthyroidism (treated and thyroid function tests normal patients may be included)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cardiovascular Trials Unit
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
S
See Kwok, MD FRCGP
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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