Actively Recruiting

Age: 18Years +
All Genders
NCT02195050

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cardiovascular Trials Unit

Manchester, United Kingdom, M13 9WL

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here