Investigating the Causes and Effects of Abnormal Lipid Levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with hypertriglyceridaemia to explore therapeutic targets, genetic causes, and associated nerve damage. It aims to assess the relationship between lipid levels, specifically apolipoprotein B (apoB), and cardiovascular risk in patients treated with statins. The study will recruit individuals with severe hypertriglyceridaemia and those with type 2 diabetes or chronic kidney disease to evaluate their lipid profiles and inflammatory markers. By understanding these relationships, the study seeks to identify better treatment targets for reducing cardiovascular risk.

Why it matters

Who can join: the full rules

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).

Where it's running

• Cardiovascular Trials Unit
  Manchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Handrean Soran, MD FRCP — Manchester University NHS Foundation Trust
• Study coordinator: See Kwok, MD FRCGP
• Email: sk7@doctors.org.uk
• Phone: 01612768863

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.