Investigating the Causes and Effects of Abnormal Lipid Levels

Hypertriglyceridaemia: Therapeutic Targets, Genetic Causes, and Associated Neuropathy

This study is trying to understand how high triglyceride levels affect heart health in people with severe hypertriglyceridaemia, type 2 diabetes, or chronic kidney disease, to find better ways to lower their risk of heart problems.

Quick facts

• Study type: Observational
• Enrollment: 1396 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Manchester University NHS Foundation Trust (other gov)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Manchester)
• Trial ID: NCT02195050 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include statin-treated patients with hypertriglyceridaemia, type 2 diabetes, or chronic kidney disease.

Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with hypertriglyceridaemia, potentially reducing their cardiovascular risk.

How similar studies have performed: Other studies have shown success in exploring lipid profiles and cardiovascular risk, but this specific approach focusing on apoB and nerve damage is relatively novel.

Eligibility criteria

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 this trial is running

Manchester

• 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

Conditions: Hypertriglyceridaemia