Abnormal Lipids - Causes and Effects

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Jul 17, 2014

Keywords

ClinConnect Summary

This clinical trial, titled "Abnormal Lipids - Causes and Effects," is investigating the causes and effects of high triglyceride levels, particularly in patients who are already being treated with statin medications. The research focuses on understanding why some patients continue to have health risks, even when their cholesterol levels appear normal. Specifically, the study looks at different groups of patients, including those with type 2 diabetes, chronic kidney disease, and severe hypertriglyceridemia, to see how their lipid (fat) levels and markers of inflammation are connected.

If you or a family member have been treated with statins and have high triglyceride levels or are a patient with type 2 diabetes or advanced chronic kidney disease, you may be eligible to participate. Participants will undergo various assessments, including tests to measure lipid levels and nerve function. This trial aims to improve our understanding of lipid disorders and potentially uncover underdiagnosed conditions, which could lead to better treatment options in the future. It's important to note that certain individuals, such as those who are pregnant or have certain significant health issues, will not be able to participate.

Gender

ALL

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).