Status:
RECRUITING
Abnormal Lipids - Causes and Effects
Lead Sponsor:
Manchester University NHS Foundation Trust
Conditions:
Hypertriglyceridaemia
Eligibility:
All Genders
18+ years
Brief Summary
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....
Detailed Description
Fats are present in the body in the form of lipid particles containing cholesterol and triglycerides. Lipid particles can deposit in blood vessels, forming atheromas, blocking blood vessels and leadin...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 23 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
1396 Patients enrolled
Trial Details
Trial ID
NCT02195050
Start Date
January 23 2014
End Date
December 1 2030
Last Update
May 31 2023
Active Locations (1)
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1
Cardiovascular Trials Unit
Manchester, United Kingdom, M13 9WL