Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT02195050
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02195050
Study Brief:
Protocol Section:
NCT02195050