[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100224113":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":22,"locations":28,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":10,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Manchester University NHS Foundation Trust","OTHER_GOV",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Therapeutic target arm",null,"Statin treated patients with and without raised triglycerides who do not have diabetes or dysglycemia. Statin treated patients with type 2 diabetes.Statin treated patients with CKD stages 4 and 5 (eGFR ≤30mL\u002Fmin).",{"label":13,"type":10,"description":14,"interventionNames":10},"Nerve function arm","Patients with severe hypertriglyceridaemia (fasting TG \\> 5.5mmol\u002Fl.) are recruited for nerve function assessment and corneal confocal microscopy.",{"label":16,"type":10,"description":17,"interventionNames":10},"Genetic screening arm","For LAL deficiency screening, patients will be recruited over a 5 year period with a documented triglyceride level of more than 10 mmol\u002Fl at any time, low HDLC, raised ALT, combined hyperlipidaemia, or non-alcoholic fatty liver disease. Patients recruited from Manchester will be offered additional genetic testing for familial hypercholesterolaemia.",[19],{"name":20,"affiliation":5,"role":21},"Handrean Soran, MD FRCP","PRINCIPAL_INVESTIGATOR",[23],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"See Kwok, MD FRCGP","CONTACT","01612768863","sk7@doctors.org.uk",[29],{"facility":30,"status":31,"city":32,"state":10,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Cardiovascular Trials Unit","RECRUITING","Manchester","M13 9WL","United Kingdom","UK",{"type":37,"coordinates":38},"Point",[39,40],-2.23743,53.48095,{"lat":40,"lon":39},[43,44],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},{"name":24,"role":45,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100224113","abnormal-lipids---causes-and-effects-100224113",false,"NCT02195050","Abnormal Lipids - Causes and Effects","Hypertriglyceridaemia: Therapeutic Targets, Genetic Causes, and Associated Neuropathy","Inclusion Criteria:\n\n* Therapeutic target arm\n\n  * Statin treated patients with and without hypertriglyceridemia.\n  * Statin treated patients with type 2 diabetes.\n  * Statin treated patients with CKD stages 4 and 5.\n* Nerve function arm\n\n  •Patients known to have severe hypertriglyceridaemia (defined as triglyceride \\>5.5 mmol\u002Fl) but not known to have diabetes and matched controls.\n* Genetic screening arm\n\n  * Patients with a documented triglyceride level of more than 10 mmol\u002Fl at any time.\n  * Criteria for screening for FH and LAL deficiency include non-obese patients (BMI \\\u003C30) with low HDL-C (\\\u003C1.0 mmol\u002Fl male and \\\u003C1.3 mmol female), high triglycerides \\>1.7 mmol\u002Fl, high total cholesterol \\>6.2 or LDL cholesterol \\>4.7 mmol\u002Fl; 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.\n\nExclusion Criteria:\n\n* Pregnant and\u002For breast-feeding women.\n* Significant liver impairment.\n* Patients known to have active malignant disease.\n* Patients treated with medications that could affect lipoprotein metabolism significantly (like atypical antipsychotics, chemotherapy).\n* Untreated hypothyroid and hyperthyroidism (if treated and TFT normal could be recruited).","ALL","18 Years",{"count":58,"type":59},1396,"ESTIMATED","OBSERVATIONAL","1. At target LDL-C levels, apoB100 concentrations will be higher than recommended levels in the following populations:\n\n   1. Tertiary centre lipid clinic patients with raised TG treated with statins.\n   2. Patients with type 2 diabetes treated with statins.\n   3. Patients with Chronic Kidney disease (CKD) stages 4 and 5 treated with statins.\n2. Despite achieving LDL-C and non-HDL-C targets, a significant number of statin-treated patients have residual cardiovascular risk related to raised hsCRP. The relationship between hsCRP and Lp-PLA2 (markers of inflammation) and LDL particle number measured by apoB100 is stronger than that of measured and calculated LDL and non-HDL. In statin treated patients there will be higher levels of hs-CRP and Lp-PLA2 in patients achieving LDL targets but not apo B targets.\n3. We hypothesise that non-diabetic patients with severe hypertriglyceridaemia (fasting serum triglyceride \\>5.5 mmol\u002Fl) have evidence of greater nerve damage compared with matched controls.\n4. LAL deficiency is underdiagnosed in patients with severe hypertriglyceridaemia, low HDL-C, hyperlipidaemias, non alcoholic fatty liver disease and idiopathic high liver enzymes.",[63],"Hypertriglyceridaemia","2023-05-30",{"date":66,"type":67},"2023-05-31","ACTUAL",{"date":69,"type":67},"2014-01-23",{"date":71,"type":59},"2030-12",{"name":5,"class":6},1]