Modeling of lipoprotein in patients with familial hypercholesterolemia compared to healthy subjects

Not Applicable

• Conditions: E78.0; Pure hypercholesterolaemia

• Registration Number: DRKS00007125
• Lead Sponsor: niversitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-19
• Study Completion: 2020-02-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

inclusion criteria for FH:
• written consent
• positive Simon Broome criteria (possible and definitely)
• no lipid-lowering therapy in the 6 weeks before inclusion

inclusion criteria control subjects:
• written consent
• Patients without disorder of LDL metabolism, proven by< 200 mg/dl cholesteryl, < 150 mg/dl triglycerides and <160 mg/dl LDL-cholesteryl in fasting plasma
• no relevant internistic deseases and no lipidlowering therapy in the 6 weeks before inclusion

Exclusion Criteria

1.Active Liver-disease or impairment of liver function with GOT and/or GPT > 2 x value of the Upper Limit of Normal= (ULN)
2.mid-level or severe renal insufficiency
3.TSH not im reference range
4.uncontrolled aterial hypertension: Diastolic RR = 105 mmHg and/or systolic RR = 160 mmHg
5.lipid-lowering therapy within the last 6 weeks before the screening
6.Smoker, alcohol abuse or other drug abuse
7.blood donation within the last 6 weeks before the screening
8.Patients with a adverse acute disease
9. HbA1c > 6.5%
10.Other important striking internistic diseases, which may alter the lipidmetabolism

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ApoB, TG, FC and CE distribution in the LDL and their subfractions

Secondary Outcome Measures

Name	Time	Method
activity of the following enzyms: LCAT, CETP, PLTP, LP-PLA2. HDL functionality-test. Concentration of the lipids: TG, CE, free cholesterol (FC) and phospholipids (PL) in all lipoprotein-subfractions concentration of the apolipoproteins: ApoA1, Apolipoprotein-A2, Apolipoprotein B-100, Apolipoprotein-E, Apolipoprotein-CII, Apolipoprotein-CIII and Lipoprotein Lp(a) in all lipoprotein subfractions