mathematical modelling of the fat metabolism in healthy subjects and patients suffering the desease familial hypercholesterolemia

Phase 1

• Conditions: familial hypercholesterolemia; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-005473-36-DE
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-26
• Study Completion: 2020-02-05
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

inclusion criteria for FH:
• Age 18-75 years
• written consent
• positive Simon Broome criteria (possible and definitely)
• no lipid-lowering therapy in the 6 weeks before inclusion
inclusion criteria control subjects:
• Age 18-75 years
• 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
• no lipid-lowering medication 6 weeks before the first study-associated blood withdrawl and until the second visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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. alcohol abuse, smoking 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is to develope a mathematical model describing the lipoproteins of low density (LDL) in healthy probands and patients with familial hypercholesterinemia based on clinical data;Secondary Objective: Secondary objectives are to characterize the influence of statin on LDL metabolism and to compare healthy probands and patients with familial hypercholesterinemia.;Primary end point(s): Apolipoprotein B (ApoB), triglyceride (TG), free cholesteryl (FC) and cholesteryl ester (CE) distribution in the LDL and their subfractions;Timepoint(s) of evaluation of this end point: each visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): activity of the following enzyms: Lecithin—cholesterol acyltransferase (LCAT), Cholesterylester transfer protein (CETP), Phospholipid transfer protein (PLTP), Lipoprotein-associated phospholipase A2 (LP-PLA2)<br>concentration of the lipids: TG, CE, FC and phospholipids (PL) in all lipoprotein-subfractions concentration of the apolipoproteins:<br>Apolipoprotein-A1, Apolipoprotein-A2, Apolipoprotein B-100, Apolipoprotein-E, Apolipoprotein-CII, Apolipoprotein-CIII<br>and Lipoprotein Lp(a) in all lipoprotein subfractions, HDL functionality;Timepoint(s) of evaluation of this end point: each visit