Trial document




drksid header

  DRKS00007125

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A high level of cholesterol is an important risk factor for cardiovascular diseases. Patients with familial hypercholesterolemia (FH) have a disordered LDL-metabolism, and a higher risk to suffer a cardiovascular disease. Further it is known that the composition of lipoproteins in FH patients is different compared to the corresponding composition in healthy probands.
In this study certain parameters of the fat metabolism are measured. Out of this data we try to describe the LDL metabolism in healthy humans as well as in FH-Patients with an mathematical model. The lipidmetabolism-parameters are measured before and after administration of the statin 'Atorvastatin' in the FH-patients.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In this case-control study without therapeutical intervention 2 collectives are considered: A group of male patients with (possible) familial hypercholesterolemia without lipidlowering medication and a group of male age-matched participants without a disorder of lipometabolism and without relevant internistic deseases.
Based on lipoprotein composition and certain enzyme activities, which are related to lipoproteins, we try to make an in silico -estimation of the lipoprotein metabolism. We focus on the function of LDL-lipoproteins in intracellular cholesterol transport. Further the influence of the drug 'Atorvastatin' on the lipid-metabolism in the FH-patients is studied. Atorvastatin is an often used drug for people with FH.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007125
  •   2015/05/19
  •   [---]*
  •   yes
  •   Approved
  •   30/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1163-5436 
  •   2014-005473-36 
  •   4040407 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E78.0 -  Pure hypercholesterolaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Male patients with (possible) familial hypercholesterolemia between 18 and 75 years.
    First timepoint: The patients are not under the influence of medication affection the fat metabolism (e.g. statins).
    Second timepoint: The patients took Atorvastatin for 3-4 month.
  •   Healthy, male probands without a disorder of the fat metabolism. These probands are age-matched to the FH-patients.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/10/09
  •   30
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin
    • Mr.  Prof. Dr.  Karl  Winkler 
    • Hugstetter Str. 55
    • 79106  Freiburg i. Br.
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin
    • Mr.  Prof. Dr.  Karl  Winkler 
    • Hugstetter Str. 55
    • 79106  Freiburg i. Br.
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin
    • Ms.  Dr. med  Brigitte  König 
    • Hugstetter Str. 55
    • 79106  Freiburg i. Br.
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin
    • Mr.  Prof. Dr.  Karl  Winkler 
    • Hugstetter Str. 55
    • 79106  Freiburg i. Br.
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2020/02/05
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.