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Modelling the effect of fibrates on lipoproteins in patients with dyslipidemia

Recruiting
Conditions
HYPERTRIGLYCERIDMIE
E78
Disorders of lipoprotein metabolism and other lipidaemias
Registration Number
DRKS00017404
Lead Sponsor
niversitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

• Age = 18
• written consent
• Serum TG > 600 mg/dl

Exclusion Criteria

1. serious liver dysfunction (Child-Pugh C)
2. serious kidney dysfunction, with GFR < 30 ml/min/1,73 m²
3. TSH not normal
4. not-controlled arterial hypertension: systolic RR > 160 mmHg or diastolic bp > 105 mmHg.
5. alcoholabusus, or abusus of other drugs (but nicotine)
6. Blood-donation within the last 6 weeks prior to the first blood withdrawal
7. Patients with serious acute diseases
8. HbA1c > 8.0%
9. Other serious internistic diseases, associated to the lipid-metabolism
10. hypersensivity to fibrats
11. pregnancy, planned pregnancy or lactation

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Estimation of the lipidfluxes (per Cholesterol ester-Transferprotein (CETP), Lecithin-Cholesterol-Acyltransferase (LCAT) and hepatic lipasis (HL)) in low density lipoproteins (LDL) and high density lipoproteins (HDL). This is done with a mathematical model, based on measurements of triglyzerides, unesterified cholesterol, and cholesterol estern in very low density lipoproteins (VLDL) , intermediate density lipoproteins (IDL), LDL and HDL, as well as Apolipoprotein B-100 (ApoB) in VLDL, IDL, LDL and Apolipoprotein A1 (ApoA1) in HDL.
Secondary Outcome Measures
NameTimeMethod
- Concentration of phospholipids in VLDL, IDL, LDL and HDL and concentration of triglyzerides, cholesterpl, Cholesterpl ester, phospholipids in the subfractions of LDL und HDL <br>- ApoB in VLDL, IDL, LDL-1 to LDL-6 and ApoAI in HDL subfractionen 2a, 2b und HDL-3 <br>- HDL-functionality<br>- concentration and distribution of other apolipoproteins in the lipoprotein-subfractions<br>- Activities of the enzyms: phospholipid-transfer-protein (PLTP), lipoprotein-associated phospholipase A2 (Lp-PLA2) <br>
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