Effect of Niacin/ Laropiprant on postprandial lipoprotein and glucose metabolism in patients with severe dyslipoproteinemia

Conditions: Dyslipoproteinemia
MedDRA version: 12.1Level: LLTClassification code 10063903Term: Dyslipoproteinemia
MedDRA version: 12.1Level: LLTClassification code 10052066Term: Metabolic syndrome

Registration Number: EUCTR2010-019954-42-DE

Lead Sponsor: Med. Klinik II, Klinikum der Universität München Grosshadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Men and postmenopausal women (19-70 years)
High risk patients (PROCAM risk > 20%) on a stable statin-therapy with simvastatin, but at least 20 mg/d
HDL-cholesterol < 50 mg/dl, triglycerides 150-400 mg/dl, LDL-cholesterol 70-150 mg/dl
Without niacin therapy for at least 6 months
Lipoprotein (a) < 30 mg/dl
Dosage of concomitant medication has been stable for at least 3 weeks
If female, postmenopausal for the past 12 months
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with additional causes for hyperlipoproteinemia
Diabetes mellitus or antidiabetic medication
History of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
History of alcoholism
History of psychiatric disorder
Contraindication against niacin/ laropiprant
Fasting triglycerides > 400 mg/dl
Major hepatic impariment
Active peptic ulcer disease
Renal insufficiency
Life threatening disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to evaluate the postprandial lipoprotein metabolism particularly the change of the incremental area under the plasma triglyceride curve after a standardized fat tolerance test.;Secondary Objective: Secondary objectives of the trial are to evaluate fasting lipids, postprandial postprandial glucose metabolism, monocyte function and biomarkers of endothelial dysfunction and inflammation.;Primary end point(s): Incremental area under the plasma triglyceride curve following a standardized oral fat tolerance test.

Secondary Outcome Measures