Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia

Phase 4

Terminated

• Conditions: Hyperlipoproteinemia; Metabolic Syndrome
• Interventions: Drug: Niacin/ Laropiprant

• Registration Number: NCT01239992
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-07
• Results First Submitted: 2013-12-02
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-12
• Last Update Submitted: 2014-03-12
• Results First Posted: 2014-04-10
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Male subjects or postmenopausal female subjects aged between 19-70 years
• High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d
• HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl
• Lipoprotein (a) < 30 mg/dl
• Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus.
• Without niacin therapy for at least 6 months
• Dosage of any concomitant medication has been stable for at least 3 weeks
• If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml)

Exclusion Criteria

• Subjects with additional causes for hyperlipoproteinemia
• Diabetes mellitus or antidiabetic medication
• Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
• History of psychiatric disorder or cognitive impairment that would interfere with participation in the study
• History of alcoholism
• Contraindication against niacin and/or laropiprant
• Subject has participated in an investigational study within 30 days prior to study initiation
• Fasting triglycerides >400 mg/dl
• Life-threatening disease (e.g. cancer)
• Renal insufficiency (GFR ≤ 30 ml/min )
• Major hepatic impairment
• Known allergic reaction/intolerance against niacin and/or laropiprant
• Active peptic ulcer disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Niacin/ Laropiprant	Niacin/ Laropiprant	-

Primary Outcome Measures

Name	Time	Method
Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test	baseline and 12 weeks after treatment	Percent change of incremental AUC at 12 weeks compared to baseline.

Secondary Outcome Measures

Name	Time	Method
HDL Cholesterol	baseline and 12 weeks after treatment	Percent change of HDL-cholesterol at 12 weeks compared to baseline.
Fasting Triglycerides	baseline and 12 weeks after treatment	Percent change of fasting triglycerides at 12 weeks compared to baseline

Trial Locations

Locations (1)

Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern; 🇩🇪 Munich, Germany