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

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

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.

Study Overview

• Status: Terminated
• Conditions: Metabolic Syndrome; Hyperlipoproteinemia
• Intervention / Treatment: Drug: Niacin/ Laropiprant

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81377
    • Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Niacin/ Laropiprant	Drug: Niacin/ Laropiprant; 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily; Other Names: Tredaptive; EU/1/08/459/001

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDL Cholesterol	Percent change of HDL-cholesterol at 12 weeks compared to baseline.	baseline and 12 weeks after treatment
Fasting Triglycerides	Percent change of fasting triglycerides at 12 weeks compared to baseline	baseline and 12 weeks after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-cholesterol	Percent change of LDL-cholesterol at 12 weeks compared to baseline	baseline and 12 weeks after treatment

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Klaus Parhofer, MD, Prof., Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 12, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 15, 2010

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Metabolic Syndrome; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Niacin
• Other Study ID Numbers: KP-Niacin-2010; 2010-019954-42 (EudraCT Number)