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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01239992
• Other study ID #: KP-Niacin-2010
• Secondary ID: 2010-019954-42
• Status: Terminated
• Phase: Phase 4
• First received: November 12, 2010
• Last updated: March 12, 2014
• Start date: June 2011
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipoproteinemia
• Hyperlipoproteinemias
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Niacin/ Laropiprant
1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily

Locations

Country	Name	City	State
Germany	Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LDL-cholesterol	Percent change of LDL-cholesterol at 12 weeks compared to baseline	baseline and 12 weeks after treatment	No
Primary	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	No
Secondary	HDL Cholesterol	Percent change of HDL-cholesterol at 12 weeks compared to baseline.	baseline and 12 weeks after treatment	No
Secondary	Fasting Triglycerides	Percent change of fasting triglycerides at 12 weeks compared to baseline	baseline and 12 weeks after treatment	No