Clinical trial NCT01239992: Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
Official title: Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hyperlipoproteinemia
Metabolic Syndrome
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test
timeFrame: baseline and 12 weeks after treatment
Secondary outcomes:
measure: HDL Cholesterol
timeFrame: baseline and 12 weeks after treatment
measure: Fasting Triglycerides
timeFrame: baseline and 12 weeks after treatment
Other outcomes:
measure: LDL-cholesterol
timeFrame: baseline and 12 weeks after treatment
Locations:
city: Munich
country: Germany
facility: Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
Study officials:
affiliation: Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
name: Klaus Parhofer, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: