Placebokontrollierte Untersuchung zur Wirkung von Nikotinsäure auf die Dyslipidämie bei Metabolischem Syndrom und das Arterioskleroserisiko - Niaspa

• Conditions: Dyslipidemia (Hypertriglyzeridemia and/or low HDL-cholersterol) with metabolic syndrome

• Registration Number: EUCTR2005-002597-30-DE
• Lead Sponsor: Gesellschaft für Wissens- und Technologietransfer der TU Dresden mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol <40 mg/dl in men or < 50 mg/dl in women) and with further components of the metabolic syndrome:
Hypertension: blood pressure >= 130/85 mmHg or/and
Hyperglycemia: fasting plasma glucose >= 100 mg/dl or/and
2 hour plasma glucose after 75g glucose load (OGTT) >= 140 mg/dl or/and
Obesity: waist circumferences > 102 cm in men or >88 cm in women

age between 30 and 75 years

informed consent

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

-Contraindication and incompatibility of nicotine acid
-Patients with ulcus ventriculi or ulcus duodeni
-Intake of lipid lowering drugs < 6 weeks before randomization
-therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit)
-no acceptable therapy of diabetes with levels of HbA1C>=8.0%
-cardiovascular events in the last 6 months
-chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
-ALAT elevation 2.5 times more than the normal limit
-pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Placebo controlled evaluation of effectiveness of niaspan in treatment of postprandial dyslipidemia in patients with metabolic syndrome;Secondary Objective: Influence of:<br>-markers of subclinical inflammation<br>-changes of levels of plasma glucose and free fatty acids before and after a standard meal<br>-albuminuria<br>-parameters of atherosclerotic risk factors<br>;Primary end point(s): no defined