Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation and the risk of atherosclerosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Collaborators: Technische Universität Dresden; University of Regensburg
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol <40 mg/dl in men or < 50 mg/dl in women)

• 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

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