Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

Phase 3

Completed

• Conditions: Metabolic Syndrome; Dyslipidaemia
• Interventions: Drug: nicotine acid; Drug: placebo

• Registration Number: NCT00659321
• Lead Sponsor: GWT-TUD GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-16
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	nicotine acid	16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
2	placebo	16 weeks treatment with placebo

Primary Outcome Measures

Name	Time	Method
Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome	after 16 weeks treatment

Trial Locations

Locations (1)

GWT-TUD GmbH, Centre for Clinical Studies; 🇩🇪 Dresden, Germany