Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Placebokontrollierte Untersuchung Zur Wirkung Von Nikotinsäure Auf Die Dyslipidämie Bei Metabolischem Syndrom Und Das Arterioskleroserisiko (Placebo Controlled Investigation of Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome and the Risk of Atherosclerosis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659321
• Other study ID #: NIASPAN-DD-2005
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2008
• Last updated: January 10, 2012
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2012
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidemias
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• 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
• placebo
16 weeks treatment with placebo

Locations

Country	Name	City	State
Germany	GWT-TUD GmbH, Centre for Clinical Studies	Dresden

Sponsors (3)

Lead Sponsor	Collaborator
GWT-TUD GmbH	Technische Universität Dresden, University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome		after 16 weeks treatment	No