Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome - Full Text View

Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	GWT-TUD GmbH University Clinic of Technical University Dresden; Institute of Clinical Chemistry University Regensburg; University Clinic, Institute of Clinical Chemistry
Information provided by:	GWT-TUD GmbH
ClinicalTrials.gov Identifier:	NCT00659321

Purpose

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.

Condition	Intervention	Phase
Metabolic Syndrome Dyslipidaemia	Drug: nicotine acid Drug: placebo	Phase III

ChemIDplus related topics:

Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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)

Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:

Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome [ Time Frame: after 16 weeks treatment ] [ Designated as safety issue: No ]

Enrollment:	68
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication	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
2: Placebo Comparator 16 weeks treatment with placebo	Drug: placebo 16 weeks treatment with placebo

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659321

Locations


Germany
	GWT-TUD GmbH, Centre for Clinical Studies
	Dresden, Germany, 01307

Sponsors and Collaborators

GWT-TUD GmbH

University Clinic of Technical University Dresden; Institute of Clinical Chemistry

University Regensburg; University Clinic, Institute of Clinical Chemistry

Investigators


Principal Investigator:	Markolf Hanefeld, MD, PhD	GWT-TUD GmbH

More Information

Responsible Party:	GWT-TUD GmbH ( Hanefeld, Markolf MD, PhD )
Study ID Numbers:	NIASPAN-DD-2005
First Received:	April 10, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00659321
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Nicotine polacrilex

Atherosclerosis

Metabolic Diseases

Nicotine

Metabolic disorder

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents

Disease

Cholinergic Agonists

Molecular Mechanisms of Pharmacological Action

Nicotinic Agonists

Physiological Effects of Drugs

Central Nervous System Stimulants

Cholinergic Agents

Pharmacologic Actions

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Syndrome

Ganglionic Stimulants

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2008