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Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00659321
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : January 11, 2012
Sponsor:
Collaborators:
Technische Universität Dresden
University of Regensburg
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dyslipidaemia Drug: nicotine acid Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : January 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

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Arm Intervention/treatment
Active Comparator: 1
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

Placebo Comparator: 2
16 weeks treatment with placebo
Drug: placebo
16 weeks treatment with placebo




Primary Outcome Measures :
  1. Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome [ Time Frame: after 16 weeks treatment ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659321


Locations
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Germany
GWT-TUD GmbH, Centre for Clinical Studies
Dresden, Germany, 01307
Sponsors and Collaborators
GWT-TUD GmbH
Technische Universität Dresden
University of Regensburg
Investigators
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Principal Investigator: Markolf Hanefeld, MD, PhD GWT-TUD GmbH

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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT00659321     History of Changes
Other Study ID Numbers: NIASPAN-DD-2005
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Metabolic Syndrome
Dyslipidemias
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action