Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

Sponsor

GWT-TUD GmbH (Other)

Overall Status

Completed

CT.gov ID

NCT00659321

Collaborator

Technische Universität Dresden (Other), University of Regensburg (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome [after 16 weeks treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GWT-TUD GmbH, Centre for Clinical Studies	Dresden		Germany	01307

Sponsors and Collaborators

GWT-TUD GmbH
Technische Universität Dresden
University of Regensburg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GWT-TUD GmbH

ClinicalTrials.gov Identifier:

NCT00659321

Other Study ID Numbers:

NIASPAN-DD-2005

First Posted:

Apr 16, 2008

Last Update Posted:

Jan 11, 2012

Last Verified:

Jan 1, 2012

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2012