Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00659321

Enrollment

Registered

2008-04-16

Start date

2007-01-31

Completion date

2008-12-31

Last updated

2012-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemia, Metabolic Syndrome

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.

Interventions

DRUGnicotine acid

16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication

DRUGplacebo

16 weeks treatment with placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026