Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

GWT-TUD

Status and phase: Completed; Phase 3

Conditions: Dyslipidaemia; Metabolic Syndrome

Treatments: Drug: nicotine acid; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00659321

NIASPAN-DD-2005

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: nicotine acid

2

Placebo Comparator group

Description:

16 weeks treatment with placebo

Treatment:

Drug: placebo