Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia

Human Nutrition Research Centers (CRNH)

Status: Completed

Conditions: Lipid Profile; Lipoproteins Metabolism; Non Esterified Fatty Acid Kinetics; Insulin Sensitivity

Treatments: Drug: Extended-release nicotinic acid versus placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01216956

NIASPAN-C05-36

Details and patient eligibility

About

Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the drug has been used for so long, its precise mechanism of action remains elusive. The aim of this study was to characterise the metabolic changes induced by 8 week treatment with Niacin in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. In order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.

Full description

24 patients will be included in a double blind placebo controlled cross-over 8 week study comparing placebo to Niaspan (a long release formulation of niacin). In order to prevent any drop out linked to the flushing side effect of niacin, patient will take aspirin (300mg) prior to treatment throughout the study duration. The study will include at start and end of each arm, a full lipoproteins quantification as well as a measure of enzymes involved in lipid metabolism. On day 42 and 56 of each period, after an administration of either placebo or 500mg of immediate release niacin respectively, changes in plasma free fatty acid levels will be measured for 8hours in order to assess potential loss of activity of niacin over time upon chronic treatment with niaspan. Half of the patient will have an exploration of their glucose metabolism using hyperinsulinic clamp technique, whereas in the other half a metabolic turnover study using stable isotopes will focus on their lipoproteins, triglycerides and cholesterol handling. These explorations will be done at the end of each treatment period.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Waist circumference > 94cm
• Triglyceride concentration between 150mg/dL and 400mg/dL
• HDL-c < 60mg/dL
• Body mass index: 27 to 35 kg/m²

Exclusion criteria

• cancer
• diabetes mellitus
• hepatic, renal or digestive disorder
• hypertension
• chronic medical treatment interfering on lipids parameters

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Extended release nicotinic acid

Experimental group

Treatment:

Drug: Extended-release nicotinic acid versus placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Extended-release nicotinic acid versus placebo