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

NCT ID: NCT01216956

Last Updated: 2010-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Insulin Sensitivity Lipoproteins Metabolism Non Esterified Fatty Acid Kinetics Lipid Profile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Study Groups

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Extended release nicotinic acid

Group Type EXPERIMENTAL

Extended-release nicotinic acid versus placebo

Intervention Type DRUG

Voluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite.

Placebo

Group Type PLACEBO_COMPARATOR

Extended-release nicotinic acid versus placebo

Intervention Type DRUG

Voluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite.

Interventions

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Extended-release nicotinic acid versus placebo

Voluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Centre de Recherche en Nutrition Humaine Rhone-Alpe

OTHER

Sponsor Role lead

Responsible Party

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Institut National de la Santé Et de la Recherche Médicale, France

Principal Investigators

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Michel Krempf, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recheche Médiacle

Locations

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Centre de Recherche en Nutrition Humaine

Nantes, , France

Site Status

Countries

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France

References

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Blanchard V, Ramin-Mangata S, Billon-Crossouard S, Aguesse A, Durand M, Chemello K, Nativel B, Flet L, Chetiveaux M, Jacobi D, Bard JM, Ouguerram K, Lambert G, Krempf M, Croyal M. Kinetics of plasma apolipoprotein E isoforms by LC-MS/MS: a pilot study. J Lipid Res. 2018 May;59(5):892-900. doi: 10.1194/jlr.P083576. Epub 2018 Mar 14.

Reference Type DERIVED
PMID: 29540575 (View on PubMed)

Ferchaud-Roucher V, Croyal M, Moyon T, Zair Y, Krempf M, Ouguerram K. Plasma Lipidome Analysis by Liquid Chromatography-High Resolution Mass Spectrometry and Ion Mobility of Hypertriglyceridemic Patients on Extended-Release Nicotinic Acid: a Pilot Study. Cardiovasc Drugs Ther. 2017 Jun;31(3):269-279. doi: 10.1007/s10557-017-6737-y.

Reference Type DERIVED
PMID: 28752209 (View on PubMed)

Other Identifiers

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NIASPAN-C05-36

Identifier Type: -

Identifier Source: org_study_id