Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 7, 2010
CompletedOctober 7, 2010
October 1, 2010
2.8 years
October 5, 2010
October 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of non-esterified fatty acid and triglycerides concentrations over time
Twelve hours after ingestion of chronic treatment, measures of non esterified fatty acid and triglycerides concentrations were carried out during 480 minutes to assess acute and chronic treatment effect on lipolysis and on triglyceride concentration. To appreciate both acute and chronic effects, subjects received medicinal supplements in addition to their chronic treatment: * On day 42, 500 mg of placebo to assess chronic nicotinic acid effect versus placebo effect * On day 56, 500 mg of immediate-release nicotinic acid (INA) to assess acute versus chronic nicotinic acid effect.
After 42 and 56 days of placebo or nicotinic acid treatment
Secondary Outcomes (3)
Insulin sensitivity after treatment
After 53 days of placebo or nicotinic acid treatment
Lipoproteins metabolism
After 53 days of placebo or nicotinic acid treatment
Lipid profile
Before and after placebo or nicotinic acid treatment
Study Arms (2)
Extended release nicotinic acid
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Waist circumference \> 94cm
- Triglyceride concentration between 150mg/dL and 400mg/dL
- HDL-c \< 60mg/dL
- Body mass index: 27 to 35 kg/m²
You may not qualify if:
- cancer
- diabetes mellitus
- hepatic, renal or digestive disorder
- hypertension
- chronic medical treatment interfering on lipids parameters
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Recherche en Nutrition Humaine
Nantes, France
Related Publications (2)
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.
PMID: 29540575DERIVEDFerchaud-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.
PMID: 28752209DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Krempf, PhD, MD
Institut National de la Santé Et de la Recheche Médiacle
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 7, 2010
Study Start
September 1, 2006
Primary Completion
June 1, 2009
Study Completion
March 1, 2010
Last Updated
October 7, 2010
Record last verified: 2010-10