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

This study has been completed.
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
GlaxoSmithKline
Information provided by:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
ClinicalTrials.gov Identifier:
NCT01216956
First received: October 5, 2010
Last updated: October 6, 2010
Last verified: October 2010

October 5, 2010
October 6, 2010
September 2006
June 2009   (final data collection date for primary outcome measure)
Evolution of non-esterified fatty acid and triglycerides concentrations over time [ Time Frame: After 42 and 56 days of placebo or nicotinic acid treatment ] [ Designated as safety issue: No ]

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.
Same as current
Complete list of historical versions of study NCT01216956 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity after treatment [ Time Frame: After 53 days of placebo or nicotinic acid treatment ] [ Designated as safety issue: No ]
    Euglycemic Hyperinsulinemic clamp with glucose tracer infusion
  • Lipoproteins metabolism [ Time Frame: After 53 days of placebo or nicotinic acid treatment ] [ Designated as safety issue: No ]
    Stable Isotopic tracer infusion (d3-leucine, 13C-acétate, d5-glycerol)
  • Lipid profile [ Time Frame: Before and after placebo or nicotinic acid treatment ] [ Designated as safety issue: No ]
    Measure of lipoproteins (VLDL, IDL, LDL, HDL) - characterization of lipoprotein's subfraction Measure of enzymatic activity of cholesteryl ester transfer protein (CETP), phospholipid transfer protein (PLTP) and lecithin cholesterol acyl transferase (LCAT)
Same as current
Not Provided
Not Provided
 
Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
  • Insulin Sensitivity
  • Lipoproteins Metabolism
  • Non Esterified Fatty Acid Kinetics
  • Lipid Profile
Drug: 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.
  • Experimental: Extended release nicotinic acid
    Intervention: Drug: Extended-release nicotinic acid versus placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Extended-release nicotinic acid versus placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2010
June 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01216956
NIASPAN-C05-36
No
Michel Krempf, Institut National de la Santé Et de la Recherche Médicale, France
Centre de Recherche en Nutrition Humaine Rhone-Alpe
  • Institut National de la Santé Et de la Recherche Médicale, France
  • GlaxoSmithKline
Principal Investigator: Michel Krempf, PhD, MD Institut National de la Santé Et de la Recheche Médiacle
Centre de Recherche en Nutrition Humaine Rhone-Alpe
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP