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

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ClinicalTrials.gov Identifier: NCT01216956
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : October 7, 2010
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Lipoproteins Metabolism Non Esterified Fatty Acid Kinetics Lipid Profile Drug: Extended-release nicotinic acid versus placebo Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Basic Science
Official Title: Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
Study Start Date : September 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : March 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Extended release nicotinic acid 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.
Placebo Comparator: Placebo 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.


Outcome Measures
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Primary Outcome Measures :
  1. Evolution of non-esterified fatty acid and triglycerides concentrations over time [ Time Frame: After 42 and 56 days of placebo or nicotinic acid treatment ]

    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.


Secondary Outcome Measures :
  1. Insulin sensitivity after treatment [ Time Frame: After 53 days of placebo or nicotinic acid treatment ]
    Euglycemic Hyperinsulinemic clamp with glucose tracer infusion

  2. Lipoproteins metabolism [ Time Frame: After 53 days of placebo or nicotinic acid treatment ]
    Stable Isotopic tracer infusion (d3-leucine, 13C-acétate, d5-glycerol)

  3. Lipid profile [ Time Frame: Before and after placebo or nicotinic acid treatment ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216956


Locations
France
Centre de Recherche en Nutrition Humaine
Nantes, France
Sponsors and Collaborators
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Institut National de la Santé Et de la Recherche Médicale, France
GlaxoSmithKline
Investigators
Principal Investigator: Michel Krempf, PhD, MD Institut National de la Santé Et de la Recheche Médiacle
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michel Krempf, Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01216956     History of Changes
Other Study ID Numbers: NIASPAN-C05-36
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: October 2010

Keywords provided by Centre de Recherche en Nutrition Humaine Rhone-Alpe:
extended release nicotinic acid
non esterified fatty acid (NEFA)
insulin resistance
Cholesteryl ester transfer protein (CETP)
High density lipoprotein cholesterol

Additional relevant MeSH terms:
Dyslipidemias
Insulin Resistance
Obesity, Abdominal
Lipid Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Obesity
Overnutrition
Nutrition Disorders
Niacin
Nicotinic Acids
 Niacinamide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs