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
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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 |
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 |

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. |
- 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.
- Insulin sensitivity after treatment [ Time Frame: After 53 days of placebo or nicotinic acid treatment ]Euglycemic Hyperinsulinemic clamp with glucose tracer infusion
- Lipoproteins metabolism [ Time Frame: After 53 days of placebo or nicotinic acid treatment ]Stable Isotopic tracer infusion (d3-leucine, 13C-acétate, d5-glycerol)
- 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)

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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 |
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

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
France | |
Centre de Recherche en Nutrition Humaine | |
Nantes, France |
Principal Investigator: | Michel Krempf, PhD, MD | Institut National de la Santé Et de la Recheche Médiacle |
Responsible Party: | Michel Krempf, Institut National de la Santé Et de la Recherche Médicale, France |
ClinicalTrials.gov Identifier: | NCT01216956 |
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 |
extended release nicotinic acid non esterified fatty acid (NEFA) insulin resistance Cholesteryl ester transfer protein (CETP) High density lipoprotein cholesterol |
Dyslipidemias Insulin Resistance Obesity, Abdominal Obesity Overnutrition Nutrition Disorders Lipid Metabolism Disorders Metabolic Diseases Hyperinsulinism Glucose Metabolism Disorders Nicotinic Acids |
Niacin Niacinamide Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents |