Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
Information source: Centre de Recherche en Nutrition Humaine Rhone-Alpe
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin Sensitivity; Lipoproteins Metabolism; Non Esterified Fatty Acid Kinetics; Lipid Profile
Intervention: Extended-release nicotinic acid versus placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Centre de Recherche en Nutrition Humaine Rhone-Alpe Official(s) and/or principal investigator(s): Michel Krempf, PhD, MD, Principal Investigator, Affiliation: Institut National de la Santé Et de la Recheche Médiacle
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.
Clinical Details
Official title: Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science
Primary outcome: Evolution of non-esterified fatty acid and triglycerides concentrations over time
Secondary outcome: Insulin sensitivity after treatmentLipoproteins metabolism Lipid profile
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
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
Locations and Contacts
Centre de Recherche en Nutrition Humaine, Nantes, France
Additional Information
Starting date: September 2006
Last updated: October 6, 2010
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