- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01942291
Short-term Effect of Extended-release Niacin on Endothelial Function.
Short-term Effect of Extended-release Niacin With and Without the Addition of Laropiprant on Endothelial Function
Study Overview
Detailed Description
Study design and treatments The study was randomized, double-blind, controlled, using a 2-way crossover design with both treatment periods and washout time lasting 7 days. Subjects were allocated by simple randomization to extended-release niacin 1g/day alone (ERN, Metri, Libbs Farmacêutica, São Paulo, Brazil) or niacin associated with LRPT 1g/20mg (ERN/LRPT, Cordaptive, Merck, São Paulo, Brazil). Medications were kindly supplied by Libbs and Merck. Plasma samples and brachial artery reactivity were obtained at baseline, 7th day of treatment 1, 7th day after washout and 7th day of treatment 2.
Study Measurements The following blood measurements were performed using the Modular Hitachi system and Roche Diagnostics (Mannheim, Germany) reagents: glucose (GOD-PAP), triglycerides (TG)(GPO-PAP), HDL-C (HDL-C plus 3rd generation) and C-reactive protein (CRP) (high-sensitivity CRP, Cardiophase, Dade Behring, Marburg, Germany). LDL cholesterol was calculated by the Friedewald formula. HDL size was measured by laser scattering (Zetasizer - Nanoseries DTS 1060, Malvern Instruments, Worcestershire, UK). Total and direct bilirrubin was measured by the Jendrassik-Grof method (Roche/Hitachi analyzer).
The cholesteryl ester transfer protein activity was measured by an endogenous assay. Aliquots of the whole plasma (in which LCAT activity was inhibited by DTNB 9 μL/mL) were added to HDL-[3H]cholesteryl ester fractions and simultaneously incubated at 4°C and 37°C for 4h. Apo-B containing lipoproteins, present in the incubation mixture, were then precipitated; the CE radioactivity in the supernatant represented the net rate at which CE mass was transferred and values expressed as percent of [3H] cholesteryl ester transferred/4 hours depended upon the plasma concentrations of HDL, TG-rich lipoproteins and CETP simultaneously.
Endothelial-dependent vasodilation was assessed by ischemia-induced reactive hyperemia. Briefly, after 12-hour overnight fasting patients were examined at 8 a.m. in a quiet room at 22ºC by using a ultrasound equipment Vivid i (GE Healthcare, Wauwatosa, WI, USA) with a high-resolution (up to 13 MHz) vascular probe (12l-RS, GE Healthcare, Wauwatosa, WI, USA) in B-mode. The cardiac cycles were monitored simultaneously by electrocardiography coupled to the equipment. Flow-mediated dilation (FMD) was assessed after 5-minutes inflation of a cuff placed below the transducer, 50 mm Hg above the systolic blood pressure. Two-dimensional images of the brachial artery were obtained during 5 minutes from the longitudinal axis approximately 5-10 cm above the antecubital fossa. The maximum expansion of the diameter of the brachial artery was measured in triplicate at the peak of the T wave of the cardiac cycle before the interruption of the flow and post deflation.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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SP
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Campinas, SP, Brazil, 13083-887
- University of Campinas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- asymptomatic individuals
- plasma HDL-C levels <40 mg/dL
Exclusion Criteria:
- symptomatic atherosclerotic disease
- diabetes
- liver disease
- renal disease
- thyroid dysfunction
- indication for or use of lipid-lowering treatment in the last six months
- use of anti-inflammatory treatment in the last 30 days
- current or previous diagnosis of cancer or immune inflammatory diseases
- chronic obstructive pulmonary disease
- infectious disease manifested in the last 3 months
- body mass index ≥ 26 kg/m2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Niacin/Laropiprant
Extended-release niacin 1g/day associated with Laropiprant 1g/20mg (ERN/LRPT, Cordaptive, Merck, Sao Paulo, Brazil)
|
The study was randomized, double-blind, controlled, using a 2-way crossover design with both treatment periods and washout time lasting 7 days.
Subjects were allocated by simple randomization to extended-release niacin 1g/day alone (ERN, Metri, Libbs Farmacêutica, São Paulo, Brazil) or niacin associated with LRPT 1g/20mg (ERN/LRPT, Cordaptive, Merck, São Paulo, Brazil).
Other Names:
|
Experimental: Niacin
Extended-release niacin 1g/day alone (ERN, Metri, Libbs Farmaceutica, Sao Paulo, Brazil)
|
The study was randomized, double-blind, controlled, using a 2-way crossover design with both treatment periods and washout time lasting 7 days.
Subjects were allocated by simple randomization to extended-release niacin 1g/day alone (ERN, Metri, Libbs Farmacêutica, São Paulo, Brazil) or niacin associated with LRPT 1g/20mg (ERN/LRPT, Cordaptive, Merck, São Paulo, Brazil).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The short-term effect of niacin on endothelial function.
Time Frame: 7 days
|
Endothelial-dependent vasodilation was assessed by ischemia-induced reactive hyperemia of the brachial artery by using an ultrasound equipment
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma C-reactive protein levels
Time Frame: 7 days
|
Systemic inflammatory activity as estimated by the plasma concentration of C-reactive protein
|
7 days
|
HDL-C and HDL size
Time Frame: 7 days
|
Plasma concentration of high-density lipoprotein (HDL) cholesterol and HDL size
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrei C Sposito, PhD, University of Campinas
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hypolipoproteinemias
- Hypoalphalipoproteinemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Nicotinic Acids
- Niacin
Other Study ID Numbers
- Unicamp845/2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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