The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)

Study Overview
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Brief Summary
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The aim of the present study is to characterize novel mechanisms whereby HDL may exert potent vasculoprotective effects independent of reverse cholesterol transport, in particular the effect of HDL on the regulation of the vascular NAD(P)H oxidase enzyme system, a major vascular source of superoxide, known to be important for endothelial dysfunction. In addition, the present study will characterize the effect of HDL on endothelial progenitor cell (EPC) mobilization, nitric oxide production and in vivo regenerative capacity.

Official Title
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Randomized Clinical Trial to Study the Effect of Extended Release Niacin on Endothelial Function, Oxidative Stress and Endothelial Progenitor Cells in Patients With the Metabolic Syndrome.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Extended-Release Niacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Statin treatment for at least 3 weeks Reduced HDL: < 40 mg/dL (1.03 mmol/L) in men or < 50 mg/dL (1.29 mmol/L) in women Plus TWO of the following (thereby defining the patients to have metabolic syndrome (Grundy et al.; Circulation 2005)): Elevated waist circumference: ≥ 102 cm (≥ 40 inches) in men or ≥ 88 cm (≥ 35 inches) in women Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L Elevated blood pressure: ≥ 130 mmHg systolic blood pressure or ≥ 80 mmHg diastolic blood pressure or anti-hypertensive treatment Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated fasting glucose Exclusion Criteria: Hypersensitivity to niacin Active liver disease or impaired liver function Persistent elevation of transaminases Cholestasis Gastric ulcer Acute coronary syndrome Gout Pregnancy, lactation Active infections Cancer Untreated concomitant diseases Renal insufficiency or renal failure Hypothyreosis Alcoholism Myopathies Muscle pain under therapy with fibrates or statins Hereditary muscle diseases in family history

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Extended-release Niacin | Drug: Extended-Release Niacin<br>* Extended-Release Niacin tablets week 1-4 500 mg/d week 4-8 1000 mg/d week 9-12 1500 mg/d<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidative Properties of Endothelial Progenitor Cells |  | 3 months | 
| FDD |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Density Lipoprotein (HDL) Elevation |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, High Density Lipoprotein, Extended-Release Niacin, Endothelial Function, Endothelial Progenitor Cells