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NCT Number: NCT00346970

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hannover Medical School

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended-Release Niacin

Drug

Extended-Release Niacin tablets week 1-4 500 mg/d week 4-8 1000 mg/d week 9-12 1500 mg/d

Placebo

Drug

Placebo tablets

Primary outcomes

  1. Antioxidative Properties of Endothelial Progenitor Cells

    Time frame: 3 months

  2. FDD

    Time frame: 3 months

Secondary outcomes

  1. High Density Lipoprotein (HDL) Elevation

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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.

Important dates

Study start
2006
Study completion
2007
First posted
Jul 4, 2006
Registry last updated
May 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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