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

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00346970
First received: June 30, 2006
Last updated: May 5, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
 Drug: Extended-Release Niacin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Antioxidative Properties of Endothelial Progenitor Cells [ Time Frame: 3 months ]
  • FDD [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • High Density Lipoprotein (HDL) Elevation [ Time Frame: 3 months ]

Enrollment: 32
Study Start Date: July 2006
Study Completion Date: July 2007
Arms Assigned Interventions
Experimental: 1
Extended-release Niacin
 Drug: Extended-Release Niacin
Extended-Release Niacin tablets week 1-4 500 mg/d week 4-8 1000 mg/d week 9-12 1500 mg/d
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo tablets

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346970

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Study Director: Helmut Drexler, MD Hannover Medical School
Principal Investigator: Ulf Landmesser, MD Hannover Medical School
Principal Investigator: Sajoscha A Sorrentino, MD Hannover Medical School
  More Information

No publications provided by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00346970     History of Changes
Other Study ID Numbers: 2005-005694-30
Study First Received: June 30, 2006
Last Updated: May 5, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Metabolic Syndrome
High Density Lipoprotein
Extended-Release Niacin
Endothelial Function
Endothelial Progenitor Cells

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Niacin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013