Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346970
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 6, 2008
Information provided by:
Hannover Medical School

Brief Summary:
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 or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Extended-Release Niacin Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : July 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: Placebo
Placebo tablets

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00346970

Layout table for location information
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Layout table for investigator information
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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00346970    
Other Study ID Numbers: 2005-005694-30
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008
Keywords provided by Hannover Medical School:
Metabolic Syndrome
High Density Lipoprotein
Extended-Release Niacin
Endothelial Function
Endothelial Progenitor Cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Physiological Effects of Drugs