This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Hannover Medical School Identifier:
First received: June 30, 2006
Last updated: May 5, 2008
Last verified: May 2008
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
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

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
Drug: Placebo
Placebo tablets


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00346970

Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00346970     History of Changes
Other Study ID Numbers: 2005-005694-30
Study First Received: June 30, 2006
Last Updated: May 5, 2008

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
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on July 19, 2017