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

Metabolic Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346970
• Other study ID #: 2005-005694-30
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2006
• Last updated: May 5, 2008
• Start date: July 2006
• Est. completion date: July 2007

Study information

• Verified date: May 2008
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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
Placebo tablets

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antioxidative Properties of Endothelial Progenitor Cells		3 months
Primary	FDD		3 months
Secondary	High Density Lipoprotein (HDL) Elevation		3 months