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

Information source: Hannover Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metabolic Syndrome

Intervention: Extended-Release Niacin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hannover Medical School

Official(s) and/or principal investigator(s):
Helmut Drexler, MD, Study Director, Affiliation: Hannover Medical School
Ulf Landmesser, MD, Principal Investigator, Affiliation: Hannover Medical School
Sajoscha A Sorrentino, MD, Principal Investigator, Affiliation: Hannover Medical School

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.

Clinical Details

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

Primary outcome:

Antioxidative Properties of Endothelial Progenitor Cells

FDD

Secondary outcome: High Density Lipoprotein (HDL) Elevation

Eligibility

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Hannover Medical School, Hannover 30625, Germany
Additional Information

Starting date: July 2006
Last updated: May 5, 2008

Page last updated: August 23, 2015

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