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

Hannover Medical School (MHH)

Status and phase

Completed

Phase 4

Conditions

Metabolic Syndrome

Treatments

Drug: Placebo

Drug: Extended-Release Niacin

Study type

Interventional

Funder types

Other

Identifiers

NCT00346970

2005-005694-30

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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