Clinical trial NCT00346970: The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
High Density Lipoprotein
Extended-Release Niacin
Endothelial Function
Endothelial Progenitor Cells
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Antioxidative Properties of Endothelial Progenitor Cells
timeFrame: 3 months
measure: FDD
timeFrame: 3 months
Secondary outcomes:
measure: High Density Lipoprotein (HDL) Elevation
timeFrame: 3 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Helmut Drexler, MD
role: STUDY_DIRECTOR
affiliation: Hannover Medical School
name: Ulf Landmesser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Sajoscha A Sorrentino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorrentino SA, Besler C, Rohrer L, Meyer M, Heinrich K, Bahlmann FH, Mueller M, Horvath T, Doerries C, Heinemann M, Flemmer S, Markowski A, Manes C, Bahr MJ, Haller H, von Eckardstein A, Drexler H, Landmesser U. Endothelial-vasoprotective effects of high-density lipoprotein are impaired in patients with type 2 diabetes mellitus but are improved after extended-release niacin therapy. Circulation. 2010 Jan 5;121(1):110-22. doi: 10.1161/CIRCULATIONAHA.108.836346. Epub 2009 Dec 21.