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

NCT ID: NCT00346970

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome

Keywords

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Metabolic Syndrome High Density Lipoprotein Extended-Release Niacin Endothelial Function Endothelial Progenitor Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Extended-release Niacin

Group Type EXPERIMENTAL

Extended-Release Niacin

Intervention Type DRUG

Extended-Release Niacin tablets week 1-4 500 mg/d week 4-8 1000 mg/d week 9-12 1500 mg/d

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets

Interventions

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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

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Principal Investigators

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Helmut Drexler, MD

Role: STUDY_DIRECTOR

Hannover Medical School

Ulf Landmesser, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Sajoscha A Sorrentino, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 20026785 (View on PubMed)

Other Identifiers

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2005-005694-30

Identifier Type: -

Identifier Source: org_study_id