NCT00346970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 6, 2008

Status Verified

May 1, 2008

First QC Date

June 30, 2006

Last Update Submit

May 5, 2008

Conditions

Metabolic Syndrome

Keywords

Metabolic SyndromeHigh Density LipoproteinExtended-Release NiacinEndothelial FunctionEndothelial Progenitor Cells

Outcome Measures

Primary Outcomes (2)

  • Antioxidative Properties of Endothelial Progenitor Cells

    3 months

  • FDD

    3 months

Secondary Outcomes (1)

  • High Density Lipoprotein (HDL) Elevation

    3 months

Study Arms (2)

1

EXPERIMENTAL

Extended-release Niacin

Drug: Extended-Release Niacin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Extended-Release NiacinDRUG

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

1
PlaceboDRUG

Placebo tablets

2

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20026785DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Helmut Drexler, MD

    Hannover Medical School

    STUDY DIRECTOR

  • Ulf Landmesser, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

  • Sajoscha A Sorrentino, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

July 1, 2006

Study Completion

July 1, 2007

Last Updated

May 6, 2008

Record last verified: 2008-05

Locations

DE(1)