Status:
COMPLETED
The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)
Lead Sponsor:
Hannover Medical School
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00346970
Start Date
July 1 2006
End Date
July 1 2007
Last Update
May 6 2008
Active Locations (1)
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1
Hannover Medical School
Hanover, Germany, 30625