Back to resultsThe High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Extended-Release Niacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, High Density Lipoprotein, Extended-Release Niacin, Endothelial Function, Endothelial Progenitor Cells
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
Sites / Locations
- Hannover Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Extended-release Niacin
Placebo
Outcomes
Primary Outcome Measures
Antioxidative Properties of Endothelial Progenitor Cells
FDD
Secondary Outcome Measures
High Density Lipoprotein (HDL) Elevation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00346970
Brief Title
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
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, High Density Lipoprotein, Extended-Release Niacin, Endothelial Function, Endothelial Progenitor Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Extended-release Niacin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Extended-Release Niacin
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Antioxidative Properties of Endothelial Progenitor Cells
Time Frame
3 months
Title
FDD
Time Frame
3 months
Secondary Outcome Measure Information:
Title
High Density Lipoprotein (HDL) Elevation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Drexler, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ulf Landmesser, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sajoscha A Sorrentino, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20026785
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.
Results Reference
derived
Learn more about this trial
The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)
We'll reach out to this number within 24 hrs