Effect of Exercise Training on the Function of the High Density Lipoprotein (HDL)-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Metabolic Syndrome(HERMET-Study) (HERMET)
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
physical exercise
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome X focused on measuring metabolic syndrome, HDL-Cholesterol, EPC, endothelial function, reduced blood HDL-Cholesterol level
Eligibility Criteria
Inclusion Criteria:
- Reduced HDL-Cholesterol levels in blood: < 40 mg/dl (1.03 mmol/L) in male, < 50 mg/dl (1.29 mmol/L) in female
- Plus two of the following criteria:
- 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:
- Acute coronary syndrome
- Unstable Angina pectoris
- Myocardial infarction during the last 8 weeks
- Therapy with Niacin
- Active infections
- Ventricular arrhythmias
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg
- Cancer
- Pregnancy, lactation
- Alcoholism
Sites / Locations
- Hannover Medical School
Outcomes
Primary Outcome Measures
Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training
Secondary Outcome Measures
Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00515476
Brief Title
Effect of Exercise Training on the Function of the High Density Lipoprotein (HDL)-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Metabolic Syndrome(HERMET-Study)
Acronym
HERMET
Official Title
Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
4. Oversight
5. Study Description
Brief Summary
The purpose of the present study is to characterize the quality of HDL-Cholesterol in patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these patients. Additionally the investigators aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with metabolic syndrome and the changes dependent on physical activity of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
metabolic syndrome, HDL-Cholesterol, EPC, endothelial function, reduced blood HDL-Cholesterol level
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
physical exercise
Intervention Description
8 weeks of regular exercise training
Primary Outcome Measure Information:
Title
Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training
Time Frame
before and after 8-weeks exercise training
Secondary Outcome Measure Information:
Title
Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
Time Frame
before and 8 weeks after exercise training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Reduced HDL-Cholesterol levels in blood: < 40 mg/dl (1.03 mmol/L) in male, < 50 mg/dl (1.29 mmol/L) in female
Plus two of the following criteria:
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:
Acute coronary syndrome
Unstable Angina pectoris
Myocardial infarction during the last 8 weeks
Therapy with Niacin
Active infections
Ventricular arrhythmias
Systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg
Cancer
Pregnancy, lactation
Alcoholism
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
Kristina Sonnenschein, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulf Landmesser, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21450652
Citation
Sonnenschein K, Horvath T, Mueller M, Markowski A, Siegmund T, Jacob C, Drexler H, Landmesser U. Exercise training improves in vivo endothelial repair capacity of early endothelial progenitor cells in subjects with metabolic syndrome. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):406-14. doi: 10.1177/1741826710389373. Epub 2011 Feb 11.
Results Reference
derived
Learn more about this trial
Effect of Exercise Training on the Function of the High Density Lipoprotein (HDL)-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Metabolic Syndrome(HERMET-Study)
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