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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Behavioral: physical exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: physical exercise|8 weeks of regular exercise training|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training |  | before and after 8-weeks exercise training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound |  | before and 8 weeks after exercise training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, HDL-Cholesterol, EPC, endothelial function, reduced blood HDL-Cholesterol level