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)

Not Applicable

Completed

• Conditions: Metabolic Syndrome X

• Registration Number: NCT00515476
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-08-09
• Study First Submitted QC: 2007-08-09
• Study First Posted: 2007-08-13
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Status Verified: 2009-11
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound	before and 8 weeks after exercise training

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany