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)

Metabolic Syndrome X Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515476
• Other study ID #: 4031215
• Status: Completed
• Phase: N/A
• First received: August 9, 2007
• Last updated: June 22, 2010
• Start date: June 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2009
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• physical exercise
8 weeks of regular exercise training

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound		before and 8 weeks after exercise training	No