Effect of Exercise Training on the Function of the HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Metabolic Syndrome(HERMET-Study)

This study is currently recruiting participants.

Verified by Hannover Medical School, June 2007

First Received: August 9, 2007 No Changes Posted

Sponsored by:	Hannover Medical School
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00515476

Purpose

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 we 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.

Condition	Intervention
Metabolic Syndrome X	Behavioral: physical exercise

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Exercise and Physical Fitness Metabolic Syndrome

Drug Information available for: Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

Primary: vasculoprotective and regenerative functions of HDL-Cholesterol before and after 8-weeks exercise training

Secondary Outcome Measures:

Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound

Study Start Date:	June 2007
Estimated Study Completion Date:	June 2008

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515476

Locations

Germany
Hannover Medical School	Recruiting
Hannover, Germany
Contact: Ulf Landmesser, MD +49511532 ext 2229 Landmesser.Ulf@MH-Hannover.de
Contact: Kristina Sonnenschein, MD +49511532 ext 5402 Sonnenschein.Kristina@MH-Hannover.de
Principal Investigator: Ulf Landmesser, MD

Sponsors and Collaborators

Hannover Medical School

Investigators

Study Director:	Helmut Drexler, MD	Hannover Medical School
Principal Investigator:	Kristina Sonnenschein, MD	Hannover Medical School
Principal Investigator:	Ulf Landmesser, MD	Hannover Medical School

More Information

No publications provided

Study ID Numbers:	4031215
Study First Received:	August 9, 2007
Last Updated:	August 9, 2007
ClinicalTrials.gov Identifier:	NCT00515476 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:

metabolic syndrome
HDL-Cholesterol
EPC
endothelial function
reduced blood HDL-Cholesterol level

Study placed in the following topic categories:

Hyperinsulinism
Metabolic Diseases
Metabolic Syndrome X
Stress

Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Abdominal Obesity Metabolic Syndrome

Additional relevant MeSH terms:

Hyperinsulinism
Metabolic Diseases
Pathologic Processes
Disease

Metabolic Syndrome X
Syndrome
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 04, 2009