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)

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00515476
First received: August 9, 2007
Last updated: June 22, 2010
Last verified: November 2009
  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 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.


Condition Intervention
Metabolic Syndrome X
Behavioral: physical exercise

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


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound [ Time Frame: before and 8 weeks after exercise training ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: physical exercise
    8 weeks of regular exercise training
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00515476

Locations
Germany
Hannover Medical School
Hannover, Germany
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 by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pricipal Investigator Prof. Dr. med. H. Drexler, MHH Hannover Medical School
ClinicalTrials.gov Identifier: NCT00515476     History of Changes
Other Study ID Numbers: 4031215
Study First Received: August 9, 2007
Last Updated: June 22, 2010
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

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014