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) (HERMET)

June 22, 2010 updated by: Hannover Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
before and after 8-weeks exercise training

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 9, 2007

First Submitted That Met QC Criteria

August 9, 2007

First Posted (Estimate)

August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

June 22, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4031215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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