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)

NCT ID: NCT00515476

Last Updated: 2010-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Metabolic Syndrome X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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physical exercise

8 weeks of regular exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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MHH Hannover Medical School

Principal Investigators

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Helmut Drexler, MD

Role: STUDY_DIRECTOR

Hannover Medical School

Kristina Sonnenschein, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Ulf Landmesser, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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Sonnenschein K, Horvath T, Mueller M, Markowski A, Siegmund T, Jacob C, Drexler H, Landmesser U. Exercise training improves in vivo endothelial repair capacity of early endothelial progenitor cells in subjects with metabolic syndrome. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):406-14. doi: 10.1177/1741826710389373. Epub 2011 Feb 11.

Reference Type DERIVED
PMID: 21450652 (View on PubMed)

Other Identifiers

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4031215

Identifier Type: -

Identifier Source: org_study_id

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