Clinical trial NCT00515476: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: metabolic syndrome
HDL-Cholesterol
EPC
endothelial function
reduced blood HDL-Cholesterol level
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2007-08-13
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training
timeFrame: before and after 8-weeks exercise training
Secondary outcomes:
measure: Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
timeFrame: before and 8 weeks after exercise training
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Helmut Drexler, MD
role: STUDY_DIRECTOR
affiliation: Hannover Medical School
name: Kristina Sonnenschein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Ulf Landmesser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.