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:
Hannover Medical School
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00515476
First received: August 9, 2007
Last updated: June 22, 2010
Last verified: November 2009
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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
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 Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013