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)

NCT00515476 | Completed

• 1 other identifier: 4031215
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X

Keywords

metabolic syndrome; HDL-Cholesterol; EPC; endothelial function; reduced blood HDL-Cholesterol level

Outcome Measures

Primary Outcomes (1)

• Primary: vasculoprotective and regenerative functions of HDL-Cholesterol and EPC function before and after 8-weeks exercise training

  before and after 8-weeks exercise training

Secondary Outcomes (1)

• Secondary: flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound

  before and 8 weeks after exercise training

Interventions

physical exercise BEHAVIORAL

8 weeks of regular exercise training

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Germany

Location

Related Publications (1)

• 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.

  PMID: 21450652 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helmut Drexler, MD

  Hannover Medical School

  STUDY DIRECTOR

• Kristina Sonnenschein, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

• Ulf Landmesser, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 23, 2010

Record last verified: 2009-11

Locations

DE (1)