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Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis (HMS-02)

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ClinicalTrials.gov Identifier: NCT01119404
Recruitment Status : Unknown
Verified May 2010 by Central Hospital of Kanta-Hame.
Recruitment status was:  Recruiting
First Posted : May 7, 2010
Last Update Posted : May 11, 2010
Information provided by:

Study Description
Brief Summary:
Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart disease and 80 physically active controls and in different settings.

Condition or disease
Metabolic Syndrome Coronary Heart Disease

Detailed Description:

Accumulation of oxidized low-density lipoproteins (LDL) in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Surrogate indicators of atherosclerosis might be seen already in the early phase of otherwise subclinical arterial disease.

In this study, we investigate calculated risk of the subjects (SCORE, FINRISK, Framingham score), platelet function and surrogate indicators for atherosclerosis like erectile dysfunction, plasma levels of oxidized LDL, arterial elasticity and biochemical markers for endothelial damage and dysfunction in different settings (case-only and case-control).

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Cross-Sectional
Official Title: Hämeenlinna Metabolic Syndrome Research Program (HMS): Surrogate Indicators for Atherosclerosis in Men With Metabolic Syndrome, Coronary Heart Disease and Controls
Study Start Date : June 2003
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Groups and Cohorts

Metabolic Syndrome
120 men with metabolic syndrome
Coronary Heart Disease (CHD)
120 men with angiographically verified CHD
80 physically active men

Outcome Measures

Biospecimen Retention:   Samples Without DNA
serum, EDTA plasma, citrate plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

Group 1: Metabolic syndrome

  • 120 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III
  • MetS diagnosed in routine health examination and laboratory tests
  • Age: 30 to 65 years

Group 2: Coronary heart disease (CHD)

  • 120 Finnish men with angiographically proven CHD
  • Age: 30 to 65 years

Group 3: Control

  • 80 Finnish men
  • Exercising physically more than three times a week and more than 30 minutes per exercise on regular basis
  • Never been studied or treated because of cardiovascular disease
  • Age: 30 to 65 years
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119404

Contact: Ari K Palomäki, MD PhD +35836294540 ari.palomaki@khshp.fi
Contact: Kalevi Oksanen, MD PhD +35836292369 kalevi.oksanen@khshp.fi

Finnish Red Cross Blood Transfusion Service Completed
Helsinki, Finland, 00310
Linnan Klinikka Completed
Hämeenlinna, Finland, 13100
Mehiläinen Hämeenlinna Completed
Hämeenlinna, Finland, 13100
Central Hospital of Kanta-Häme Recruiting
Hämeenlinna, Finland, 13530
Contact: Ari K Palomäki, MD PhD    +35836294540    ari.palomaki@khshp.fi   
Contact: Kalevi Oksanen, MD PhD    +35836292369    kalevi.oksanen@khshp.fi   
Sub-Investigator: Hanna P Pohjantähti-Maaroos, MD         
Sub-Investigator: Sari Husgafvel, MSc         
Sub-Investigator: Päivi Kankkunen, MSc         
Principal Investigator: Ari K Palomäki, MD PhD         
Principal Investigator: Kalevi Oksanen, MD PhD         
Sponsors and Collaborators
Central Hospital of Kanta-Hame
Linnan Klinikka Oy
Mehiläinen Hämeenlinna, Finland
Finnish Red Cross
Study Director: Ari K Palomäki, MD PhD Central Hospital of Kanta-Häme
Study Director: Kalevi Oksanen, MD PhD Central Hospital of Kanta-Häme
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ari Palomäki, MD PhD, Central Hospital of Kanta-Häme
ClinicalTrials.gov Identifier: NCT01119404     History of Changes
Other Study ID Numbers: KHMetS-02-AP
HMS-02 ( Other Identifier: Ethics Committee )
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: May 11, 2010
Last Verified: May 2010

Keywords provided by Central Hospital of Kanta-Hame:
Metabolic Syndrome
Coronary Heart Disease
Erectile Dysfunction
Arterial Elasticity
Oxidized Low Density Lipoprotein
Cardiovascular Diseases
Risk Assessment
Endothelial Dysfunction
Diabetes Mellitus
Surrogate Markers
Risk Factors

Additional relevant MeSH terms:
Heart Diseases
Metabolic Syndrome X
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases