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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Central Hospital of Kanta-Hame.
Recruitment status was  Recruiting
Linnan Klinikka Oy
Mehiläinen Hämeenlinna, Finland
Finnish Red Cross
Information provided by:
Central Hospital of Kanta-Hame
ClinicalTrials.gov Identifier:
First received: May 6, 2010
Last updated: May 10, 2010
Last verified: May 2010
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.

Metabolic Syndrome
Coronary Heart Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Central Hospital of Kanta-Hame:

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

Estimated Enrollment: 300
Study Start Date: June 2003
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Metabolic Syndrome
120 men with metabolic syndrome
Coronary Heart Disease (CHD)
120 men with angiographically verified CHD
80 physically active men

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).


Ages Eligible for Study:   30 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: May 6, 2010
Last Updated: May 10, 2010
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on May 26, 2016