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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Metabolic Syndrome; 120 men with metabolic syndrome
Coronary Heart Disease (CHD); 120 men with angiographically verified CHD
Control; 80 physically active men

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA

serum, EDTA plasma, citrate plasma

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

Finland
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

Investigators

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pohjantähti-Maaroos H, Palomäki A, Kankkunen P, Husgafvel S, Knuth T, Vesterinen K, Oksanen K. Arterial elasticity and oxidized LDL among men with metabolic syndrome and different 10-year cardiovascular risk estimated by FINRISK and SCORE models. Ann Med. 2012 Aug;44(5):503-12. doi: 10.3109/07853890.2011.590520. Epub 2011 Jul 4.

Pohjantähti-Maaroos H, Palomäki A, Hartikainen J. Erectile dysfunction, physical activity and metabolic syndrome: differences in markers of atherosclerosis. BMC Cardiovasc Disord. 2011 Jun 27;11:36. doi: 10.1186/1471-2261-11-36.

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
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:

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