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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2010 by Central Hospital of Kanta-Hame.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01119404

First Posted: May 7, 2010

Last Update Posted: May 11, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Linnan Klinikka Oy

Mehiläinen Hämeenlinna, Finland

Finnish Red Cross

Information provided by:

Central Hospital of Kanta-Hame

Purpose

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
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:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease Heart Diseases Metabolic Syndrome

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

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)

Groups/Cohorts
Metabolic Syndrome 120 men with metabolic syndrome
Coronary Heart Disease (CHD) 120 men with angiographically verified CHD
Control 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).

Eligibility

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

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

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

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

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 Submitted:	May 6, 2010
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

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