Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis

Metabolic Syndrome Clinical Trial

— HMS-02  

Official title:

Hämeenlinna Metabolic Syndrome Research Program (HMS): Surrogate Indicators for Atherosclerosis in Men With Metabolic Syndrome, Coronary Heart Disease and Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01119404
• Other study ID #: KHMetS-02-AP
• Secondary ID: HMS-02
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2010
• Last updated: May 10, 2010
• Start date: June 2003
• Est. completion date: December 2014

Study information

• Verified date: May 2010
• Source: Central Hospital of Kanta-Hame
• Contact: Ari K Palomäki, MD PhD
• Phone: +35836294540
• Email: ari.palomaki[@]khshp.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Myocardial Ischemia
• Syndrome

Locations

Country	Name	City	State
Finland	Central Hospital of Kanta-Häme	Hämeenlinna
Finland	Linnan Klinikka	Hämeenlinna
Finland	Mehiläinen Hämeenlinna	Hämeenlinna
Finland	Finnish Red Cross Blood Transfusion Service	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Central Hospital of Kanta-Hame	Finnish Red Cross, Linnan Klinikka Oy, Mehiläinen Hämeenlinna, Finland

Country where clinical trial is conducted

Finland,