Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis

• Conditions: Metabolic Syndrome; Coronary Heart Disease

• Registration Number: NCT01119404
• Lead Sponsor: Kanta-Häme Central Hospital

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.

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 Timeline

• Study Start: 2003-06
• Status Verified: 2010-05
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Last Update Submitted: 2010-05-10
• Last Update Posted: 2010-05-11
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Finnish Red Cross Blood Transfusion Service; 🇫🇮 Helsinki, Finland

Linnan Klinikka; 🇫🇮 Hämeenlinna, Finland

Central Hospital of Kanta-Häme; 🇫🇮 Hämeenlinna, Finland

Mehiläinen Hämeenlinna; 🇫🇮 Hämeenlinna, Finland