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

K

Kanta-Häme Central Hospital

Status

Unknown

Conditions

Coronary Heart Disease
Metabolic Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT01119404
HMS-02 (Other Identifier)
KHMetS-02-AP

Details and patient eligibility

About

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.

Full 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).

Enrollment

300 estimated patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 3 patient groups

Metabolic Syndrome
Description:
120 men with metabolic syndrome
Coronary Heart Disease (CHD)
Description:
120 men with angiographically verified CHD
Control
Description:
80 physically active men

Trial contacts and locations

4

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Central trial contact

Kalevi Oksanen, MD PhD; Ari K Palomäki, MD PhD

Data sourced from clinicaltrials.gov

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