Clinical trial NCT01119404: Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis
Official title: Hämeenlinna Metabolic Syndrome Research Program (HMS): Surrogate Indicators for Atherosclerosis in Men With Metabolic Syndrome, Coronary Heart Disease and Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Coronary Heart Disease
Keywords: 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
Lead sponsor: Kanta-Häme Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Linnan Klinikka Oy
name: Mehiläinen Hämeenlinna, Finland
name: Finnish Red Cross Blood Service
First posted: 2010-05-07
Enrollment: 300
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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).

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Red Cross Blood Transfusion Service
city: Hämeenlinna
country: Finland
facility: Linnan Klinikka
city: Hämeenlinna
country: Finland
facility: Mehiläinen Hämeenlinna
city: Hämeenlinna
country: Finland
facility: Central Hospital of Kanta-Häme
Study officials:
affiliation: Central Hospital of Kanta-Häme
name: Ari K Palomäki, MD PhD
role: STUDY_DIRECTOR
affiliation: Central Hospital of Kanta-Häme
name: Kalevi Oksanen, MD PhD
role: STUDY_DIRECTOR
References:
citation: Pohjantahti-Maaroos H, Palomaki 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.
citation: Pohjantahti-Maaroos H, Palomaki 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.