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Completed

NCT Number: NCT01114763

Hämeenlinna Metabolic Syndrome Research Program: Oxidized LDL and Arterial Elasticity in Metabolic Syndrome and Controls (HMS-01)

Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS), 40 men with metabolic syndrome and their 40 physically active controls (age: 30 to 65 years) are compared in a cross-sectional study. Except routine laboratory parameters, arterial elasticity and levels of oxidized LDL are determined.

Study hypothesis: Levels of oxidized LDL and findings in arterial elasticity may differ between subjects with metabolic syndrome and controls explaining the elevated risk for cardiovascular diseases among patients with metabolic syndrome.

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Key information

Age range

30 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Central Hospital of Kanta-Häme, Hämeenlinna, Finland

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About this study

Accumulation of oxidized low-density lipoproteins 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. Especially a reduction in the elasticity of small arteries has been found prominent in atherosclerosis and is believed to serve as a marker for early stages of atherosclerosis.

In this study, we investigate whether the levels of oxidized LDL and arterial elasticity differ between patients with metabolic syndrome and their physically active controls. Oxidized LDL is assessed by a two-site ELISA immunoassay (Mercodia, Uppsala, Sweden). The capacitive elasticity of large arteries (C1) and the reflective elasticity of small arteries (C2) are automatically assessed by the CR-2000 as a mean of five most similar pulse waves appearing during the measurement. C1 identifies the elastic properties of aorta and other large arteries, C2 the endothelial function of the microvascular circulation. Proper statistical methods are used to reveal possible differences and their significance between the patients and controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1: Metabolic syndrome

  • 40 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: Control

  • 40 age-matched men
  • Exercise 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

Exclusion criteria

  • Cholesterol-lowering medication
  • ACE-inhibitor medication
  • Angiotensin-receptor blocker medication

Sponsors and collaborators

Lead sponsor

Kanta-Häme Central Hospital

Other Gov

Collaborators

  • Linnan Klinikka Oy

Registry information

Official study title

Hämeenlinna Metabolic Syndrome Research Program (HMS): Comparison of Men With Metabolic Syndrome and Their Physically Active Controls - Circulating Oxidized LDL and Arterial Elasticity

Acronym: HMS-01

Important dates

Study start
2003
Primary completion
2005
Study completion
2007
First posted
May 3, 2010
Registry last updated
May 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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