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

Metabolic Syndrome Clinical Trial

— HMS-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114763
• Other study ID #: KHMetS-01-AP
• Status: Completed
• Phase: N/A
• First received: April 30, 2010
• Last updated: May 3, 2010
• Start date: June 2003
• Est. completion date: September 2007

Study information

• Verified date: April 2010
• Source: Central Hospital of Kanta-Hame
• Contact: n/a
• 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), 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2007
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Locations

Country	Name	City	State
Finland	Central Hospital of Kanta-Häme	Hämeenlinna
Finland	Linnan Klinikka	Hämeenlinna

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital of Kanta-Hame	Linnan Klinikka Oy

Country where clinical trial is conducted

Finland,