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

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT01114763
• 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), 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.

Detailed 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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-11
• Study Completion: 2007-09
• Status Verified: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Last Update Submitted: 2010-05-03
• Last Update Posted: 2010-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

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

Linnan Klinikka; 🇫🇮 Hämeenlinna, Finland