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

NCT ID: NCT01114763

Last Updated: 2010-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Metabolic syndrome

40 men with metabolic syndrome

No interventions assigned to this group

Control

40 physically active men

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Linnan Klinikka Oy

OTHER

Sponsor Role collaborator

Kanta-Häme Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Central Hospital of Kanta-Häme, Hämeenlinna, Finland

Principal Investigators

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Ari K Palomäki, MD PhD

Role: STUDY_DIRECTOR

Central Hospital of Kanta-Häme

Kalevi Oksanen, MD PhD

Role: STUDY_DIRECTOR

Central Hospital of Kanta-Häme

Locations

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Linnan Klinikka

Hämeenlinna, , Finland

Site Status

Central Hospital of Kanta-Häme

Hämeenlinna, , Finland

Site Status

Countries

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Finland

References

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Pohjantahti-Maaroos H, Palomaki A, Kankkunen P, Laitinen R, Husgafvel S, Oksanen K. Circulating oxidized low-density lipoproteins and arterial elasticity: comparison between men with metabolic syndrome and physically active counterparts. Cardiovasc Diabetol. 2010 Aug 20;9:41. doi: 10.1186/1475-2840-9-41.

Reference Type DERIVED
PMID: 20727144 (View on PubMed)

Other Identifiers

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KHMetS-01-AP

Identifier Type: -

Identifier Source: org_study_id

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