Clinical trial NCT01114763: Hämeenlinna Metabolic Syndrome Research Program: Oxidized LDL and Arterial Elasticity in Metabolic Syndrome and Controls (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Oxidized Low Density Lipoprotein
Arterial Elasticity
Diabetes Mellitus
Cardiovascular Diseases
Lead sponsor: Kanta-Häme Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Linnan Klinikka Oy
First posted: 2010-05-03
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
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), 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hämeenlinna
country: Finland
facility: Linnan Klinikka
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, 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.