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

This study has been completed.
Sponsor:
Collaborator:
Linnan Klinikka Oy
Information provided by:
Central Hospital of Kanta-Hame
ClinicalTrials.gov Identifier:
NCT01114763
First received: April 30, 2010
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

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.


Condition
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Central Hospital of Kanta-Hame:

Biospecimen Retention:   Samples Without DNA

serum, EDTA plasma, citrate plasma


Enrollment: 80
Study Start Date: June 2003
Study Completion Date: September 2007
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
Metabolic syndrome
40 men with metabolic syndrome
Control
40 physically active men

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114763

Locations
Finland
Central Hospital of Kanta-Häme
Hämeenlinna, Finland, 13530
Linnan Klinikka
Hämeenlinna, Finland, 13100
Sponsors and Collaborators
Central Hospital of Kanta-Hame
Linnan Klinikka Oy
Investigators
Study Director: Ari K Palomäki, MD PhD Central Hospital of Kanta-Häme
Study Director: Kalevi Oksanen, MD PhD Central Hospital of Kanta-Häme
  More Information

No publications provided by Central Hospital of Kanta-Hame

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ari Palomäki, MD PhD, Head of department, Central Hospital of Kanta-Häme, Hämeenlinna, Finland
ClinicalTrials.gov Identifier: NCT01114763     History of Changes
Other Study ID Numbers: KHMetS-01-AP
Study First Received: April 30, 2010
Last Updated: May 3, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by Central Hospital of Kanta-Hame:
Metabolic Syndrome
Oxidized Low Density Lipoprotein
Arterial Elasticity
Diabetes Mellitus
Cardiovascular Diseases

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014