NCT01114763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed
Last Updated

May 4, 2010

Status Verified

April 1, 2010

Enrollment Period

2.4 years

First QC Date

April 30, 2010

Last Update Submit

May 3, 2010

Conditions

Keywords

Metabolic SyndromeOxidized Low Density LipoproteinArterial ElasticityDiabetes MellitusCardiovascular Diseases

Study Arms (2)

Metabolic syndrome

40 men with metabolic syndrome

Control

40 physically active men

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic.

You may qualify if:

  • Group 1: Metabolic syndrome
  • 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
  • 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

You may not qualify if:

  • Cholesterol-lowering medication
  • ACE-inhibitor medication
  • Angiotensin-receptor blocker medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linnan Klinikka

Hämeenlinna, 13100, Finland

Location

Central Hospital of Kanta-Häme

Hämeenlinna, 13530, Finland

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, EDTA plasma, citrate plasma

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ari K Palomäki, MD PhD

    Central Hospital of Kanta-Häme

    STUDY DIRECTOR
  • Kalevi Oksanen, MD PhD

    Central Hospital of Kanta-Häme

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 3, 2010

Study Start

June 1, 2003

Primary Completion

November 1, 2005

Study Completion

September 1, 2007

Last Updated

May 4, 2010

Record last verified: 2010-04

Locations