Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis (HMS-02)

May 10, 2010 updated by: Kanta-Häme Central Hospital

Hämeenlinna Metabolic Syndrome Research Program (HMS): Surrogate Indicators for Atherosclerosis in Men With Metabolic Syndrome, Coronary Heart Disease and Controls

Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart disease and 80 physically active controls and in different settings.

Study Overview

Status

Unknown

Conditions

Detailed Description

Accumulation of oxidized low-density lipoproteins (LDL) 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. Surrogate indicators of atherosclerosis might be seen already in the early phase of otherwise subclinical arterial disease.

In this study, we investigate calculated risk of the subjects (SCORE, FINRISK, Framingham score), platelet function and surrogate indicators for atherosclerosis like erectile dysfunction, plasma levels of oxidized LDL, arterial elasticity and biochemical markers for endothelial damage and dysfunction in different settings (case-only and case-control).

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00310
        • Completed
        • Finnish Red Cross Blood Transfusion Service
      • Hämeenlinna, Finland, 13100
        • Completed
        • Linnan Klinikka
      • Hämeenlinna, Finland, 13100
        • Completed
        • Mehiläinen Hämeenlinna
      • Hämeenlinna, Finland, 13530
        • Recruiting
        • Central Hospital of Kanta-Häme
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hanna P Pohjantähti-Maaroos, MD
        • Sub-Investigator:
          • Sari Husgafvel, MSc
        • Sub-Investigator:
          • Päivi Kankkunen, MSc
        • Principal Investigator:
          • Ari K Palomäki, MD PhD
        • Principal Investigator:
          • Kalevi Oksanen, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

Group 1: Metabolic syndrome

  • 120 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: Coronary heart disease (CHD)

  • 120 Finnish men with angiographically proven CHD
  • Age: 30 to 65 years

Group 3: Control

  • 80 Finnish men
  • Exercising 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
  • Age: 30 to 65 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Metabolic Syndrome
120 men with metabolic syndrome
Coronary Heart Disease (CHD)
120 men with angiographically verified CHD
Control
80 physically active men

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanta-Häme Central Hospital

Collaborators

Linnan Klinikka Oy
Mehiläinen Hämeenlinna, Finland
Finnish Red Cross

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

May 11, 2010

Last Update Submitted That Met QC Criteria

May 10, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHMetS-02-AP
  • HMS-02 (Other Identifier: Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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