NCT01119404

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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
6.9 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 11, 2010

Status Verified

May 1, 2010

Enrollment Period

11 years

First QC Date

May 6, 2010

Last Update Submit

May 10, 2010

Conditions

Metabolic SyndromeCoronary Heart Disease

Keywords

Metabolic SyndromeCoronary Heart DiseaseErectile DysfunctionArterial ElasticityOxidized Low Density LipoproteinCardiovascular DiseasesRisk AssessmentEndothelial DysfunctionDiabetes MellitusSurrogate MarkersRisk Factors

Study Arms (3)

Metabolic Syndrome

120 men with metabolic syndrome

Coronary Heart Disease (CHD)

120 men with angiographically verified CHD

Control

80 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: Coronary heart disease (CHD)
  • Finnish men with angiographically proven CHD
  • Age: 30 to 65 years
  • Group 3: Control
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Linnan Klinikka

Hämeenlinna, 13100, Finland

COMPLETED

Mehiläinen Hämeenlinna

Hämeenlinna, 13100, Finland

COMPLETED

Central Hospital of Kanta-Häme

Hämeenlinna, 13530, Finland

RECRUITING

Finnish Red Cross Blood Transfusion Service

Helsinki, 00310, Finland

COMPLETED

Related Publications (3)

  • Saarinen HJ, Lahtela J, Mahonen P, Palomaki A; Hameenlinna Metabolic Syndrome Research Program Study Group. The association between inflammation, arterial stiffness, oxidized LDL and cardiovascular disease in Finnish men with metabolic syndrome - a 15-year follow-up study. BMC Cardiovasc Disord. 2024 Mar 15;24(1):162. doi: 10.1186/s12872-024-03818-x.

    PMID: 38491429DERIVED

  • Pohjantahti-Maaroos H, Palomaki A, Kankkunen P, Husgafvel S, Knuth T, Vesterinen K, Oksanen K. Arterial elasticity and oxidized LDL among men with metabolic syndrome and different 10-year cardiovascular risk estimated by FINRISK and SCORE models. Ann Med. 2012 Aug;44(5):503-12. doi: 10.3109/07853890.2011.590520. Epub 2011 Jul 4.

    PMID: 21726125DERIVED

  • Pohjantahti-Maaroos H, Palomaki A, Hartikainen J. Erectile dysfunction, physical activity and metabolic syndrome: differences in markers of atherosclerosis. BMC Cardiovasc Disord. 2011 Jun 27;11:36. doi: 10.1186/1471-2261-11-36.

    PMID: 21707993DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, EDTA plasma, citrate plasma

MeSH Terms

Conditions

Metabolic SyndromeCoronary DiseaseErectile DysfunctionCardiovascular DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesVascular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersEndocrine 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

Central Study Contacts

Ari K Palomäki, MD PhD

CONTACT

+35836294540ari.palomaki@khshp.fi

Kalevi Oksanen, MD PhD

CONTACT

+35836292369kalevi.oksanen@khshp.fi

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 7, 2010

Study Start

June 1, 2003

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

May 11, 2010

Record last verified: 2010-05

Locations

FI(4)