Metabolic SyndromeHMS-02NCT01119404
Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis
An observational study of Metabolic Syndrome and Coronary Heart Disease, run by Kanta-Häme Central Hospital at 4 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Coronary Heart Disease
- How many people
- 300 participants
- Where
- 4 sitesFinland
- Study dates
- Jun 2003to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Finland4 sites, 1 recruiting
- Completed
Linnan Klinikka
Hämeenlinna, 13100
- Completed
Mehiläinen Hämeenlinna
Hämeenlinna, 13100
- Recruiting
Central Hospital of Kanta-Häme
Hämeenlinna, 13530
Ari K Palomäki, MD PhD, +35836294540, ari.palomaki@khshp.fi
Kalevi Oksanen, MD PhD, +35836292369, kalevi.oksanen@khshp.fi
- Completed
Finnish Red Cross Blood Transfusion Service
Helsinki, 00310
About this study
Official title: 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.
Read the 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).
- Conditions
- Metabolic Syndrome, Coronary Heart Disease
- Keywords
- Metabolic Syndrome, Coronary Heart Disease, Erectile Dysfunction, Arterial Elasticity, Oxidized Low Density Lipoprotein, Cardiovascular Diseases, Risk Assessment, Endothelial Dysfunction, Diabetes Mellitus, Surrogate Markers, Risk Factors
- Medical subject headings
- Metabolic Syndrome, Coronary Disease, Erectile Dysfunction, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Syndrome | 120 men with metabolic syndrome | |
| Coronary Heart Disease (CHD) | 120 men with angiographically verified CHD | |
| Control | 80 physically active men |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startJun 2003
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanta-Häme Central Hospital
- Sponsor type
- Other government
- Collaborators
- Linnan Klinikka Oy, Mehiläinen Hämeenlinna, Finland, Finnish Red Cross Blood Service
- Investigators
- Ari K Palomäki, MD PhD, Study director, Central Hospital of Kanta-HämeKalevi Oksanen, MD PhD, Study director, Central Hospital of Kanta-Häme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119404
- Sponsor's protocol ID
- KHMetS-02-AP
- Other IDs
- HMS-02
- Acronym
- HMS-02
- Status last verified
- May 2010
- First submitted
- 6 May 2010
- Last updated
- 11 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38491429Pohjantahti-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.
PubMed 21726125Pohjantahti-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.
PubMed 21707993
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hämeenlinna Metabolic Syndrome Research Program (HMS): Surrogate Indicators for Atherosclerosis in Men With Metabolic Syndrome, Coronary Heart Disease and Controls
- ClinicalTrials.gov ID
- NCT01119404
- Acronym / sponsor ID
- HMS-02 / KHMetS-02-AP
- Conditions
- Metabolic Syndrome, Coronary Heart Disease
- Keywords
- Metabolic Syndrome, Coronary Heart Disease, Erectile Dysfunction, Arterial Elasticity, Oxidized Low Density Lipoprotein, Cardiovascular Diseases, Risk Assessment, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kanta-Häme Central HospitalOther government
- Collaborators
- Linnan Klinikka Oy, Mehiläinen Hämeenlinna, Finland, Finnish Red Cross Blood Service
- Study start
- Jun 2003
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metabolic Syndrome | – | –120 men with metabolic syndrome |
| Coronary Heart Disease (CHD) | – | –120 men with angiographically verified CHD |
| Control | – | –80 physically active men |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
- Derived from this study: PubMed 38491429Saarinen 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.
- Derived from this study: PubMed 21726125Pohjantahti-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.
- Derived from this study: PubMed 21707993Pohjantahti-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari K Palomäki, MD PhD study director
Central Hospital of Kanta-Häme
Kalevi Oksanen, MD PhD study director
Central Hospital of Kanta-Häme
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Coronary Heart Disease, run by Kanta-Häme Central Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ari K Palomäki, MD PhD (+35836294540, ari.palomaki@khshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01119404, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2010.