Cardiovascular DiseaseHealth2010-4NCT01038518
Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population
An observational study of Cardiovascular Disease and Type 2 Diabetes, run by Glostrup University Hospital, Copenhagen.
Trial summary
The overall aim of the Health2010-14 is to monitor the prevalence and trends of common chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and eczema) that are often un-diagnosed in the general population as well as biomarkers of micronutrient status. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Cardiovascular Disease, Type 2 Diabetes, Asthma
- How many people
- 1,522 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Aug 2011
- 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 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Random samples of persons living in 10 municipalities in the Western part of the Capital Region of Denmark (Copenhagen).
Who may be able to join
- persons living in 10 municipalities of Copenhagen
Who cannot join
- pregnancy, non-Danish citizenship
About this study
The overall aim of the Health2010-14 is to monitor the prevalence and trends of common chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and eczema) that are often un-diagnosed in the general population as well as biomarkers of micronutrient status. Specific aims include identification of novel lifestyle and genetic risk factors for the above diseases by investigating gene-lifestyle interactions.
Read the detailed description
Over a 5-year period a series of population-based studies are carried out including a total of up to 10,000 persons aged 18-69 years selected from the general population of Copenhagen, Denmark. The study also include a follow-up of a previous population study (the Health2006). Participants complete questionnaires on health, lifestyle, and social factors and undergo a health examination including measurements of metabolic biomarkers, allergy tests, anthropometric measures, bioimpedance, biomarkers of micronutrients, spirometry.
- Conditions
- Cardiovascular Disease, Type 2 Diabetes, Asthma, Allergy, Osteoporosis
- Keywords
- epidemiology, risk factors, micronutrients
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Asthma, Hypersensitivity, Osteoporosis
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 |
|---|---|---|
| Health2010 | Cross-sectional general population study |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year change in prevalence of biomarkers of chronic diseases (e.g. diabetes, asthma, allergy) and micronutrient status (e.g. vitamin D status).
Measured: 5 years
Secondary outcomes (1)
significant interaction (on a additive scale) between Vitamin D status and genetic variants in the Vitamin D receptor in relation to selected chronic disease biomarkers
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Centre, Gentofte, Denmark
- Responsible party
- Principal investigator, Allan Linneberg, Glostrup University Hospital, Copenhagen
- Investigators
- Allan Linneberg, MD, PhD, Study director, Research Center for Prevention and Health, Glostrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038518
- Sponsor's protocol ID
- H2009124
- Acronym
- Health2010-4
- Status last verified
- Jan 2015
- First submitted
- 22 Dec 2009
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population
- ClinicalTrials.gov ID
- NCT01038518
- Acronym / sponsor ID
- Health2010-4 / H2009124
- Conditions
- Cardiovascular Disease, Type 2 Diabetes, Asthma, Allergy, Osteoporosis
- Keywords
- epidemiology, risk factors, micronutrients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,522 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Steno Diabetes Centre, Gentofte, Denmark
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 Dec 2009 (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.
The overall aim of the Health2010-14 is to monitor the prevalence and trends of common chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and eczema) that are often un-diagnosed in the general population as well as biomarkers of micronutrient status. Specific aims include identification of novel lifestyle and genetic risk factors for the above diseases by investigating gene-lifestyle interactions.
Detailed description
Over a 5-year period a series of population-based studies are carried out including a total of up to 10,000 persons aged 18-69 years selected from the general population of Copenhagen, Denmark. The study also include a follow-up of a previous population study (the Health2006). Participants complete questionnaires on health, lifestyle, and social factors and undergo a health examination including measurements of metabolic biomarkers, allergy tests, anthropometric measures, bioimpedance, biomarkers of micronutrients, spirometry.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health2010 | – | –Cross-sectional general population study |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Random samples of persons living in 10 municipalities in the Western part of the Capital Region of Denmark (Copenhagen).
Key inclusion criteria (1 listed)
- persons living in 10 municipalities of Copenhagen
Key exclusion criteria (1 listed)
- pregnancy, non-Danish citizenship
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
5-year change in prevalence of biomarkers of chronic diseases (e.g. diabetes, asthma, allergy) and micronutrient status (e.g. vitamin D status).
Time frame: 5 years
1 secondary outcome
significant interaction (on a additive scale) between Vitamin D status and genetic variants in the Vitamin D receptor in relation to selected chronic disease biomarkers
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- Related InfoLink provided by the sponsor.
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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.
Allan Linneberg, MD, PhD study director
Research Center for Prevention and Health, Glostrup Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Type 2 Diabetes, run by Glostrup University Hospital, Copenhagen.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year change in prevalence of biomarkers of chronic diseases (e.g. diabetes, asthma, allergy) and micronutrient status (e.g. vitamin D status). (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2015.