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Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population (Health2010-4)

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ClinicalTrials.gov Identifier: NCT01038518
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : January 22, 2015
Information provided by (Responsible Party):

Study Description
Brief 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. Specific aims include identification of novel lifestyle and genetic risk factors for the above diseases by investigating gene-lifestyle interactions.

Condition or disease
Cardiovascular Disease Type 2 Diabetes Asthma Allergy Osteoporosis

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

Study Type : Observational
Actual Enrollment : 1522 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population
Study Start Date : November 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Cross-sectional general population study

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Urine, serum, whole blood, extracted DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Random samples of persons living in 10 municipalities in the Western part of the Capital Region of Denmark (Copenhagen).

Inclusion Criteria:

  • persons living in 10 municipalities of Copenhagen

Exclusion Criteria:

  • pregnancy, non-Danish citizenship
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038518

Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Steno Diabetes Centre, Gentofte, Denmark
Study Director: Allan Linneberg, MD, PhD Research Center for Prevention and Health, Glostrup Hospital
More Information

Additional Information:
Responsible Party: Allan Linneberg, Professor, Head of Section, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01038518     History of Changes
Other Study ID Numbers: H2009124
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Allan Linneberg, Glostrup University Hospital, Copenhagen:
risk factors

Additional relevant MeSH terms:
Cardiovascular Diseases
Chronic Disease
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Disease Attributes
Pathologic Processes