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

This study is not yet open for participant recruitment.
Verified December 2009 by Glostrup University Hospital, Copenhagen
Sponsor:
Collaborator:
Steno Diabetes Centre, Gentofte, Denmark
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01038518
First received: December 22, 2009
Last updated: December 28, 2009
Last verified: December 2009
History of Changes
  Purpose

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
Cardiovascular Disease
Type 2 Diabetes
Asthma
Allergy
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Urine, serum, whole blood, extracted DNA


Estimated Enrollment: 10000
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Health2010-11
Cross-sectional general population study
5-year follow-up of the Health2006
5-year follow-up examination of the health2006 study population (n=3,471)
Health2012-13
Cross-sectional general population study
Health2014
Cross-sectional general population study
Health2015
Cross-sectional general population study

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
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).

Criteria

Inclusion Criteria:

  • persons living in 10 municipalities of Copenhagen

Exclusion Criteria:

  • pregnancy, non-Danish citizenship
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038518

Contacts
Contact: Allan Linneberg, MD, Phd +45 43233260 alli@glo.regionh.dk

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allan Linneberg, MD, PhD, Research Center for Prevention and Health, Glostrup University Hospital, the Capital Region of Denmark
ClinicalTrials.gov Identifier: NCT01038518     History of Changes
Other Study ID Numbers: H2009124
Study First Received: December 22, 2009
Last Updated: December 28, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Glostrup University Hospital, Copenhagen:
epidemiology
risk factors
micronutrients

Additional relevant MeSH terms:
Asthma
Cardiovascular Diseases
Chronic Disease
Diabetes Mellitus, Type 2
Osteoporosis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013