Health2010-14: Monitoring Biomarkers of Chronic Diseases... | NCT01038518

Studies
Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population

NCT01038518

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Jan 22, 2015Estimated

Enrollment

1,522Actual

Phase

Not provided

Conditions

Cardiovascular Disease
Type 2 Diabetes
Asthma
Allergy
Osteoporosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 22, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2015

Last Update Posted Date

Jan 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Allan Linneberg, Professor, Head of Section, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Name	Class
Steno Diabetes Centre, Gentofte, Denmark	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,522Actual

Label	Type	Description	Intervention Names
Health2010		Cross-sectional general population study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5-year change in prevalence of biomarkers of chronic diseases (e.g. diabetes, asthma, allergy) and micronutrient status (e.g. vitamin D status).		5 years

Secondary Outcomes

Measure	Description	Time Frame
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		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

persons living in 10 municipalities of Copenhagen

Exclusion Criteria:

pregnancy, non-Danish citizenship

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Random samples of persons living in 10 municipalities in the Western part of the Capital Region of Denmark (Copenhagen).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan Linneberg, MD, PhD	Research Center for Prevention and Health, Glostrup Hospital	Study Director

Locations

Not provided

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D003924	Diabetes Mellitus, Type 2
D001249	Asthma
D006967	Hypersensitivity
D010024	Osteoporosis

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided