Health2016: Monitoring Chronic Disease and Risk Factors i... | NCT02720809

Studies
Health2016: Monitoring Chronic Disease and Risk Factors in the General Population

NCT02720809

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Mar 28, 2016Estimated

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Micronutrient Deficiency
Cardiovascular Disease
Allergy
Respiratory Disease

Interventions

Not provided

Countries

Denmark

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Mar 22, 2016

First Submission Date that Met QC Criteria

Mar 25, 2016

First Posted Date

Mar 28, 2016Estimated

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

Mar 25, 2016

Last Update Posted Date

Mar 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

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

Health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar studies have been performed in 2006, 2010, and 2013.

Detailed Description

A random sample of 18-69 year-olds living in 10 municipalities in the Capital Region of Denmark is invited to a health examination including measurements of anthropometry, lifestyles, symptoms and diagnoses of diseases, blood pressure, resting heart rate, muscle strength, fitness, lung function, allergy tests, and biochemistry (lipids, liver and kidney function, vitamin D status, salt excretion, iodine status). Trends in these parameters over time will be assessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in micronutrient status from 2006 to 2016	Serum 25-OH Vitamin D status (nmol/l) in serum from 2006 to 2016	10 years

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1C from 2006 to 2016	Changes in HbA1C from 2006 to 2016	10
Change in allergic respiratory disease from 2006 to 2016	Changes in prevalence of skin prick test reactivity to inhalant allergens

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years. Danish citizenship, born in Denmark

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Allan Linneberg, MD, PhD	Contact	+45 38633260		allan.linneberg@regionh.dk

Overall Officials

Name	Affiliation	Role
Allan Linneberg, MD, PhD	Center for Health, The Capital Region of Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Centre for Prevention and Health		Copenhagen	Glostrup	DK-2600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D006967	Hypersensitivity
D012120	Respiration Disorders

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided