Air Pollution and Cardio-metabolic Health | NCT04125212

Studies
Air Pollution and Cardio-metabolic Health

NCT04125212

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Sep 16, 2021Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Cardiovascular Outcomes

Interventions

Not provided

Countries

China

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2019Actual

Primary Completion Date

Jan 16, 2020Actual

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 14, 2019Actual

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

Sep 14, 2021

Last Update Posted Date

Sep 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in young healthy adults.

Detailed Description

To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in a panel study involving young healthy adults living in Beijing, China with extreme high ambient air pollution levels.

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

160Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	Systolic blood pressure and diastolic blood pressure	Four months

Secondary Outcomes

Measure	Description	Time Frame
Systemic inflammatory	Systemic inflammation biomarkers, such as C-reactive protein etc.	Four months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Living in Peking University Health Science Center neighborhood.
Non smoker and no diseases.

Exclusion Criteria:

Advanced microvascular complications and active cardiovascular disease.
Pregnancy or intent to get pregnant during the study period.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

non-smoker young healthy adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University ,School of Public Health		Beijing	Beijing Municipality	100191	China