Vascular Inflammation Stratified by Body Size Phenotype | NCT01979068

Studies
Vascular Inflammation Stratified by Body Size Phenotype

NCT01979068

Sponsor

Korea University

Status

Completed

Last Update Posted

Nov 8, 2013Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

Atherosclerosis
Obesity
Metabolic Syndrome

Interventions

Not provided

Countries

South Korea

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

Nov 2013

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

Mar 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Not provided

First Submitted Date

Oct 28, 2013

First Submission Date that Met QC Criteria

Nov 3, 2013

First Posted Date

Nov 8, 2013Estimated

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

Nov 3, 2013

Last Update Posted Date

Nov 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Vascular Inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying vascular inflammation within atherosclerotic plaque
Recently, unique subsets of obese individuals, such as metabolically obese but normal weight (MONW) and metabolically healthy obese (MHO), have been getting an attention
Therefore, the purpose of this study is to examine the relationship of vascular inflammation,measured by FDG-PET, with various body sized phenotypes

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
max TBR values stratified by the four body size phenotypes		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Framingham risk scores according to the four body size phenotypes		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
history of inflammatory conditions that affect the study results
taking medications that might affect inflammatory status, including steroid and non-steroidal anti-inflammatory drug within 6 months
or malignancy or severe renal or hepatic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers who underwent a medical health check in the health promotion center in Korea University Guro Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25529544	Derived	Yoo HJ, Kim S, Hwang SY, Hong HC, Choi HY, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Vascular inflammation in metabolically abnormal but normal-weight and metabolically healthy obese individuals analyzed with (1)(8)F-fluorodeoxyglucose positron emission tomography. Am J Cardiol. 2015 Feb 15;115(4):523-8. doi: 10.1016/j.amjcard.2014.11.036. Epub 2014 Nov 29.

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D050197	Atherosclerosis
D009765	Obesity
D024821	Metabolic Syndrome