NCT01979068

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

October 28, 2013

Last Update Submit

November 3, 2013

Conditions

AtherosclerosisObesityMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • max TBR values stratified by the four body size phenotypes

    12 weeks

Secondary Outcomes (1)

  • Framingham risk scores according to the four body size phenotypes

    12 weeks

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Healthy patients for visiting routine medical check in our clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25529544DERIVED

MeSH Terms

Conditions

AtherosclerosisObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 8, 2013

Study Start

March 1, 2008

Primary Completion

March 1, 2011

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

KR(1)