Vascular Inflammation Stratified by Body Size Phenotype

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979068
• Other study ID #: PET_MONW
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: November 3, 2013
• Start date: March 2008

Study information

• Verified date: November 2013
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	max TBR values stratified by the four body size phenotypes		12 weeks	No
Secondary	Framingham risk scores according to the four body size phenotypes		12 weeks	No