- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979068
Vascular Inflammation Stratified by Body Size Phenotype
November 3, 2013 updated by: K. M. Choi, Korea University
- 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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Korea University Guro Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers who underwent a medical health check in the health promotion center in Korea University Guro Hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
max TBR values stratified by the four body size phenotypes
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Framingham risk scores according to the four body size phenotypes
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
October 28, 2013
First Submitted That Met QC Criteria
November 3, 2013
First Posted (Estimate)
November 8, 2013
Study Record Updates
Last Update Posted (Estimate)
November 8, 2013
Last Update Submitted That Met QC Criteria
November 3, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PET_MONW
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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