NCT01099865

Brief Summary

The UKPDS risk score is recommended to assess global risk for future coronary heart disease (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising imaging technique for the evaluation of vascular inflammation that reflects vulnerable atherosclerotic plaque.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Shorter than P25 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

December 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
Last Updated

April 8, 2010

Status Verified

April 1, 2010

Enrollment Period

4 months

First QC Date

April 7, 2010

Last Update Submit

April 7, 2010

Conditions

AtherosclerosisType 2 Diabetes

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

type 2 diabetes

You may qualify if:

  • Type 2 diabetes

You may not qualify if:

  • Myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization
  • Resting blood pressure ≥160/100 mmHg
  • Malignancy, or severe renal or hepatic disease
  • Participants were free of any lipid-lowering therapies and postmenopausal hormone replacement therapy at least the 6 month period prior to enrollment
  • History of inflammatory condition or those taking medications that might affect inflammatory status within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital Dept. of Endocrinology

Seoul, South Korea

Location

MeSH Terms

Conditions

AtherosclerosisDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 8, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 8, 2010

Record last verified: 2010-04

Locations

KR(1)