Changes of Endothelial Function Before and After DSA in Patients With Diabetes
June 12, 2015 updated by: Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
Endothelial dysfunction is the early step of atherosclerosis.
Therefore, the investigators hypothesize that digital subtraction angiography (DSA) can damage endothelial function.
In this study, the investigators will select 200 diabetic patients who have a DSA for diabetic foot screening.
Also, the investigators will select 100 healthy subjects as controls.
The endothelial function will be determined by high resolution ultrasound before and after DSA.
The investigators will observe the changes of endothelial function after DSA assay.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
200
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
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Hubei
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Wuhan, Hubei, China, 430070
- Wuhan General Hospital
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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
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
We will select 200 patients with diabetes.
DSA will be taken for this group.
Endothelial function will be measured before and after DSA.
In the meantime, 100 healthy subjects will be selected as controls.
Description
Inclusion Criteria:
- Patients with diabetic foot
- Age 40 to 70 years old
Exclusion Criteria:
- Heart failure
- Renal failure
- Acute infection
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
|
|
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DSA group
|
All patients with diabetic foot perform a DSA assay.
Before and after DSA, endothelial function will be measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The changes of endothelial function
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
October 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
March 15, 2012
First Submitted That Met QC Criteria
March 16, 2012
First Posted (Estimate)
March 19, 2012
Study Record Updates
Last Update Posted (Estimate)
June 16, 2015
Last Update Submitted That Met QC Criteria
June 12, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- wz2010007
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