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NCT01556984 Clinical Trial

Changes of Endothelial Function Before and After DSA in Patients With Diabetes

Diabetes Clinical Trial

Official title:
Changes of Endothelial Function Before and After DSA in Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01556984
Other study ID # wz2010007
Secondary ID
Status Completed
Phase N/A
First received March 15, 2012
Last updated June 12, 2015
Start date October 2012
Est. completion date October 2013

Study information
Verified date June 2015
Source Wuhan General Hospital of Guangzhou Military Command
Contact n/a
Is FDA regulated No
Health authority Ethics Committee:China
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date October 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with diabetic foot

- Age 40 to 70 years old

Exclusion Criteria:

- Heart failure

- Renal failure

- Acute infection

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• DSA assay
All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.

Locations
Country Name City State
China Wuhan General Hospital Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Wuhan General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The changes of endothelial function 10 months Yes
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