Changes of Endothelial Function Before and After DSA in P... | NCT01556984

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

NCT01556984

Sponsor

Wuhan General Hospital of Guangzhou Military Command

Status

Completed

Last Update Posted

Jun 16, 2015Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Diabetes

Interventions

DSA assay

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Mar 15, 2012

First Submission Date that Met QC Criteria

Mar 16, 2012

First Posted Date

Mar 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2015

Last Update Posted Date

Jun 16, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiang Guang-da, Director of Wuhan General Hospital, Wuhan General Hospital of Guangzhou Military CommandPrincipal Investigator

Lead Sponsor

Wuhan General Hospital of Guangzhou Military CommandOTHER

Collaborators

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DSA group			Other: DSA assay
control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DSA assay	Other	All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.	DSA group

Measure	Description	Time Frame
The changes of endothelial function		10 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with diabetic foot
Age 40 to 70 years old

Exclusion Criteria:

Heart failure
Renal failure
Acute infection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan General Hospital		Wuhan	Hubei	430070	China

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided