DiabetesNCT01556984
Changes of Endothelial Function Before and After DSA in Patients With Diabetes
An observational study of Diabetes, run by Wuhan General Hospital of Guangzhou Military Command at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- DSA assay
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Patients with diabetic foot
- Age 40 to 70 years old
Who cannot join
- Heart failure
- Renal failure
- Acute infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes
- Being tested
- DSA assay
- Keywords
- diabetic foot, digital subtraction angiography, endothelial function, Patients with diabetes, Age 40 to 70 years old, Endothelial function are determined
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSA assayOther
All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.
| Study group | Role | What they receive |
|---|---|---|
| DSA group | Not described Receives: Other: DSA assay | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of endothelial function
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556984
- Sponsor's protocol ID
- wz2010007
- Status last verified
- Jun 2015
- First submitted
- 15 Mar 2012
- Last updated
- 16 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Endothelial Function Before and After DSA in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01556984
- Acronym / sponsor ID
- wz2010007
- Conditions
- Diabetes
- Keywords
- diabetic foot, digital subtraction angiography, endothelial function, Patients with diabetes, Age 40 to 70 years old, Endothelial function are determined
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wuhan General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSA group | – | Other: DSA assay |
| control group | – | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Patients with diabetic foot
- Age 40 to 70 years old
Key exclusion criteria (3 listed)
- Heart failure
- Renal failure
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSA assayAll patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured. | Other | DSA group |
Primary outcome
The changes of endothelial function
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Wuhan General Hospital of Guangzhou Military Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of endothelial function (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.