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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01556984
First received: March 15, 2012
Last updated: June 12, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention
Diabetes
Other: DSA assay

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Changes of Endothelial Function Before and After DSA in Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by Wuhan General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • The changes of endothelial function [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DSA group Other: DSA assay
All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.
control group

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Patients with diabetic foot
  • Age 40 to 70 years old

Exclusion Criteria:

  • Heart failure
  • Renal failure
  • Acute infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556984

Locations
China, Hubei
Wuhan General Hospital
Wuhan, Hubei, China, 430070
Sponsors and Collaborators
Wuhan General Hospital of Guangzhou Military Command
  More Information

Responsible Party: Xiang Guang-da, Director of Wuhan General Hospital, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01556984     History of Changes
Other Study ID Numbers: wz2010007 
Study First Received: March 15, 2012
Last Updated: June 12, 2015
Health Authority: Ethics Committee:China

Keywords provided by Wuhan General Hospital of Guangzhou Military Command:
diabetic foot
digital subtraction angiography
endothelial function
Patients with diabetes
Age 40 to 70 years old
Endothelial function are determined

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2016