The Effect of Contrast Agent on Endothelial Function in Healthy Men

Endothelial Function Clinical Trial

Official title:

The Effect of Contrast Agent on Endothelial Function in Healthy Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895699
• Other study ID #: 2013Wze033
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2013
• Last updated: August 11, 2015
• Start date: July 2013
• Est. completion date: July 2015

Study information

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

Clinical Trial Summary

Contrast medium is essential for diagnosis of many diseases. However, recent studies showed that contrast agents can induce renal injury and is associated with poor long-term clinical outcome, especially in diabetes. To date, no data are available on the relationship between contrast medium and endothelial function. Endothelial dysfunction is known to precede atherosclerosis and is considered a risk marker for future development of cardiovascular disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial dysfunction induced by contrast agents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• healthy men

• 20 yr < = age < = 30 yr

• 20 < = body mass index < = 25

Exclusion Criteria:

• age < 20 yr or > 30 yr

• dysfunction for liver, renal, and heart.

• other diseases such as diabetes, hypertension, thyroid disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alpha-lipoic Acid
• Apoptosis of Endothelial Progenitor Cell
• Contrast Agent
• Cytokines
• Endothelial Function
• Free Radical

Intervention

Other:
• Contrast agent

Locations

Country	Name	City	State
China	Wuhan General Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiang Guang-da

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The endothelial dysfunction and the protective role of alpha-lipoic acid		6 months	Yes
Secondary	The apoptosis of endothelial progenitor cell		6 months	Yes