The Effect of Contrast Agent on Endothelial Function in Healthy Men

Phase 4

Completed

• Conditions: Apoptosis of Endothelial Progenitor Cell; Contrast Agent; Endothelial Function; Cytokines; Free Radical; Alpha-lipoic Acid
• Interventions: Other: Contrast agent

• Registration Number: NCT01895699
• Lead Sponsor: Xiang Guang-da

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
contrast group (Ioversol)	Contrast agent	Each individual will be given 80 ml Ioversol via intravenous injection within 5 minutes
alpha-lipoic acid group	Contrast agent	Alpha-lipoic acid 600 mg in 0.9% sodium chloride 250 ml was administrated 1 hour before contrast agents via venous. and only 0.9% sodium chloride 250 ml was administrated for other 2 groups.

Primary Outcome Measures

Name	Time	Method
The endothelial dysfunction and the protective role of alpha-lipoic acid	6 months

Secondary Outcome Measures

Name	Time	Method
The apoptosis of endothelial progenitor cell	6 months

Trial Locations

Locations (1)

Wuhan General Hospital; 🇨🇳 Wuhan, Hubei, China