The Effect of Contrast Agent on Endothelial Function in Healthy Men

Xiang Guang-da

Status and phase: Completed; Phase 4

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

Treatments: Other: Contrast agent

Study type: Interventional

Funder types: Other

Identifiers

NCT01895699

2013Wze033

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

contrast group (Ioversol)

Experimental group

Description:

Each individual will be given 80 ml Ioversol via intravenous injection within 5 minutes

Treatment:

Other: Contrast agent

Placebo group

Placebo Comparator group

alpha-lipoic acid group

Other group

Description:

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.

Treatment:

Other: Contrast agent