The Effect of Contrast Agent on Endothelial Function in Healthy Men

NCT ID: NCT01895699

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

contrast group (Ioversol)

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

Group Type: EXPERIMENTAL

Contrast agent

Intervention Type: OTHER

Placebo group

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

alpha-lipoic acid group

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.

Group Type: OTHER

Contrast agent

Intervention Type: OTHER

Interventions

Contrast agent

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xiang Guang-da

OTHER

Sponsor Role: lead

Responsible Party

Xiang Guang-da

Director of Endocrinol and Metab

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wuhan General Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

2013Wze033

Identifier Type: -

Identifier Source: org_study_id