The Effect of Contrast Agent on Endothelial Function in Healthy Men

• Sponsor: Xiang Guang-da (Other)
• Overall Status: Completed
• CT.gov ID: NCT01895699
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Agent; Endothelial Function; Cytokines; Apoptosis of Endothelial Progenitor Cell; Free Radical; Alpha-lipoic Acid	Other: Contrast agent	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: The Effect of Contrast Agent on Endothelial Function in Healthy Men
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: contrast group (Ioversol) Each individual will be given 80 ml Ioversol via intravenous injection within 5 minutes	Other: Contrast agent
Placebo Comparator: Placebo group
Other: 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.	Other: Contrast agent

Outcome Measures

Primary Outcome Measures

1. The endothelial dysfunction and the protective role of alpha-lipoic acid [6 months]

Secondary Outcome Measures

1. The apoptosis of endothelial progenitor cell [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wuhan General Hospital	Wuhan	Hubei	China	430070

Sponsors and Collaborators

• Xiang Guang-da

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiang Guang-da, Director of Endocrinol and Metab, Wuhan General Hospital of Guangzhou Military Command
• ClinicalTrials.gov Identifier: NCT01895699
• Other Study ID Numbers: 2013Wze033
• First Posted: Jul 10, 2013
• Last Update Posted: Aug 13, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Xiang Guang-da, Director of Endocrinol and Metab, Wuhan General Hospital of Guangzhou Military Command: Contrast agent; endothelium; Free radical; Alpha lipoic acid

Study Results

No Results Posted as of Aug 13, 2015