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CompletedNCT01895699Updated Aug 13, 2015

The Effect of Contrast Agent on Endothelial Function in Healthy Men

A Phase 4 interventional study of Contrast agent in Contrast Agent, Endothelial Function and Cytokines, sponsored by Xiang Guang-da. Completed at 1 site in China. Open to male participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Xiang Guang-da · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 30 Years
Sex
Male
01

Study 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.

02

Conditions studied

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

Keywords

  • Contrast agent
  • endothelium
  • Free radical
  • Alpha lipoic acid
03

In context

Lead sponsor

Xiang Guang-da is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy men
  • 20 yr \< = age \< = 30 yr
  • 20 \< = body mass index \< = 25

Exclusion criteria

Exclusion Criteria:

  • age \< 20 yr or > 30 yr
  • dysfunction for liver, renal, and heart.
  • other diseases such as diabetes, hypertension, thyroid disease
05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • OtherContrast agent
06

What researchers measure

Primary outcomes

  1. The endothelial dysfunction and the protective role of alpha-lipoic acid

    Time frame: 6 months

Secondary outcomes

  1. The apoptosis of endothelial progenitor cell

    Time frame: 6 months

07

Study locations

1 site
  • Wuhan General Hospital
    Wuhan, Hubei 430070, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01895699
Lead sponsor
Xiang Guang-da
Responsible party
Xiang Guang-da (Director of Endocrinol and Metab, Wuhan General Hospital of Guangzhou Military Command) — Sponsor-investigator
First posted
Jul 10, 2013
Start date
Jul 2013
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Aug 13, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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