NCT01895699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

July 4, 2013

Last Update Submit

August 11, 2015

Conditions

Contrast AgentEndothelial FunctionCytokinesApoptosis of Endothelial Progenitor CellFree RadicalAlpha-lipoic Acid

Keywords

Contrast agentendotheliumFree radicalAlpha lipoic acid

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • The apoptosis of endothelial progenitor cell

    6 months

Study Arms (3)

contrast group (Ioversol)

EXPERIMENTAL

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

Other: Contrast agent

Placebo group

PLACEBO COMPARATOR

alpha-lipoic acid group

OTHER

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

Contrast agentOTHER
alpha-lipoic acid groupcontrast group (Ioversol)

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Interventions

Contrast Media

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Endocrinol and Metab

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 10, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

CN(1)