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Clinical Trials/NCT01978405
NCT01978405
Unknown
Phase 4

Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes

Xiang Guang-da1 site in 1 country200 target enrollmentNovember 2013

Overview

Phase
Phase 4
Intervention
Alpha lipoic acid
Conditions
Acute Kidney Injury
Sponsor
Xiang Guang-da
Enrollment
200
Locations
1
Primary Endpoint
The changes of endothelium-dependent arterial dilation before and after contrast administrated
Last Updated
12 years ago

Overview

Brief Summary

Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and endothelial dysfunction in type 2 diabetes.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
June 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xiang Guang-da
Responsible Party
Sponsor Investigator
Principal Investigator

Xiang Guang-da

Director of Endocrinol Dept.

Wuhan General Hospital of Guangzhou Military Command

Eligibility Criteria

Inclusion Criteria

  • type 2 diabetes
  • nephropathy (stage 3 and 4)

Exclusion Criteria

  • recive alpha lipoic acid
  • type 1 diabetes
  • nephropathy (stagte 1, 2 and 5)
  • hypersensitivity to contrast media
  • IV heart failure
  • lactic acidosis

Arms & Interventions

Placebo intervention group

Only 0.9% sodium chloride 250 ml was given for this group.

Intervention: Alpha lipoic acid

alpha-lipoic acid group

Alpha lipoic acid 600 mg in 0.9% sodium chloride 250 ml was given before and after contrast agent was administrated.

Intervention: Alpha lipoic acid

Outcomes

Primary Outcomes

The changes of endothelium-dependent arterial dilation before and after contrast administrated

Time Frame: 6 months

Contrast induced acte kidney injury

Time Frame: 6 months

Study Sites (1)

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