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

Phase 4

• Conditions: Acute Kidney Injury; The Changes of Plasma Creatinine; The Changes of Plasma Free Radicals; The Changes of Endothelium-dependent Arterial Dilation
• Interventions: Drug: Alpha lipoic acid

• Registration Number: NCT01978405
• Lead Sponsor: Xiang Guang-da

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-10
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-31
• Study Start: 2013-11
• Last Update Submitted: 2013-11-06
• Study First Posted: 2013-11-07
• Last Update Posted: 2013-11-08
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo intervention group	Alpha lipoic acid	Only 0.9% sodium chloride 250 ml was given for this group.
alpha-lipoic acid group	Alpha lipoic acid	Alpha lipoic acid 600 mg in 0.9% sodium chloride 250 ml was given before and after contrast agent was administrated.

Primary Outcome Measures

Name	Time	Method
The changes of endothelium-dependent arterial dilation before and after contrast administrated	6 months
Contrast induced acte kidney injury	6 months

Trial Locations

Locations (1)

Wuhan General Hospital; 🇨🇳 Wuhan, Hubei, China