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

Sponsor

Xiang Guang-da (Other)

Overall Status

Unknown status

CT.gov ID

NCT01978405

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury The Changes of Plasma Creatinine The Changes of Plasma Free Radicals The Changes of Endothelium-dependent Arterial Dilation	Drug: Alpha lipoic acid	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Alpha lipoic acid
Placebo Comparator: Placebo intervention group Only 0.9% sodium chloride 250 ml was given for this group.	Drug: Alpha lipoic acid

Arm

Intervention/Treatment

Experimental: 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.

Drug: Alpha lipoic acid

Placebo Comparator: Placebo intervention group

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

Drug: Alpha lipoic acid

Outcome Measures

Primary Outcome Measures

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