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

Xiang Guang-da

Status and phase: Unknown; Phase 4

Conditions: The Changes of Plasma Creatinine; The Changes of Plasma Free Radicals; Acute Kidney Injury; The Changes of Endothelium-dependent Arterial Dilation

Treatments: Drug: Alpha lipoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01978405

2013Wze088

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

alpha-lipoic acid group

Experimental group

Description:

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

Treatment:

Drug: Alpha lipoic acid

Placebo intervention group

Placebo Comparator group

Description:

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

Treatment:

Drug: Alpha lipoic acid