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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01978405
• Other study ID #: 2013Wze088
• Status: Recruiting
• Phase: Phase 4
• First received: October 25, 2013
• Last updated: November 6, 2013
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2013
• Source: Wuhan General Hospital of Guangzhou Military Command
• Contact: Xiang Guangda, MD
• Phone: +8602768878410
• Email: Guangda64[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Diabetes Mellitus, Type 2
• The Changes of Endothelium-dependent Arterial Dilation
• The Changes of Plasma Creatinine
• The Changes of Plasma Free Radicals

Intervention

Drug:
• Alpha lipoic acid

Locations

Country	Name	City	State
China	Wuhan General Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiang Guang-da

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced acte kidney injury		6 months	Yes
Primary	The changes of endothelium-dependent arterial dilation before and after contrast administrated		6 months	Yes