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

Primary Purpose

Acute Kidney Injury, The Changes of Plasma Creatinine, The Changes of Plasma Free Radicals

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Alpha lipoic acid

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Type 2 diabetes, Nephropathy, Contrast medium, Alpha lipoic acid

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Wuhan General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alpha-lipoic acid group

Placebo intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Contrast induced acte kidney injury

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01978405

First Posted

October 25, 2013

Last Updated

November 6, 2013

Sponsor

Xiang Guang-da

1. Study Identification

Unique Protocol Identification Number

NCT01978405

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiang Guang-da

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury, The Changes of Plasma Creatinine, The Changes of Plasma Free Radicals, The Changes of Endothelium-dependent Arterial Dilation

Keywords

Type 2 diabetes, Nephropathy, Contrast medium, Alpha lipoic acid

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

alpha-lipoic acid group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo intervention group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Alpha lipoic acid

Primary Outcome Measure Information:

Title

Contrast induced acte kidney injury

Time Frame

6 months

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiang Guangda, MD

Phone

+8602768878410

Guangda64@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiang Guangda, MD

Organizational Affiliation

Wuhan General Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Wuhan General Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430070

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiang Guangda, MD

Phone

+8602768878410

12. IPD Sharing Statement

Learn more about this trial

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

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