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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

NCT ID: NCT01978405

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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

Keywords

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Type 2 diabetes Nephropathy Contrast medium Alpha lipoic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Alpha lipoic acid

Intervention Type DRUG

Placebo intervention group

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

Group Type PLACEBO_COMPARATOR

Alpha lipoic acid

Intervention Type DRUG

Interventions

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Alpha lipoic acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiang Guang-da

OTHER

Sponsor Role lead

Responsible Party

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Xiang Guang-da

Director of Endocrinol Dept.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiang Guangda, MD

Role: STUDY_DIRECTOR

Wuhan General Hospital

Locations

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Wuhan General Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang Guangda, MD

Role: CONTACT

Phone: +8602768878410

Email: [email protected]

Facility Contacts

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Xiang Guangda, MD

Role: primary

Other Identifiers

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2013Wze088

Identifier Type: -

Identifier Source: org_study_id