NCT01978405

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 8, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

October 25, 2013

Last Update Submit

November 6, 2013

Conditions

Acute Kidney InjuryThe Changes of Plasma CreatinineThe Changes of Plasma Free RadicalsThe Changes of Endothelium-dependent Arterial Dilation

Keywords

Type 2 diabetesNephropathyContrast mediumAlpha lipoic acid

Outcome Measures

Primary Outcomes (2)

  • Contrast induced acte kidney injury

    6 months

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

    6 months

Study Arms (2)

alpha-lipoic acid group

EXPERIMENTAL

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 intervention group

PLACEBO COMPARATOR

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

Drug: Alpha lipoic acid

Interventions

Alpha lipoic acidDRUG
Placebo intervention groupalpha-lipoic acid group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • nephropathy (stage 3 and 4)

You may not qualify if:

  • recive alpha lipoic acid
  • type 1 diabetes
  • nephropathy (stagte 1, 2 and 5)
  • hypersensitivity to contrast media
  • IV heart failure
  • lactic acidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan General Hospital

Wuhan, Hubei, 430070, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney InjuryDiabetes Mellitus, Type 2Kidney Diseases

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Xiang Guangda, MD

    Wuhan General Hospital

    STUDY DIRECTOR

Central Study Contacts

Xiang Guangda, MD

CONTACT

+8602768878410Guangda64@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Endocrinol Dept.

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 7, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 8, 2013

Record last verified: 2013-10

Locations

CN(1)