Effect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes

NCT ID: NCT00598013

Last Updated: 2008-01-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-11-30

Brief Summary

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The aim of this study was to evaluate the effect of pioglitazone treatment on insulin secretion, insulin resistance, and progression of atherosclerosis in renal allograft recipients without preoperative history of diabetes.

Detailed Description

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This is a prospective, randomized, open-label study. The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.

After treatment, we estimated insulin sensitivity index for transplantation,first phase and second phase insulin secretion, secretion area under the curve,and carotid intima-media thickness.

Conditions

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Kidney Transplantation Insulin Resistance Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pioglitazone

Intervention Type DRUG

The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pioglitazone

The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Renal allograft recipients were eligible to participate in the study if they were aged ≥ 18 years, had no previous history of organ transplantation and were not currently using steroids or other immunosuppressants.

Exclusion Criteria

* Diabetes before transplantation
* Severe metabolic or infectious disease
* Hepatic disease
* Congestive heart failure (New York Heart Association II-IV)
* Cadaver donor kidney donor transplantation
* Unstable condition of the transplanted kidney
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Department of internal medicine, Yonsei University College of Medicine

Principal Investigators

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Hyun Chul Lee, Doctor

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

Reference Type DERIVED
PMID: 32803882 (View on PubMed)

Han SJ, Hur KY, Kim YS, Kang ES, Kim SI, Kim MS, Kwak JY, Kim DJ, Choi SH, Cha BS, Lee HC. Effects of pioglitazone on subclinical atherosclerosis and insulin resistance in nondiabetic renal allograft recipients. Nephrol Dial Transplant. 2010 Mar;25(3):976-84. doi: 10.1093/ndt/gfp567. Epub 2009 Oct 28.

Reference Type DERIVED
PMID: 19875376 (View on PubMed)

Other Identifiers

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82-2-2228-1930

Identifier Type: -

Identifier Source: secondary_id

4-2004-0082

Identifier Type: -

Identifier Source: org_study_id

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