Effect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes
A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes
2 other identifiers
interventional
83
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 9, 2008
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedJanuary 18, 2008
January 1, 2008
3 years
January 9, 2008
January 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin Resistance and Insulin Secretion
1 year
Secondary Outcomes (1)
carotid intima-media thickness
1 year
Study Arms (2)
1
EXPERIMENTAL2
NO INTERVENTIONInterventions
The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (2)
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.
PMID: 32803882DERIVEDHan 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.
PMID: 19875376DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun Chul Lee, Doctor
Yonsei University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 9, 2008
First Posted
January 18, 2008
Study Start
November 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
January 18, 2008
Record last verified: 2008-01