Effect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes
Information source: Yonsei University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation; Insulin Resistance; Atherosclerosis
Intervention: Pioglitazone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Yonsei University Official(s) and/or principal investigator(s):
Hyun Chul Lee, Doctor, Principal Investigator, Affiliation: Yonsei University College of Medicine
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.
Clinical Details
Official title: A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes
Study design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Insulin Resistance and Insulin Secretion
Secondary outcome: carotid intima-media thickness
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Yonsei University College of Medicine, Seoul 120-752, Korea, Republic of
Additional Information
Starting date: November 2004
Ending date: November 2007
Last updated: January 17, 2008
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