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

Not Applicable

Completed

• Conditions: Kidney Transplantation; Insulin Resistance; Atherosclerosis
• Interventions: Drug: Pioglitazone

• Registration Number: NCT00598013
• Lead Sponsor: Yonsei University

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.

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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2008-01
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-17
• Last Update Submitted: 2008-01-17
• Study First Posted: 2008-01-18
• Last Update Posted: 2008-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pioglitazone	-

Primary Outcome Measures

Name	Time	Method
Insulin Resistance and Insulin Secretion	1 year

Secondary Outcome Measures

Name	Time	Method
carotid intima-media thickness	1 year

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of