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

Insulin Resistance Clinical Trial

Official title:

A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598013
• Other study ID #: 4-2004-0082
• Secondary ID: 82-2-2228-1930
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: January 17, 2008
• Start date: November 2004
• Est. completion date: November 2007

Study information

• Verified date: January 2008
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Insulin Resistance
• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Resistance and Insulin Secretion		1 year	No
Secondary	carotid intima-media thickness		1 year	No