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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT00598013

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Insulin Resistance Atherosclerosis	Drug: Pioglitazone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Pioglitazone The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.
No Intervention: 2

Arm

Intervention/Treatment

Experimental: 1

Drug: Pioglitazone

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

No Intervention: 2

Outcome Measures

Primary Outcome Measures

Insulin Resistance and Insulin Secretion [1 year]

Secondary Outcome Measures

carotid intima-media thickness [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.