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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


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
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