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

This study has been completed.
Information provided by:
Yonsei University Identifier:
First received: January 9, 2008
Last updated: January 17, 2008
Last verified: January 2008

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 Intervention
Kidney Transplantation
Insulin Resistance
Drug: Pioglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Insulin Resistance and Insulin Secretion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • carotid intima-media thickness [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: November 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pioglitazone
The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.
No Intervention: 2

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00598013

Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Principal Investigator: Hyun Chul Lee, Doctor Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hyun Chul Lee, Professor, Department of internal medicine, Yonsei University College of Medicine Identifier: NCT00598013     History of Changes
Other Study ID Numbers: 4-2004-0082, 82-2-2228-1930
Study First Received: January 9, 2008
Last Updated: January 17, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Kidney Transplantation
Insulin Resistance

Additional relevant MeSH terms:
Insulin Resistance
Arterial Occlusive Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 20, 2014