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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598013
First Posted: January 18, 2008
Last Update Posted: January 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
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 Atherosclerosis Drug: Pioglitazone

Study Type: Interventional
Study Design: 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

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 ]

Secondary Outcome Measures:
  • carotid intima-media thickness [ Time Frame: 1 year ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598013


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyun Chul Lee, Professor, Department of internal medicine, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT00598013     History of Changes
Other Study ID Numbers: 4-2004-0082
82-2-2228-1930
First Submitted: January 9, 2008
First Posted: January 18, 2008
Last Update Posted: January 18, 2008
Last Verified: January 2008

Keywords provided by Yonsei University:
Kidney Transplantation
Thiazolidinediones
Insulin Resistance
Atherosclerosis

Additional relevant MeSH terms:
Insulin Resistance
Atherosclerosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Insulin, Globin Zinc
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs