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Completed

NCT Number: NCT00598013

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

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.

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Key information

Conditions

Kidney Transplantation Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University College of Medicine

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

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

Primary outcomes

  1. Insulin Resistance and Insulin Secretion

    Time frame: 1 year

Secondary outcomes

  1. carotid intima-media thickness

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 18, 2008
Registry last updated
Jan 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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