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OpenTrials
Completed

NCT Number: NCT00745914

Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients

To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.

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Key information

Conditions

Endstage Renal Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital and Tung Wah Hospital, Hong Kong

Loading trial locations.

About this study

End-stage renal disease (ESRD) patients are at an increased risk of accelerated atherosclerosis and cardiovascular morbidity and mortality. Non-traditional risk factors such as inflammation and insulin resistance have important contributions to accelerated atherosclerosis in ESRD patients receiving long-term peritoneal dialysis (PD). The peroxisome proliferator-activated receptor-g (PPAR-g) is a member of the nuclear receptor family of ligand-dependent transcription factors. Activation of the PPAR-g has been shown in both clinical and experimental studies to have anti-inflammatory and anti-atherosclerotic properties other than insulin-sensitizing effects. Recent study also showed that PPAR-g agonists reduce plaque inflammation by inhibiting the activation of proinflammatory genes responsible for plaque development and growth. Hence, this study aims to examine the effects of PPAR-g activation on the progression of carotid plaque in diabetic ESRD patients receiving long-term PD using high-resolution magnetic resonance imaging (MRI).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetic ESRD patients receiving long-term PD treatment, with carotid plaque (defined as focal intima-media thickening >1mm) present on screening ultrasonography
  • Patients who provide informed consent for the study

Exclusion criteria

  • Patients with systemic inflammatory disease such as systemic lupus erythematosus
  • Patients with chronic liver disease or cirrhosis
  • Patients with current active malignancy
  • Patients with chronic rheumatic heart disease or congenital heart disease
  • Patients with poor general condition
  • Patients with plan for living related kidney transplant within coming 1 year
  • Patients with pre-existing class III/IV heart failure,
  • Patients with recurrent hypoglycemia
  • Patients already on glitazone treatment
  • Female patients with pregnancy
  • Patients with contraindications for MRI examination including those with pacemaker or metallic implant.

Treatment and study plan

pioglitazone

Drug

oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks

Other names: Actos

placebo comparator

Drug

Placebo comparator

Other names: Placebo

Primary outcomes

  1. Change in carotid plaque volume

    Time frame: 12 months

Secondary outcomes

  1. Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Randomized Placebo-Controlled Study to Evaluate the Efficacy of Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Inducing Carotid Atherosclerotic Plaque Regression in Diabetic End-Stage Renal Disease Patients

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 3, 2008
Registry last updated
Jan 10, 2017

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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