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

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ClinicalTrials.gov Identifier: NCT00745914
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : January 10, 2017
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong

September 1, 2008
September 3, 2008
January 10, 2017
September 2008
September 2013   (Final data collection date for primary outcome measure)
Change in carotid plaque volume [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00745914 on ClinicalTrials.gov Archive Site
Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients
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
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.
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).
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Endstage Renal Disease
  • Diabetes
  • Drug: Pioglitazone
    oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks
    Other Name: Actos
  • Drug: Placebo comparator
    Placebo comparator
    Other Name: Placebo
  • Experimental: 1
    Pioglitazone drug 15mg daily for 3 months then 30mg for 9 months (Peroxisome Proliferator-Activated Receptor-gamma agonist)
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: 2
    placebo comparator drug 15mg daily for 3months, then 30mg for 9 months
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2013
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Hong Kong
Not Provided
Plan to Share IPD: No
Dr. Angela Yee-Moon Wang, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Angela YM Wang, MD, FRCP Queen Mary Hospital, University of Hong Kong
The University of Hong Kong
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP