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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wang Angela Yee-Moon, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00745914
First received: September 1, 2008
Last updated: June 11, 2013
Last verified: June 2013

September 1, 2008
June 11, 2013
September 2008
September 2013   (final data collection date for primary outcome measure)
Change in carotid plaque volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
  • Experimental: 1
    Pioglitazone drug (Peroxisome Proliferator-Activated Receptor-gamma agonist)
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: 2
    placebo comparator drug
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00745914
A111-103
Yes
Wang Angela Yee-Moon, 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
June 2013

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