Clinical trial NCT00745914: Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endstage Renal Disease
Diabetes
Keywords: PPAR-gamma, diabetic, kidney disease, atherosclerosis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in carotid plaque volume
timeFrame: 12 months
Secondary outcomes:
measure: Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital and Tung Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Tung Wah Hospital
Study officials:
affiliation: Queen Mary Hospital, University of Hong Kong
name: Angela YM Wang, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: