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

Not Applicable

Completed

• Conditions: Endstage Renal Disease; Diabetes
• Interventions: Drug: Placebo comparator; Drug: Pioglitazone

• Registration Number: NCT00745914
• Lead Sponsor: The University of Hong Kong

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).

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-01
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-07
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo comparator	placebo comparator drug 15mg daily for 3months, then 30mg for 9 months
1	Pioglitazone	Pioglitazone drug 15mg daily for 3 months then 30mg for 9 months (Peroxisome Proliferator-Activated Receptor-gamma agonist)

Primary Outcome Measures

Name	Time	Method
Change in carotid plaque volume	12 months

Secondary Outcome Measures

Name	Time	Method
Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases	12 months

Trial Locations

Locations (2)

Queen Mary Hospital and Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital, Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong