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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745914
• Other study ID #: A111-103
• Status: Completed
• Phase: N/A
• First received: September 1, 2008
• Last updated: January 7, 2017
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Endstage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Pioglitazone
oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks
• Placebo comparator
Placebo comparator

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital and Tung Wah Hospital	Hong Kong
Hong Kong	Queen Mary Hospital, Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in carotid plaque volume		12 months	No
Secondary	Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases		12 months	No