Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?

July 6, 2010 updated by: Hospital Authority, Hong Kong
Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. Our recent data showed that inflammation predicts mortality and cardiovascular death, independent of other cardiovascular risk factors in peritoneal dialysis patients. As a considerable proportion of peritoneal dialysis patients showed evidence of inflammation, it raises an important question as to whether anti-inflammatory treatment has any cardiovascular and survival benefit in these patients. The peroxisome proliferator-activated receptor-gamma (PPAR-g) agonist is a class of drug with insulin sensitizing property. Recent experimental and clinical studies demonstrated that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than insulin sensitizing effect in type 2 diabetics. We therefore hypothesize that modulation of the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and retarding the progression of atherosclerosis and possibly lowering mortality in our peritoneal dialysis patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Department of Medicine, Queen Mary Hospital
        • Sub-Investigator:
          • KN Lai, Prof
      • Hong Kong, China
        • Recruiting
        • Department of Medicine, Tung Wah Hospital
        • Sub-Investigator:
          • WK Lo, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both prevalent patients or patients newly started on continuous ambulatory peritoneal dialysis with age between 20 - 75 with or without diabetes mellitus will be considered eligible for study entry. For patients newly started on continuous ambulatory peritoneal dialysis, they will be suitable for recruitment into the study after one month on continuous ambulatory peritoneal dialysis.

Exclusion Criteria:

  • Patients with underlying malignancy
  • Patients with chronic liver disease or liver cirrhosis
  • Patients with hepatitis B or C positive
  • Patients with active infections
  • Patients with other chronic active inflammatory disease such as systemic lupus erythematosus, rheumatoid arthritis
  • Patients who refuse study participation
  • Patients with underlying congenital heart disease or rheumatic heart disease
  • Patients with poor general condition
  • Patients with plans for living related kidney transplant within 2 years
  • Female patients with pregnancy
  • Patients with history of recurrent hypoglycemia
  • Patients with Class III and IV congestive heart failure
  • Patients already receiving glitazones treatment at the screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
carotid athersclerosis
Time Frame: 6 month, 1 year and 2 year
6 month, 1 year and 2 year
endothelial function
Time Frame: 6 month, 1 year and 2 year
6 month, 1 year and 2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality and cardiovascular event
Time Frame: 1 year, 2 year
1 year, 2 year
pulse wave velocity
Time Frame: 6 month, 1 year, 2 year
6 month, 1 year, 2 year
inflammation
Time Frame: 6 month, 1 year, 2 year
6 month, 1 year, 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Angela Wang, Dr, Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ANTICIPATED)

November 1, 2008

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (ESTIMATE)

August 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW05-236T/899
  • HARECCTR0500007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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