- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00745914
Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients
January 7, 2017 updated by: Dr. Angela Yee-Moon Wang, The University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
22
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 Locations
-
-
-
Hong Kong, Hong Kong, 0000
- Queen Mary Hospital and Tung Wah Hospital
-
Hong Kong, Hong Kong, 0000
- Queen Mary Hospital, Tung Wah Hospital
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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 Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Pioglitazone drug 15mg daily for 3 months then 30mg for 9 months (Peroxisome Proliferator-Activated Receptor-gamma agonist)
|
oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks
Other Names:
|
Placebo Comparator: 2
placebo comparator drug 15mg daily for 3months, then 30mg for 9 months
|
Placebo comparator
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in carotid plaque volume
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angela YM Wang, MD, FRCP, Queen Mary Hospital, University of Hong Kong
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
September 1, 2008
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
September 1, 2008
First Submitted That Met QC Criteria
September 2, 2008
First Posted (Estimate)
September 3, 2008
Study Record Updates
Last Update Posted (Estimate)
January 10, 2017
Last Update Submitted That Met QC Criteria
January 7, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A111-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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