Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Disease Kidney Diseases Cardiovascular Diseases |
Drug: rosiglitazone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients? |
- carotid athersclerosis [ Time Frame: 6 month, 1 year and 2 year ]
- endothelial function [ Time Frame: 6 month, 1 year and 2 year ]
- all-cause mortality and cardiovascular event [ Time Frame: 1 year, 2 year ]
- pulse wave velocity [ Time Frame: 6 month, 1 year, 2 year ]
- inflammation [ Time Frame: 6 month, 1 year, 2 year ]
| Estimated Enrollment: | 160 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | November 2008 |
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
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
Contacts and Locations| Contact: Angela Wang, Dr | (852) 2855 4949 | aw2000_hk@yahoo.com |
| China | |
| Department of Medicine, Queen Mary Hospital | Recruiting |
| Hong Kong, China | |
| Sub-Investigator: KN Lai, Prof | |
| Department of Medicine, Tung Wah Hospital | Recruiting |
| Hong Kong, China | |
| Sub-Investigator: WK Lo, Dr | |
| Principal Investigator: | Angela Wang, Dr | Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00516880 History of Changes |
| Other Study ID Numbers: | UW05-236T/899, HARECCTR0500007 |
| Study First Received: | August 15, 2007 |
| Last Updated: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
chronic kidney disease cardiovascular disease |
Additional relevant MeSH terms:
|
Atherosclerosis Calcinosis Cardiovascular Diseases Chronic Disease Inflammation Kidney Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Calcium Metabolism Disorders Metabolic Diseases Disease Attributes Pathologic Processes Urologic Diseases Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013