Pioglitazone Attenuates Dysmetabolism in Peritoneal Dialysis (PD) Patients

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Background:Cardiovascular disease (CVD) is the major cause of mortality in peritoneal dialysis (PD) patients, in whom it is partly attributable to a higher prevalence of dysmetabolism. Currently, few treatments are available with a proven effect on dyslipidemia, insulin resistance and inflammation in this patient group.

2. Study design: Randomized, cross-over trial.

3. Settings and Participants: Prevalent PD patients (>20 years old, s-triglycerides >1.8 mmol/L) who had never received glitazones were enrolled.

4. Interventions: Participants were randomized to receive either oral pioglitazone (PIO; 15 mg once daily) and no pioglitazone, both for 12 weeks and in random order, with a four-week wash out in between.

5. Outcomes and measurements: The primary endpoint was change of serum triglyceride (TG) level during the PIO as compared to no PIO. Secondary endpoints included changes in other lipid levels, HOMA-IR, adipocytokines and CRP. Outcome effects were assessed using a GLM.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Collaborator: Baxter Healthcare Corporation
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

All patients received more than one month regular continuous ambulatory peritoneal dialysis(CAPD) or intermittent peritoneal dialysis(IPD). The causes of chronic renal failure were diabetes and non-diabetes.-

Exclusion Criteria:

history of allergy to thiazolidinediones and fenofibrate; history of any sever adverse event for fibrate that can't be tolerated by the patients; patient can not be follow-up regularly; history of myocardial infarction(MI) or coronary artery bypass graft (CABG) surgery within the past 1 month, history of cerebral vascular accident (CVA) or percutaneous transluminal coronary angioplasty(PTCA) within the past 6 months; chronic use of non-steroidal anti-inflammatory drugs(NSAIDs), steroids or immunosuppressives; patient with the acute infection; patient with malignant tumor; have the evidence of severe hepatic injury (ALT/AST>100u/L).-