drugset / Trial / NCT01258322

Pioglitazone Attenuates Dysmetabolism in Peritoneal Dialysis (PD) Patients

NCT01258322

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2008-01
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule 15 mg Oral

Indications