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Pioglitazone Attenuates Dysmetabolism in Peritoneal Dialysis (PD) Patients

NCT01258322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-12-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pioglitazone

The patients were randomized divided into 2 groups; one received no pioglitazone for lowing triglyceride, one with oral pioglitazone (Actos®, Takeda®) 15mg once daily for 12 weeks. After a four-week wash out, patients then continued with the alternate therapy.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Tongying Zhu, MD and PhD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-09-30
Completion
2008-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01258322 on ClinicalTrials.gov