MedTrace Logo

Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients

NCT01021878 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-10-01

Study results available
· View outcomes & findings →

Summary

1. LOCATION OF STUDY: Multicentric study in Brazil.
2. PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with those produced by 2,5% glucose for the long-dwell.
3. PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the differences with regard to baseline values of this variable for the two groups as well as in each group, which showed control of the glucose metabolism.

STAGE OF THE STUDY : Phase IV postmarket study

DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.

SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30 Dianeal® 60 30

Duration: 1 year.

Conditions

  • Disorders Associated With Peritoneal Dialysis

Interventions

OTHER

icodextrin

glucose sparing dialysis solution

OTHER

Dianeal

glucose based dialysis solution

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Pontifícia Universidade Católica do Paraná

    lead OTHER

Principal Investigators

  • Roberto Pecoits-Filho, MD, PhD · Pontificia Universidade Catolica do Parana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-11-30
Completion
2012-02-29

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT01021878 on ClinicalTrials.gov