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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
NCT01021878
First received: November 27, 2009
Last updated: September 30, 2014
Last verified: September 2014
Results First Received: June 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Disorders Associated With Peritoneal Dialysis
Interventions: Other: icodextrin
Other: Dianeal

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Icodextrin

glucose sparing alternative dialysis solution

icodextrin: glucose sparing dialysis solution

N=33

Dextrose

Control group, standard treatment

Dianeal: glucose based dialysis solution

N=27


Participant Flow:   Overall Study
    Icodextrin     Dextrose  
STARTED     33     27  
Completed Follow-up     17     17  
COMPLETED     17     17  
NOT COMPLETED     16     10  
Lost to Follow-up                 4                 3  
Death                 0                 1  
Adverse Event                 6                 5  
Transplantation                 6                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
From October 2009 to February 2012 60 patients were randomly assigned to the intervention (n=33) or the control (n=27) group. Completed follow-up was achieved for 34 patients, of which 17 of the control and 17 of the study group.

Reporting Groups
  Description
Icodextrin

glucose sparing alternative dialysis solution

icodextrin: glucose sparing dialysis solution

Dextrose

Control group, standard treatment

Dianeal: glucose based dialysis solution

Total Total of all reporting groups

Baseline Measures
    Icodextrin     Dextrose     Total  
Number of Participants  
[units: participants]
  33     27     60  
Age  
[units: years]
Median ± Standard Deviation
  50.1  ± 15.5     54.1  ± 17.4     52.1  ± 16.45  
Gender  
[units: participants]
     
Female     18     15     33  
Male     15     12     27  
Region of Enrollment  
[units: participants]
     
Brazil     33     27     60  
Study-Specific Measure  
[units: IR┬áscore]
Mean ± Standard Deviation
  2.10  ± 1.10     1.77  ± 1.00     1.95  ± 1.05  



  Outcome Measures
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1.  Primary:   Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor   [ Time Frame: 3 months ]

2.  Secondary:   Oral Fasting Serum Glucose   [ Time Frame: 3 months ]

3.  Secondary:   Serum Insulin   [ Time Frame: 3 months ]

4.  Secondary:   Glycated Hemoglobin   [ Time Frame: 3 months ]

5.  Secondary:   Total Ultrafiltration   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Roberto Pecoits-Filho and Dr. Thyago P. Moraes
Organization: Pontifícia Universidade Católica do Paraná
phone: 554132713150
e-mail: r.pecoits@pucpr.br


No publications provided


Responsible Party: Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier: NCT01021878     History of Changes
Other Study ID Numbers: PUCPR 01
Study First Received: November 27, 2009
Results First Received: June 24, 2014
Last Updated: September 30, 2014
Health Authority: Brazil: Ethics Committee